PulpitisPhase 4NCT04795830
Bioactive Materials in Pulp Therapy of Primary Teeth
A Phase 4 study testing Bioceramic root repair material as pulp dressing in pulpotomy in primary molars and Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA) in people with Pulpitis and Pulp Disease, Dental, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the clinical and radiographic success of a new injectable, fast setting bioceramic root repair material (BC RRM) putty with mineral trioxide aggregate (MTA) in pulpotomy procedures of primary teeth. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis, Pulp Disease, Dental
- What is being tested?
- Bioceramic root repair material as pulp dressing in pulpotomy in primary molars and Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who have a restorable vital deep carious primary molar which is indicated for pulpotomy
- Absence of clinical signs and symptoms; namely pain on percussion, tooth mobility, presence of sinus or fistula or history of swelling
Who cannot join
- Badly broken down, unrestorable teeth
- Teeth with previous pulp therapy treatment
- Presence of uncontrolled bleeding
- Clinical evidence of non-vitality; namely presence of an abscess or a sinus tract or premature mobility
- Radiographic evidence of bone resorption, internal or external root resorption, or periapical or interradicular radiolucency.
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University
Cairo, 11566
About this study
Official title: Clinical and Radiographic Evaluation of Bioactive Materials in Pulp Therapy of Primary Teeth: A Randomized Controlled Trial
The purpose of this study is to compare the clinical and radiographic success of a new injectable, fast setting bioceramic root repair material (BC RRM) putty with mineral trioxide aggregate (MTA) in pulpotomy procedures of primary teeth. The null hypothesis (H0) is that there is no difference in the clinical and radiographic success between the TotalFill® BC RRM™ Fast Set Putty and Produits Dentaires™ (PD™) MTA WHITE when used as a pulp dressing in pulpotomies of primary molars.
Read the detailed description
Dental Caries is the most common chronic disease worldwide and the most common disease of childhood, with increasing prevalence in many countries, including Egypt. About 70% of Egyptian children have some untreated caries experience. This percentage was also reported by an unpublished nationwide survey funded by the World Health Organization (WHO).
Dental decay is the primary cause for oral pain and tooth loss. Toothache as a result of untreated caries is persistent and often severe. In children, the prevalence of dental pain ranges from 5% to 33% and increases with caries severity, child age and decreasing economic status. Untreated caries in children can lead to pain, sepsis and affect the quality of life of children and their families, such as lost school days, family disruption, and the need for costly dental treatment.
Tooth decay has a multifactorial nature of occurrence. The carious process is a result of an imbalance between pathogenic factors, namely the high frequency of fermentable sugar intake and the increase in acid-producing bacteria, which outweigh host protective factors in the oral cavity favoring demineralization of the tooth structure. This on-going process progresses more rapidly in primary compared to permanent teeth which may be attributed to the different anatomical characteristics between them. Thinner enamel and dentin as well as larger pulp and higher pulp horns make deciduous teeth more vulnerable to degradation of hard tissues and pulpal affection. Approximately 75% of deep carious lesions were found clinically with pulp exposure.
The deciduous teeth are important for mastication, speech, esthetics as well as for the preservation of arch integrity and space for the permanent successors. Hence, pulp therapy is the appropriate alternative to extraction for pulpally affected primary teeth in most clinical situations. Depending on the extension of the carious process, different pulp treatment modalities are available, pulpotomy being the most common among them with a high success rate of 82.6%. Complete pulpotomy involves the complete removal of the inflamed and/or infected coronal pulp tissue and the application of a medicament to the pulp chamber or radicular pulp remnants allowing healing of the radicular pulp tissue.
For decades, formocresol had been the gold standard material for pulpotomy procedures in primary teeth until mineral trioxide aggregate (MTA) was introduced. According to several systematic reviews and meta-analysis, MTA presents superior performance and higher success rates compared to other materials in pulpotomy of primary teeth. MTA pulpotomy has become a safe and biocompatible treatment alternative with success rates comparable to formocresol pulpotomy.
Although MTA has been recently considered the gold standard material for pulpotomy procedures, some drawbacks such as poor handling and long setting time are challenging when used as pulpotomy dressing in primary teeth of children. Thus, the evaluation of the clinical and radiographic performance of other materials such as a bioceramic root repair material in a convenient injectable form with faster setting time is of paramount importance for the management of dental caries in the pediatric patient.
Evidence is lacking as to the effectiveness of bioceramic materials as pulp dressing in the primary dentition and to their clinical or radiographic success compared to other materials. Different bioceramic root repair materials (BC RRM) have been used in the adult population. To our knowledge, there are no studies evaluating the use of BC RRM in pulp therapy of deciduous molars. Since MTA has been recently advocated to be the gold standard in pulp therapy, it is chosen as the comparator in the control group.
A two arm, parallel group, randomized controlled trial, with 1:1 allocation ratio to either study group or control group, is the study of choice to test the null hypothesis and answer the research question.
The study will be conducted at the outpatient clinic of the department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University. This research will be reviewed by the Research Ethics Committee and Institutional Review Board, Faculty of Dentistry, Ain Shams University. A verbal as well as a written consent will be obtained from the caregivers of the participants after explaining the objectives of the study and assuring complete confidentiality of data. All caregivers and participants will be informed that they have the right to withdraw from the study at any time. Moreover, participants 6 years and older will be requested to sign an assent form after an age appropriate explanation of the trial procedures and their objectives. All consent and assent forms are translated into Arabic.
A power analysis was designed to have adequate power to apply a statistical test of the research hypothesis (null hypothesis) that there was no difference between the clinical and radiographic success between the bioceramic root repair material and Mineral Trioxide Aggregate when used as a pulp dressing in pulpotomies of primary molars. By adopting an alpha (α) level of 0.05 (5%), a beta (β) level of 0.20 (20%) i.e. power=80%, and using an effect size (w=0.430); the predicted sample size (n) was found to be a total of (52) teeth; i.e. (26) for each group and (13) for each subgroup. Sample size calculation was performed using G*Power version 3.1.9.2.44 The sample size was increased by 15% to (30) primary molars per group, i.e. (15) molars per subgroup and (60) in total to compensate for drop-outs.
The study interventions are expected to be conducted from 2020 until 2022. After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in the patient's examination sheet. Enrolled participant's tooth will be then randomly allocated to the experiment or control intervention group. Participant will be recalled for follow up assessments at 1, 3, 6 and 12 months. A 14 day window, defined as 7 days before and 7 days after the due date, will be available to complete the 1 and 3 month follow-up evaluations and a 28 day window, defined as 7 days before and 21 days after the due date, will be available to complete the 6 and 12 month follow up evaluations.
Participants' data will be recorded in an examination sheet and stored as hard copy files. Patients' information will be regarded as confidential and will never be revealed at all times. This will be ensured by assigning codes to participants' teeth undergoing intervention.
Several attempts will be made calling participants on the phone for clinical and radiographic follow up appointments at 1, 3, 6 and 12 months. Patients who fail to show up at the follow up examinations, within the defined follow up windows, will be automatically excluded from the study. Patients who are no longer willing to continue in the study have the right to quit at any time and will be offered to continue dental treatment at the department's outpatient clinic.
All data will be collected, tabulated, summarized and statistically analyzed using the Statistical Packages for Social Sciences (SPSS) software.
Regular unannounced audits by the Research Ethics Committee, Faculty of Dentistry, Ain Shams University are expected as to ascertain that protocol guidelines are followed throughout the study. In addition to the study supervisors, independent staff members and clinic supervisors of the Department of Pediatric Dentistry and Dental Public Health, Ain Shams University monitor clinical performance to ensure adherence to best practice.
MTA and BC RRM have been shown to have no adverse effects on healthy patients. On the contrary, they have been shown to be biomimetic and biocompatible when used for endodontic procedures in adults. Failure of pulp therapy and abscess formation might occur as with all materials used in pulpotomies to this date. Short term follow up will avoid the occurrence of any serious condition and will allow its instant treatment. Any adverse event will be recorded and managed promptly. Furthermore, in case of consistent failures, the use of the experimental material will be stopped and patients will be treated with another modality.
- Conditions
- Pulpitis, Pulp Disease, Dental
- Being tested
- Bioceramic root repair material as pulp dressing in pulpotomy in primary molars, Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA)
- Keywords
- Pulpitis, Pulp Inflammation, Primary dentition, bioceramic, root repair material, deciduous dentition, pulpotomy, MTA, bioactive
- Medical subject headings
- Pulpitis, Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioceramic root repair material as pulp dressing in pulpotomy in primary molarsCombination product
Also called Bioceramic Root Repair Material Fast Set Putty (BC RRM-F), TotalFill® BC RRM™ Fast Set Putty, FKG Dentaire SA, Switzerland
BC RRM-F, a novel premixed bioceramic-based putty, can be used as a pulp dressing to promote pulp healing and repair with an added convenience for the pediatric patient. The aim of the present study is to evaluate the efficacy of a bioceramic root repair material as pulp dressing in pulpotomy in primary molars. The success of this material as pulpotomy dressing in primary molars will be evaluated clinically and radiographically in comparison to mineral trioxide aggregate pulpotomy. Both materials will be compared in terms of ease of handling, time to perform procedure and convenience of application. Each material's success will be evaluated by comparing its performance with or without the added peripheral seal of a stainless steel crown.
Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA)Combination product
Also called PD™ MTA WHITE, Produits Dentaires SA, Switzerland
MTA's sealing ability, biocompatibility, ability to stimulate hard tissue formation and its regenerative ability when used in contact with pulp tissues has made MTA pulpotomy the new gold standard as opposed to formocresol pulpotomy in treating the amputated pulp stumps of primary molars.
| Study group | Role | What they receive |
|---|---|---|
| Control group with Stainless Steel Crown (SSC) | Active comparator | After pulpotomy and hemostasis, MTA powder and liquid will be mixed according to the manufacturer's instructions and applied via MTA applicator to cover the amputated pulp stumps.
Using a glass ionomer gun, a capsule of GC Corporation's EQUIA Forte High Translucency glass ionomer restorative (GC EQUIA Forte HT Fil Capsule) will be injected to fill the pulp chamber.
Finally, the tooth will be restored with a stainless steel crown. Receives: Combination Product: Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA) |
| Control group with Restoration | Active comparator | After pulpotomy and hemostasis, MTA powder and liquid will be mixed according to the manufacturer's instructions and applied via MTA applicator to cover the amputated pulp stumps.
Using a glass ionomer gun, a capsule of glass ionomer restorative GC EQUIA Forte HT Fil Capsule will be injected to fill the pulp chamber and restore the tooth. Receives: Combination Product: Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA) |
| Study group with Restoration | Experimental | After pulpotomy and hemostasis, BC RRM Fast setting putty will be applied from the manufacturer's syringe using a plastic instrument to cover the amputated pulp stumps.
Using a glass ionomer gun, a capsule of glass ionomer restorative GC EQUIA Forte HT Fil Capsule will be injected to fill the pulp chamber and restore the tooth. Receives: Combination Product: Bioceramic root repair material as pulp dressing in pulpotomy in primary molars |
| Study group with Stainless Steel Crown (SSC) | Experimental | After pulpotomy and hemostasis, BC RRM Fast setting putty will be applied from the manufacturer's syringe using a plastic instrument to cover the amputated pulp stumps.
Using a glass ionomer gun, a capsule of glass ionomer restorative GC EQUIA Forte HT Fil Capsule will be injected to fill the pulp chamber.
Finally, the tooth will be restored with a stainless steel crown. Receives: Combination Product: Bioceramic root repair material as pulp dressing in pulpotomy in primary molars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success of Pulpotomy Treatment after 1 month follow up
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing:
1-month evaluation
Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy.
Clinical findings:
Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Measured: 1 month
Clinical Success of Pulpotomy Treatment after 3 months follow up
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing:
3-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy.
Clinical findings:
Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Measured: 3 months
Clinical Success of Pulpotomy Treatment after 6 months follow up
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing:
6-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy.
Clinical findings:
Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Measured: 6 months
Clinical Success of Pulpotomy Treatment after 12 months follow up
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing:
12-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy.
Clinical findings:
Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Measured: 12 months
Radiographic Success of Pulpotomy Treatment after 1 month follow up
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing:
1-month evaluation
Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy.
Radiographic findings:
Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
Measured: 1 month
Radiographic Success of Pulpotomy Treatment after 3 months follow up
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing:
3-months evaluation
Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy.
Radiographic findings:
Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
Measured: 3 months
Radiographic Success of Pulpotomy Treatment after 6 months follow up
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing:
6-months evaluation
Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy.
Radiographic findings:
Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
Measured: 6 months
Radiographic Success of Pulpotomy Treatment after 12 months follow up
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing:
12-months evaluation
Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy.
Radiographic findings:
Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
Measured: 12 months
Secondary outcomes (3)
Ease of handling of material
Both materials will be compared in terms of ease of handling by answering the following Yes or No questions:
Does the material stick to the plastic instrument when inserted into the cavity? Does the material set before adequate amount is applied to cover pulp stumps (adequate working time)?
Measured: during procedure
Time to perform procedure
Both materials will be compared in terms of time to perform procedure by measuring the time (in minutes) taken to perform the procedure using a stopwatch.
Measured: during procedure
Convenience of application
Both materials will be compared in terms of convenience of application by answering the following Yes or No questions:
Does the material adapt poorly to the cavity walls when observed by the naked eye? Does the patient feel pain or discomfort when the material is being applied to the pulp stumps?
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Aug 2021
- Primary completion1 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in the patient's examination sheet. Enrolled participant's tooth will be then randomly allocated to the experiment or control intervention group. Participant will be recalled for follow up assessments at 1, 3, 6 and 12 months. A 14 day window, defined as 7 days before and 7 days after the due date, will be available to complete the 1 and 3 month follow-up evaluations and a 28 day window, defined as 7 days before and 21 days after the due date, will be available to complete the 6 and 12 month follow up evaluations.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Hisham Abdelwahab, Ain Shams University
- Investigators
- Dina Abdelwahab, M.Sc., Principal investigator, Department of Pediatric Dentistry and Dental Public Health, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795830
- Sponsor's protocol ID
- PED 20-5D
- Status last verified
- Jul 2023
- First submitted
- 21 Feb 2021
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelwahab DH, Kabil NS, Badran AS, Darwish D, Abd El Geleel OM. One-year radiographic and clinical performance of bioactive materials in primary molar pulpotomy: A randomized controlled trial. J Dent. 2024 Apr;143:104864. doi: 10.1016/j.jdent.2024.104864. Epub 2024 Jan 26.
PubMed 38281619
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Bioactive Materials in Pulp Therapy of Primary Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04795830
- Acronym / sponsor ID
- PED 20-5D
- Conditions
- Pulpitis, Pulp Disease, Dental
- Keywords
- Pulpitis, Pulp Inflammation, Primary dentition, bioceramic, root repair material, deciduous dentition, pulpotomy, MTA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the clinical and radiographic success of a new injectable, fast setting bioceramic root repair material (BC RRM) putty with mineral trioxide aggregate (MTA) in pulpotomy procedures of primary teeth. The null hypothesis (H0) is that there is no difference in the clinical and radiographic success between the TotalFill® BC RRM™ Fast Set Putty and Produits Dentaires™ (PD™) MTA WHITE when used as a pulp dressing in pulpotomies of primary molars.
Detailed description
Dental Caries is the most common chronic disease worldwide and the most common disease of childhood, with increasing prevalence in many countries, including Egypt. About 70% of Egyptian children have some untreated caries experience. This percentage was also reported by an unpublished nationwide survey funded by the World Health Organization (WHO).
Dental decay is the primary cause for oral pain and tooth loss. Toothache as a result of untreated caries is persistent and often severe. In children, the prevalence of dental pain ranges from 5% to 33% and increases with caries severity, child age and decreasing economic status. Untreated caries in children can lead to pain, sepsis and affect the quality of life of children and their families, such as lost school days, family disruption, and the need for costly dental treatment.
Tooth decay has a multifactorial nature of occurrence. The carious process is a result of an imbalance between pathogenic factors, namely the high frequency of fermentable sugar intake and the increase in acid-producing bacteria, which outweigh host protective factors in the oral cavity favoring demineralization of the tooth structure. This on-going process progresses more rapidly in primary compared to permanent teeth which may be attributed to the different anatomical characteristics between them. Thinner enamel and dentin as well as larger pulp and higher pulp horns make deciduous teeth more vulnerable to degradation of hard tissues and pulpal affection. Approximately 75% of deep carious lesions were found clinically with pulp exposure.
The deciduous teeth are important for mastication, speech, esthetics as well as for the preservation of arch integrity and space for the permanent successors. Hence, pulp therapy is the appropriate alternative to extraction for pulpally affected primary teeth in most clinical situations. Depending on the extension of the carious process, different pulp treatment modalities are available, pulpotomy being the most common among them with a high success rate of 82.6%. Complete pulpotomy involves the complete removal of the inflamed and/or infected coronal pulp tissue and the application of a medicament to the pulp chamber or radicular pulp remnants allowing healing of the radicular pulp tissue.
For decades, formocresol had been the gold standard material for pulpotomy procedures in primary teeth until mineral trioxide aggregate (MTA) was introduced. According to several systematic reviews and meta-analysis, MTA presents superior performance and higher success rates compared to other materials in pulpotomy of primary teeth. MTA pulpotomy has become a safe and biocompatible treatment alternative with success rates comparable to formocresol pulpotomy.
Although MTA has been recently considered the gold standard material for pulpotomy procedures, some drawbacks such as poor handling and long setting time are challenging when used as pulpotomy dressing in primary teeth of children. Thus, the evaluation of the clinical and radiographic performance of other materials such as a bioceramic root repair material in a convenient injectable form with faster setting time is of paramount importance for the management of dental caries in the pediatric patient.
Evidence is lacking as to the effectiveness of bioceramic materials as pulp dressing in the primary dentition and to their clinical or radiographic success compared to other materials. Different bioceramic root repair materials (BC RRM) have been used in the adult population. To our knowledge, there are no studies evaluating the use of BC RRM in pulp therapy of deciduous molars. Since MTA has been recently advocated to be the gold standard in pulp therapy, it is chosen as the comparator in the control group.
A two arm, parallel group, randomized controlled trial, with 1:1 allocation ratio to either study group or control group, is the study of choice to test the null hypothesis and answer the research question.
The study will be conducted at the outpatient clinic of the department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University. This research will be reviewed by the Research Ethics Committee and Institutional Review Board, Faculty of Dentistry, Ain Shams University. A verbal as well as a written consent will be obtained from the caregivers of the participants after explaining the objectives of the study and assuring complete confidentiality of data. All caregivers and participants will be informed that they have the right to withdraw from the study at any time. Moreover, participants 6 years and older will be requested to sign an assent form after an age appropriate explanation of the trial procedures and their objectives. All consent and assent forms are translated into Arabic.
A power analysis was designed to have adequate power to apply a statistical test of the research hypothesis (null hypothesis) that there was no difference between the clinical and radiographic success between the bioceramic root repair material and Mineral Trioxide Aggregate when used as a pulp dressing in pulpotomies of primary molars. By adopting an alpha (α) level of 0.05 (5%), a beta (β) level of 0.20 (20%) i.e. power=80%, and using an effect size (w=0.430); the predicted sample size (n) was found to be a total of (52) teeth; i.e. (26) for each group and (13) for each subgroup. Sample size calculation was performed using G*Power version 3.1.9.2.44 The sample size was increased by 15% to (30) primary molars per group, i.e. (15) molars per subgroup and (60) in total to compensate for drop-outs.
The study interventions are expected to be conducted from 2020 until 2022. After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in the patient's examination sheet. Enrolled participant's tooth will be then randomly allocated to the experiment or control intervention group. Participant will be recalled for follow up assessments at 1, 3, 6 and 12 months. A 14 day window, defined as 7 days before and 7 days after the due date, will be available to complete the 1 and 3 month follow-up evaluations and a 28 day window, defined as 7 days before and 21 days after the due date, will be available to complete the 6 and 12 month follow up evaluations.
Participants' data will be recorded in an examination sheet and stored as hard copy files. Patients' information will be regarded as confidential and will never be revealed at all times. This will be ensured by assigning codes to participants' teeth undergoing intervention.
Several attempts will be made calling participants on the phone for clinical and radiographic follow up appointments at 1, 3, 6 and 12 months. Patients who fail to show up at the follow up examinations, within the defined follow up windows, will be automatically excluded from the study. Patients who are no longer willing to continue in the study have the right to quit at any time and will be offered to continue dental treatment at the department's outpatient clinic.
All data will be collected, tabulated, summarized and statistically analyzed using the Statistical Packages for Social Sciences (SPSS) software.
Regular unannounced audits by the Research Ethics Committee, Faculty of Dentistry, Ain Shams University are expected as to ascertain that protocol guidelines are followed throughout the study. In addition to the study supervisors, independent staff members and clinic supervisors of the Department of Pediatric Dentistry and Dental Public Health, Ain Shams University monitor clinical performance to ensure adherence to best practice.
MTA and BC RRM have been shown to have no adverse effects on healthy patients. On the contrary, they have been shown to be biomimetic and biocompatible when used for endodontic procedures in adults. Failure of pulp therapy and abscess formation might occur as with all materials used in pulpotomies to this date. Short term follow up will avoid the occurrence of any serious condition and will allow its instant treatment. Any adverse event will be recorded and managed promptly. Furthermore, in case of consistent failures, the use of the experimental material will be stopped and patients will be treated with another modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in the patient's examination sheet. Enrolled participant's tooth will be then randomly allocated to the experiment or control intervention group. Participant will be recalled for follow up assessments at 1, 3, 6 and 12 months. A 14 day window, defined as 7 days before and 7 days after the due date, will be available to complete the 1 and 3 month follow-up evaluations and a 28 day window, defined as 7 days before and 21 days after the due date, will be available to complete the 6 and 12 month follow up evaluations.
| Arm | Type | Receives |
|---|---|---|
| Control group with Stainless Steel Crown (SSC) | Active comparator | Combination Product: Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA)After pulpotomy and hemostasis, MTA powder and liquid will be mixed according to the manufacturer's instructions and applied via MTA applicator to cover the amputated pulp stumps. Using a glass ionomer gun, a capsule of GC Corporation's EQUIA Forte High Translucency glass ionomer restorative (GC EQUIA Forte HT Fil Capsule) will be injected to fill the pulp chamber. Finally, the tooth will be restored with a stainless steel crown. |
| Control group with Restoration | Active comparator | Combination Product: Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA)After pulpotomy and hemostasis, MTA powder and liquid will be mixed according to the manufacturer's instructions and applied via MTA applicator to cover the amputated pulp stumps. Using a glass ionomer gun, a capsule of glass ionomer restorative GC EQUIA Forte HT Fil Capsule will be injected to fill the pulp chamber and restore the tooth. |
| Study group with Restoration | Experimental | Combination Product: Bioceramic root repair material as pulp dressing in pulpotomy in primary molarsAfter pulpotomy and hemostasis, BC RRM Fast setting putty will be applied from the manufacturer's syringe using a plastic instrument to cover the amputated pulp stumps. Using a glass ionomer gun, a capsule of glass ionomer restorative GC EQUIA Forte HT Fil Capsule will be injected to fill the pulp chamber and restore the tooth. |
| Study group with Stainless Steel Crown (SSC) | Experimental | Combination Product: Bioceramic root repair material as pulp dressing in pulpotomy in primary molarsAfter pulpotomy and hemostasis, BC RRM Fast setting putty will be applied from the manufacturer's syringe using a plastic instrument to cover the amputated pulp stumps. Using a glass ionomer gun, a capsule of glass ionomer restorative GC EQUIA Forte HT Fil Capsule will be injected to fill the pulp chamber. Finally, the tooth will be restored with a stainless steel crown. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients who have a restorable vital deep carious primary molar which is indicated for pulpotomy
- Absence of clinical signs and symptoms; namely pain on percussion, tooth mobility, presence of sinus or fistula or history of swelling
Key exclusion criteria (6 listed)
- Badly broken down, unrestorable teeth
- Teeth with previous pulp therapy treatment
- Presence of uncontrolled bleeding
- Clinical evidence of non-vitality; namely presence of an abscess or a sinus tract or premature mobility
- Radiographic evidence of bone resorption, internal or external root resorption, or periapical or interradicular radiolucency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioceramic root repair material as pulp dressing in pulpotomy in primary molarsAlso: Bioceramic Root Repair Material Fast Set Putty (BC RRM-F), TotalFill® BC RRM™ Fast Set Putty, FKG Dentaire SA, SwitzerlandBC RRM-F, a novel premixed bioceramic-based putty, can be used as a pulp dressing to promote pulp healing and repair with an added convenience for the pediatric patient. The aim of the present study is to evaluate the efficacy of a bioceramic root repair material as pulp dressing in pulpotomy in primary molars. The success of this material as pulpotomy dressing in primary molars will be evaluated clinically and radiographically in comparison to mineral trioxide aggregate pulpotomy. Both materials will be compared in terms of ease of handling, time to perform procedure and convenience of application. Each material's success will be evaluated by comparing its performance with or without the added peripheral seal of a stainless steel crown. | Combination product | Study group with Restoration, Study group with Stainless Steel Crown (SSC) |
| Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA)Also: PD™ MTA WHITE, Produits Dentaires SA, SwitzerlandMTA's sealing ability, biocompatibility, ability to stimulate hard tissue formation and its regenerative ability when used in contact with pulp tissues has made MTA pulpotomy the new gold standard as opposed to formocresol pulpotomy in treating the amputated pulp stumps of primary molars. | Combination product | Control group with Restoration, Control group with Stainless Steel Crown (SSC) |
Primary outcome
Clinical Success of Pulpotomy Treatment after 1 month follow up
Time frame: 1 month
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 1-month evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Clinical Success of Pulpotomy Treatment after 3 months follow up
Time frame: 3 months
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 3-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Clinical Success of Pulpotomy Treatment after 6 months follow up
Time frame: 6 months
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 6-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Clinical Success of Pulpotomy Treatment after 12 months follow up
Time frame: 12 months
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 12-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Radiographic Success of Pulpotomy Treatment after 1 month follow up
Time frame: 1 month
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 1-month evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
Radiographic Success of Pulpotomy Treatment after 3 months follow up
Time frame: 3 months
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 3-months evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
Radiographic Success of Pulpotomy Treatment after 6 months follow up
Time frame: 6 months
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 6-months evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
Radiographic Success of Pulpotomy Treatment after 12 months follow up
Time frame: 12 months
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 12-months evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
3 secondary outcomes
Ease of handling of material
Time frame: during procedure
Time to perform procedure
Time frame: during procedure
Convenience of application
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 38281619Abdelwahab DH, Kabil NS, Badran AS, Darwish D, Abd El Geleel OM. One-year radiographic and clinical performance of bioactive materials in primary molar pulpotomy: A randomized controlled trial. J Dent. 2024 Apr;143:104864. doi: 10.1016/j.jdent.2024.104864. Epub 2024 Jan 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina Abdelwahab, M.Sc. principal investigator
Department of Pediatric Dentistry and Dental Public Health, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bioceramic root repair material as pulp dressing in pulpotomy in primary molars and Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA) in people with Pulpitis and Pulp Disease, Dental, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success of Pulpotomy Treatment after 1 month follow up (time frame: 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04795830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.