Pulp NecrosisNCT03589560
Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Anterior Teeth
A study testing Biodentine and Mineral Trioxide Aggregate in people with Pulp Necrosis, run by Cairo University.
Trial summary
the object of this study is to evaluate clinically and radiographically the effect of using Biodentine and Mineral Trioxide Aggregate as coronal plug materials in revascularization of non-vital immature teeth Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necrosis
- What is being tested?
- Biodentine and Mineral Trioxide Aggregate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2015to 15 Jan 2018
- Phase
- Interventional
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients free from any systemic diseases that may hinder the normal healing process.
- Age from 8-15 y
- Tooth with immature root apex (apical opening greater than 1mm)
- Traumatically or cariously exposed single rooted teeth
- Non vital permanent anterior tooth with apical periodontitis/abscess
- Pulp space not requiring post and core for final restoration.
Who cannot join
- Patients having allergy to medicaments or antibiotics necessary to complete procedure.
- Tooth with vital pulp or complete root formation.
- Teeth with internal or external root resorption.
- Un-cooperative patient
About this study
Official title: Clinical and Radiographic Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Permanent Anterior Teeth (Randomized Clinical Study)
the object of this study is to evaluate clinically and radiographically the effect of using Biodentine and Mineral Trioxide Aggregate as coronal plug materials in revascularization of non-vital immature teeth
Read the detailed description
Traumatic injury to the anterior teeth is commonly found among young children, represent one third in boys and one fourth in girls. Because the root development completed two years after eruption of the tooth into the oral cavity, an incomplete root development is one of the most common complication seen in traumatized teeth. Loss of pulp vitality before dentine deposition is completed, leaves a weak root more susceptible to fracture as a result of the thin dentinal walls. It will also lead to a poor crown/root ratio, with possible periodontal injury as a result of increased mobility.
Several techniques have been advocated to manage the open apex of immature teeth, including calcium hydroxide (Ca(OH)2) apexification or apical barrier technique with Mineral Trioxide Aggregate (MTA). Although these techniques were successful in obtaining apical closure and healing of the apical pathosis, they have certain disadvantages, as the root walls of the immature tooth remain thin and short as hard tissue barrier formation only occurs apically, with no further root development.
As an replacement to traditional methods, the use of a regenerative endodontic procedure has been recommended as it may strengthen the root walls through the deposition of hard tissue and promote the development of a normal apical morphology. MTA was chosen to be placed over blood clot to provide excellent seal and it was considered the recommended material for regenerative procedures.The application of MTA over a blood clot was technically difficult, and condensation resulted in displacement of the material apically. Another important note was the prolonged setting time of MTA which resulted in postponing placement of composite restoration to next appointments and post-treatment tooth discoloration.
Biodentine has the same mechanical properties as human dentine, very low cytotoxicity and overcome clinical drawbacks of white MTA. It had better consistency and allow its condensation without any apical displacement. Biodentine sets within twelve minutes, which allow placement of composite restoration in the same appointment. Biodentine is tooth-colored and doesn't cause the discoloration resulted from the presence of the material at level of the orifice.
- Conditions
- Pulp Necrosis
- Being tested
- Biodentine, Mineral Trioxide Aggregate
- Keywords
- revascularization, necrotic, immature, coronal plug
- Medical subject headings
- Dental Pulp Necrosis, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineDrug
Also called Dentine substitute material
a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.
Mineral Trioxide AggregateDrug
Also called MTA
a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Experimental | 3-4 mm of Biodentine (Septodont, St. Maur-des-Fosses, France) was applied over the clot carefully in group I by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization. Receives: Drug: Biodentine |
| Mineral Trioxide Aggregate | Active comparator | 3-4 mm of white Mineral Trioxide Aggregate (Angelus, Londrina, Brazil) was applied over the clot in group II by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization. Receives: Drug: Mineral Trioxide Aggregate |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain on biting
Binary outcome (Present or absent). Assessed by asking the patient
Measured: 3 months
pain on biting
Binary outcome (Present or absent). Assessed by asking the patient
Measured: 6 months
pain on biting
Binary outcome (Present or absent). Assessed by asking the patient
Measured: 9 months
pain on biting
Binary outcome (Present or absent). Assessed by asking the patient
Measured: 12 months
Secondary outcomes (7)
pain on percussion
Binary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror
Measured: 3, 6, 9, 12 month
swelling
Binary outcome (Present or absent). Assessed by visual examination of labial vestibule
Measured: 3, 6, 9, 12 month
mobility
Binary outcome (Present or absent). Assessed by applying pressure with the ends of 2 metal instruments
Measured: 3, 6, 9, 12 month
Sinus or fistula
Binary outcome (Present or absent). Assessed by visual examination of labial vestibule
Measured: 3, 6, 9, 12 month
crown discoloration
Binary outcome (Present or absent). Assessed by visual examination of the crown
Measured: 3, 6, 9, 12 month
root lengthening
Evaluated radiographically using DIGORA software.Unit of measurements were mm
Measured: 3, 6, 9, 12 month
root lengthening
Evaluated radiographically using DIGORA software.Unit of measurements were percent
Measured: 3, 6, 9, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start15 Jan 2015
- Primary completion15 Aug 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohsen Aly, Cairo University
- Investigators
- Randa Youssef, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589560
- Sponsor's protocol ID
- pulp revascularization
- Status last verified
- Jul 2018
- First submitted
- 24 Jun 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Permanent Anterior Teeth (Randomized Clinical Study)
- ClinicalTrials.gov ID
- NCT03589560
- Acronym / sponsor ID
- pulp revascularization
- Conditions
- Pulp Necrosis
- Keywords
- revascularization, necrotic, immature, coronal plug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 18 Jul 2018 (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 object of this study is to evaluate clinically and radiographically the effect of using Biodentine and Mineral Trioxide Aggregate as coronal plug materials in revascularization of non-vital immature teeth
Detailed description
Traumatic injury to the anterior teeth is commonly found among young children, represent one third in boys and one fourth in girls. Because the root development completed two years after eruption of the tooth into the oral cavity, an incomplete root development is one of the most common complication seen in traumatized teeth. Loss of pulp vitality before dentine deposition is completed, leaves a weak root more susceptible to fracture as a result of the thin dentinal walls. It will also lead to a poor crown/root ratio, with possible periodontal injury as a result of increased mobility.
Several techniques have been advocated to manage the open apex of immature teeth, including calcium hydroxide (Ca(OH)2) apexification or apical barrier technique with Mineral Trioxide Aggregate (MTA). Although these techniques were successful in obtaining apical closure and healing of the apical pathosis, they have certain disadvantages, as the root walls of the immature tooth remain thin and short as hard tissue barrier formation only occurs apically, with no further root development.
As an replacement to traditional methods, the use of a regenerative endodontic procedure has been recommended as it may strengthen the root walls through the deposition of hard tissue and promote the development of a normal apical morphology. MTA was chosen to be placed over blood clot to provide excellent seal and it was considered the recommended material for regenerative procedures.The application of MTA over a blood clot was technically difficult, and condensation resulted in displacement of the material apically. Another important note was the prolonged setting time of MTA which resulted in postponing placement of composite restoration to next appointments and post-treatment tooth discoloration.
Biodentine has the same mechanical properties as human dentine, very low cytotoxicity and overcome clinical drawbacks of white MTA. It had better consistency and allow its condensation without any apical displacement. Biodentine sets within twelve minutes, which allow placement of composite restoration in the same appointment. Biodentine is tooth-colored and doesn't cause the discoloration resulted from the presence of the material at level of the orifice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Experimental | Drug: Biodentine3-4 mm of Biodentine (Septodont, St. Maur-des-Fosses, France) was applied over the clot carefully in group I by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization. |
| Mineral Trioxide Aggregate | Active comparator | Drug: Mineral Trioxide Aggregate3-4 mm of white Mineral Trioxide Aggregate (Angelus, Londrina, Brazil) was applied over the clot in group II by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients free from any systemic diseases that may hinder the normal healing process.
- Age from 8-15 y
- Tooth with immature root apex (apical opening greater than 1mm)
- Traumatically or cariously exposed single rooted teeth
- Non vital permanent anterior tooth with apical periodontitis/abscess
Key exclusion criteria (4 listed)
- Patients having allergy to medicaments or antibiotics necessary to complete procedure.
- Tooth with vital pulp or complete root formation.
- Teeth with internal or external root resorption.
- Un-cooperative patient
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 |
|---|---|---|
| BiodentineAlso: Dentine substitute materiala procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis. | Drug | Biodentine |
| Mineral Trioxide AggregateAlso: MTAa procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis. | Drug | Mineral Trioxide Aggregate |
Primary outcome
pain on biting
Time frame: 3 months
Binary outcome (Present or absent). Assessed by asking the patient
pain on biting
Time frame: 6 months
Binary outcome (Present or absent). Assessed by asking the patient
pain on biting
Time frame: 9 months
Binary outcome (Present or absent). Assessed by asking the patient
pain on biting
Time frame: 12 months
Binary outcome (Present or absent). Assessed by asking the patient
7 secondary outcomes
pain on percussion
Time frame: 3, 6, 9, 12 month
swelling
Time frame: 3, 6, 9, 12 month
mobility
Time frame: 3, 6, 9, 12 month
Sinus or fistula
Time frame: 3, 6, 9, 12 month
crown discoloration
Time frame: 3, 6, 9, 12 month
root lengthening
Time frame: 3, 6, 9, 12 month
root lengthening
Time frame: 3, 6, 9, 12 month
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 18 Jul 2018.
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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.
Randa Youssef, PHD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Biodentine and Mineral Trioxide Aggregate in people with Pulp Necrosis, run by Cairo University.
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 6 inclusion and 4 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
pain on biting (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2018.