Irreversible PulpitisPhase 4NCT05733468
TheraCal LC Coronal Pulpotomy and MTA Coronal Pulpotomy in Mature Permanent Molars
A Phase 4 study testing Theracal LC and MTA in people with Irreversible Pulpitis and Deep Caries, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
To evaluate and compare the clinical and radiographic success rate of TheraCal LC and MTA for coronal pulpotomy of mature permanent molar in 9-14 year children. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Irreversible Pulpitis, Deep Caries
- What is being tested?
- Theracal LC and MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2022to 30 May 2024
- 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient should be between 9-14 years of age
- Intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain
- Permanent molar tooth with deep caries and subsequent pulp bleeding evident upon excavation of caries.
- Rapid exposure to dramatic temperature changes elicited heightened and prolonged episodes of pain even after the thermal stimulus has been removed
- Vital bleeding pulp tissue should be present in all canals after complete pulpotomy
- Diagnosis should be irreversible pulpitis.
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- The tooth is restorable and free from advanced periodontal disease
- Soft tissues around the tooth are normal with no swelling or sinus tract
- Haemostasis should be achieved after complete pulpotomy
- The patient has non-contributory medical history
Who cannot join
- Teeth with immature roots
- Non-restorable
- Pathological mobility
- Pus discharge through an associated sinus tract
- Swelling of associated tissues
- Radiographic internal or external resorption or with any periapical rarefaction
Show all 10Show fewer
- Necrotic pulp upon exposure.
- Bleeding beyond 25 minutes
- Children with severe systemic illness (mental retardation/ severe psychotic disorders), prior history of allergy and any medical condition not permitting the intervention.
- Parents and patients unwilling for participation in the study.
Trial locations and contacts
1 site in 1 country.
India1 site
POST GRADUATE INSTITUTE OF DENTAL SCIENCES Rohtak
Rohtak, Haryana, 124001
About this study
Official title: Comparative Evaluation of Success Rate of TheraCal LC Coronal Pulpotomy and MTA Coronal Pulpotomy in Cariously Exposed Mature Permanent Molars- A Randomized Clinical Study
To evaluate and compare the clinical and radiographic success rate of TheraCal LC and MTA for coronal pulpotomy of mature permanent molar in 9-14 year children.
Read the detailed description
Rationale:
Pain caused by pulpitis is one of the most common reasons for emergency dental visits. The maintenance of the vitality of the dental pulp is one of the crucial targets of modern dentistry, based on the concept of minimally invasive dentistry. Preserving the vital pulp helps in retaining proprioceptive, reparative, tooth sensitivity (innervation), vascularization, and damping functions provided by vital pulp, which help in protecting against harmful stimuli. The traditional treatment modality for permanent mature teeth with irreversible pulpitis is nonsurgical root canal treatment (NSRCT) Moreover, these treatments are lengthy and costly, and are often subject to retreatment. Many biological and clinical studies have shown that the pulp of mature teeth, which is exposed due to carious lesions, is able to be heal, and that VPT should not be limited only to young or asymptomatic teeth. Therefore, a more conservative approach of VPT has been proposed for teeth with irreversible pulpitis. A favorable outcome of this approach depends on two factors: the healing ability of the remaining vital pulp and the biocompatibility of the pulp-capping agents used. Recent studies have observed success rates ranging from 82% to 95% using modern restorative materials in mature permanent teeth, thereby suggesting that pulpotomy can be a useful alternative to RCT in adults. Hydraulic calcium silicate cements (HCSCs) are recommended as the "gold standard" material for conservative treatment of the exposed pulp. MTA is one of the most commonly used and researched material for such purposes with successful clinical outcomes. However, due to certain inherent drawbacks of MTA, such as, extended setting time and tooth discolouration there is a need for the development of newer materials to overcome the challenges associated with MTA. TheraCal LC is a material that creates a new category of resin-modified calcium silicates. It displayed significantly higher calcium-releasing ability and lower solubility than either MTA or calcium hydroxide. This high calcium release has been shown to be critical for the stimulation of apatite formation and secondary dentin bridge formation while providing a mechanical seal of the pulp. TheraCal LC doesn't discolours tooth and also have ease in handling the material with fast setting time. Hence it is been currently used in this study as pulpotomy agent to evaluate the success rate.
Aim:
To evaluate and compare the clinical and radiographic success rate of TheraCal LC and MTA for coronal pulpotomy of mature permanent molars in 9-14 year children.
Objectives :
- To evaluate the clinical and radiographic success rate of MTA for coronal pulpotomy of mature permanent molar
- To evaluate the clinical and radiographic success rate of TheraCal LC for coronal pulpotomy of mature permanent molar.
- To compare the clinical and radiographic success rate of MTA and TheraCal LC for coronal pulpotomy of mature permanent molar immediate post-operative, 1 and 3 months (only clinical), 6 months and 12 months post-operative follow ups.
- To evaluate the post-operative pain for 7 days.
- To evaluate the correlation between the timing of hemostasis achieved and the success rate of coronal pulpotomy.
Materials and methods:
Setting: The study will be carried out in the Outpatient department of Pedodontics and Preventive Dentistry, PGIDS, Rohtak, Haryana.
Study Design: Randomized clinical study
Study Duration: This study shall be completed in a time span of 18 months.
Population: Children aged 9-14 years including both males and females diagnosed with deep carious lesion with irreversible pulpitis recruited from Outpatient department of Pedodontics and Preventive Dentistry, PGIDS, Rohtak, Haryana.
Sample size: Total number of 72 patients will be recruited in this study, with 36 patients allocated to each group
Methods: The children will be positioned supine on dental chair and examined by the dental examiners using dental chair light and mouth mirrors. Use of cotton pellets to dry the teeth and wipe away gross debris. The teeth will be anesthetized using lidocaine 2% with epinephrine 1:80000 and isolated with rubber dam. Access to the pulp chamber will be obtained after the removal of caries and exposure of the vital pulp, using a high speed bur with a water spray. Subsequently, the coronal pulp tissue will be removed down to the canal orifices. The pulp chamber will be irrigated with a light flow of water from the water syringe and excavated. A sterile cotton pellet damped in sterile saline will be placed against the pulp stumps at orifices of the root canals. The bleeding from pulp stump will be evaluated regarding the color and hemostasis achieved within 25 minutes of pressure application. After hemostasis, the test material will be placed as per the study groups.
Group 1- After hemorrhage control , 1-1.5mm of TheraCal LC will be placed on the radicular pulp stumps followed by light curing, followed by the placement of IRM cement and composite restorative material after 2 weeks following the evaluation of postoperative signs and symptoms.
Group 2- After hemorrhage control , a small ball like consistency of 2-3mm of MTA will be placed on the radicular pulp stumps, followed by the placement of IRM and composite restorative material after 2 weeks following the evaluation of postoperative signs and symptoms.
All procedures will be performed in one visit and periapical radiographs will be obtained immediately after treatment. Standardization of the X-ray will be done to have reproducibility of the X-ray during the follow-up period for evaluating the periapical changes post treatment.
Outcome measures: Clinically asymptomatic and no new periapical pathology is formed post treatment.
Statistical analysis: The data collected for each group will be entered in Microsoft excel chart to prepare a master chart. The statistical analysis for the study will be done using SPSS (Statistical Package for the Social Sciences, inc., United States). To assess the effect of independent variable on outcome variables chi square test or fischer test exact shall be utilised along with correlation and regression equation. Statistical significance will be computed and p value_< 0.05 will be considered significant.
- Conditions
- Irreversible Pulpitis, Deep Caries
- Being tested
- Theracal LC, MTA
- Keywords
- MTA, Theracal LC, Mature permanent molars, complete /coronal pulpotomy, Vital Pulp Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theracal LCDrug
Also called Resin-modified calcium silicate
After hemorrhage control , 1-1.5mm of TheraCal LC will be placed on the radicular pulp stumps followed by light curing, followed by the placement of IRM and composite restorative material after 2 weeks
MTADrug
Also called Bioactive calcium silicate
After hemorrhage control , a small ball like consistency of 2-3mm of MTA will be placed on the radicular pulp stumps, followed by the placement of IRM and composite restorative material after 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Theracal LC Pulpotomy | Experimental | 36 children with the cariously exposed mature permanent molar teeth indicated for pulpotomy and fulfilling the inclusion criteria will be taken for the study and coronal pulpotomy will be done till the level of root canal orifice. Receives: Drug: Theracal LC |
| MTA Pulpotomy | Active comparator | 36 children with the cariously exposed mature permanent molar teeth indicated for pulpotomy and fulfilling the inclusion criteria will be taken for the study and coronal pulpotomy will be done till the level of root canal orifice. Receives: Drug: MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate
Clinical success criteria :
- No history of spontaneous pain or discomfort except for the first day after treatment
- No tenderness to palpation or percussion and the tooth is functional
- Normal mobility and probing pocket depth
- Soft tissues around the tooth are normal with no swelling or sinus tract
Measured: Baseline to 12 months
Radiographic success rate
Radiographic success criteria:
- No pathosis evident on the radiograph such as root resorption, new furcal or periapical pathosis
- No canal obliteration
Measured: Baseline to 12 months
Secondary outcomes (2)
Pain assessment
To assess the intensity and incidence of pain post-operatively at every 24 hr interval for 7 days using a Visual Analog Scale (VAS) having a score from 0-10. Score 0 means no pain and score 10 means maximum pain.
Measured: Baseline to 7 days
Hemostasis duration
To evaluate the correlation between the timing of hemostasis achieved and the success rate of coronal pulpotomy
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Jul 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vignesh R, MDS, Principal investigator, POST GRADUATE INSTITUTE OF DENTAL SCIENCES Rohtak,Haryana, India- 124001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733468
- Sponsor's protocol ID
- Dr. Vignesh R
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Success Rate of TheraCal LC Coronal Pulpotomy and MTA Coronal Pulpotomy in Cariously Exposed Mature Permanent Molars- A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05733468
- Acronym / sponsor ID
- Dr. Vignesh R
- Conditions
- Irreversible Pulpitis, Deep Caries
- Keywords
- MTA, Theracal LC, Mature permanent molars, complete /coronal pulpotomy, Vital Pulp Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 17 Feb 2023 (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.
To evaluate and compare the clinical and radiographic success rate of TheraCal LC and MTA for coronal pulpotomy of mature permanent molar in 9-14 year children.
Detailed description
Rationale:
Pain caused by pulpitis is one of the most common reasons for emergency dental visits. The maintenance of the vitality of the dental pulp is one of the crucial targets of modern dentistry, based on the concept of minimally invasive dentistry. Preserving the vital pulp helps in retaining proprioceptive, reparative, tooth sensitivity (innervation), vascularization, and damping functions provided by vital pulp, which help in protecting against harmful stimuli. The traditional treatment modality for permanent mature teeth with irreversible pulpitis is nonsurgical root canal treatment (NSRCT) Moreover, these treatments are lengthy and costly, and are often subject to retreatment. Many biological and clinical studies have shown that the pulp of mature teeth, which is exposed due to carious lesions, is able to be heal, and that VPT should not be limited only to young or asymptomatic teeth. Therefore, a more conservative approach of VPT has been proposed for teeth with irreversible pulpitis. A favorable outcome of this approach depends on two factors: the healing ability of the remaining vital pulp and the biocompatibility of the pulp-capping agents used. Recent studies have observed success rates ranging from 82% to 95% using modern restorative materials in mature permanent teeth, thereby suggesting that pulpotomy can be a useful alternative to RCT in adults. Hydraulic calcium silicate cements (HCSCs) are recommended as the "gold standard" material for conservative treatment of the exposed pulp. MTA is one of the most commonly used and researched material for such purposes with successful clinical outcomes. However, due to certain inherent drawbacks of MTA, such as, extended setting time and tooth discolouration there is a need for the development of newer materials to overcome the challenges associated with MTA. TheraCal LC is a material that creates a new category of resin-modified calcium silicates. It displayed significantly higher calcium-releasing ability and lower solubility than either MTA or calcium hydroxide. This high calcium release has been shown to be critical for the stimulation of apatite formation and secondary dentin bridge formation while providing a mechanical seal of the pulp. TheraCal LC doesn't discolours tooth and also have ease in handling the material with fast setting time. Hence it is been currently used in this study as pulpotomy agent to evaluate the success rate.
Aim:
To evaluate and compare the clinical and radiographic success rate of TheraCal LC and MTA for coronal pulpotomy of mature permanent molars in 9-14 year children.
Objectives :
- To evaluate the clinical and radiographic success rate of MTA for coronal pulpotomy of mature permanent molar
- To evaluate the clinical and radiographic success rate of TheraCal LC for coronal pulpotomy of mature permanent molar.
- To compare the clinical and radiographic success rate of MTA and TheraCal LC for coronal pulpotomy of mature permanent molar immediate post-operative, 1 and 3 months (only clinical), 6 months and 12 months post-operative follow ups.
- To evaluate the post-operative pain for 7 days.
- To evaluate the correlation between the timing of hemostasis achieved and the success rate of coronal pulpotomy.
Materials and methods:
Setting: The study will be carried out in the Outpatient department of Pedodontics and Preventive Dentistry, PGIDS, Rohtak, Haryana.
Study Design: Randomized clinical study
Study Duration: This study shall be completed in a time span of 18 months.
Population: Children aged 9-14 years including both males and females diagnosed with deep carious lesion with irreversible pulpitis recruited from Outpatient department of Pedodontics and Preventive Dentistry, PGIDS, Rohtak, Haryana.
Sample size: Total number of 72 patients will be recruited in this study, with 36 patients allocated to each group
Methods: The children will be positioned supine on dental chair and examined by the dental examiners using dental chair light and mouth mirrors. Use of cotton pellets to dry the teeth and wipe away gross debris. The teeth will be anesthetized using lidocaine 2% with epinephrine 1:80000 and isolated with rubber dam. Access to the pulp chamber will be obtained after the removal of caries and exposure of the vital pulp, using a high speed bur with a water spray. Subsequently, the coronal pulp tissue will be removed down to the canal orifices. The pulp chamber will be irrigated with a light flow of water from the water syringe and excavated. A sterile cotton pellet damped in sterile saline will be placed against the pulp stumps at orifices of the root canals. The bleeding from pulp stump will be evaluated regarding the color and hemostasis achieved within 25 minutes of pressure application. After hemostasis, the test material will be placed as per the study groups.
Group 1- After hemorrhage control , 1-1.5mm of TheraCal LC will be placed on the radicular pulp stumps followed by light curing, followed by the placement of IRM cement and composite restorative material after 2 weeks following the evaluation of postoperative signs and symptoms.
Group 2- After hemorrhage control , a small ball like consistency of 2-3mm of MTA will be placed on the radicular pulp stumps, followed by the placement of IRM and composite restorative material after 2 weeks following the evaluation of postoperative signs and symptoms.
All procedures will be performed in one visit and periapical radiographs will be obtained immediately after treatment. Standardization of the X-ray will be done to have reproducibility of the X-ray during the follow-up period for evaluating the periapical changes post treatment.
Outcome measures: Clinically asymptomatic and no new periapical pathology is formed post treatment.
Statistical analysis: The data collected for each group will be entered in Microsoft excel chart to prepare a master chart. The statistical analysis for the study will be done using SPSS (Statistical Package for the Social Sciences, inc., United States). To assess the effect of independent variable on outcome variables chi square test or fischer test exact shall be utilised along with correlation and regression equation. Statistical significance will be computed and p value_< 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theracal LC Pulpotomy | Experimental | Drug: Theracal LC36 children with the cariously exposed mature permanent molar teeth indicated for pulpotomy and fulfilling the inclusion criteria will be taken for the study and coronal pulpotomy will be done till the level of root canal orifice. |
| MTA Pulpotomy | Active comparator | Drug: MTA36 children with the cariously exposed mature permanent molar teeth indicated for pulpotomy and fulfilling the inclusion criteria will be taken for the study and coronal pulpotomy will be done till the level of root canal orifice. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Patient should be between 9-14 years of age
- Intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain
- Permanent molar tooth with deep caries and subsequent pulp bleeding evident upon excavation of caries.
- Rapid exposure to dramatic temperature changes elicited heightened and prolonged episodes of pain even after the thermal stimulus has been removed
- Vital bleeding pulp tissue should be present in all canals after complete pulpotomy
Key exclusion criteria (10 listed)
- Teeth with immature roots
- Non-restorable
- Pathological mobility
- Pus discharge through an associated sinus tract
- Swelling of associated tissues
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 |
|---|---|---|
| Theracal LCAlso: Resin-modified calcium silicateAfter hemorrhage control , 1-1.5mm of TheraCal LC will be placed on the radicular pulp stumps followed by light curing, followed by the placement of IRM and composite restorative material after 2 weeks | Drug | Theracal LC Pulpotomy |
| MTAAlso: Bioactive calcium silicateAfter hemorrhage control , a small ball like consistency of 2-3mm of MTA will be placed on the radicular pulp stumps, followed by the placement of IRM and composite restorative material after 2 weeks | Drug | MTA Pulpotomy |
Primary outcome
Clinical success rate
Time frame: Baseline to 12 months
Clinical success criteria : 1. No history of spontaneous pain or discomfort except for the first day after treatment 2. No tenderness to palpation or percussion and the tooth is functional 3. Normal mobility and probing pocket depth 4. Soft tissues around the tooth are normal with no swelling or sinus tract
Radiographic success rate
Time frame: Baseline to 12 months
Radiographic success criteria: 1. No pathosis evident on the radiograph such as root resorption, new furcal or periapical pathosis 2. No canal obliteration
2 secondary outcomes
Pain assessment
Time frame: Baseline to 7 days
Hemostasis duration
Time frame: Baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Vignesh R, MDS principal investigator
POST GRADUATE INSTITUTE OF DENTAL SCIENCES Rohtak,Haryana, India- 124001
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 Theracal LC and MTA in people with Irreversible Pulpitis and Deep Caries, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 Feb 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 India. 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?
Results are not available in the source record.
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 rate (time frame: Baseline to 12 months). The study lists 2 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 17 Feb 2023.