Comparative Evaluation of Partial and Complete Pulpotomy in Permanent Molars

Study Overview
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Brief Summary
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This study will compare the outcome of partial pulpotomy and complete pulpotomy in mature permanent molars with clinical signs indicative of irreversible pulpitis

Detailed Description
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After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be taken after explaining the procedure and its associated risks and benefits. Clinical diagnosis of irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. Once included, study subjects will be randomly allocated to either Complete Pulpotomy group or Partial Pulpotomy group. (Mineral Trioxide Aggregate) MTA will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in second appointment. Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at every 3 months from baseline to 1 year.

Official Title
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Comparative Evaluation of Partial and Complete Pulpotomy in Mature Permanent Molars With Clinical Signs Indicative of Irreversible Pulpitis

Conditions
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Pulpitis - Irreversible

Intervention / Treatment
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* Procedure: Pulpotomy to the level of canal orifices
* Procedure: Pulpotomy up to superficial 2-3 mm of pulp chamber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria The patient should be ≥18 years of age. Restorable molar teeth. Tooth should give positive response to pulp sensibility testing. Clinical diagnosis of irreversible pulpitis. Tooth with probing pocket depth and mobility are within normal limits. No signs of pulpal necrosis including sinus tract or swelling. Non-contributory medical history Exclusion Criteria: Teeth with immature roots. No pulp exposure after caries excavation. Bleeding could not be controlled in 6 minutes. Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Complete Pulpotomy<br>In case of complete pulpotomy procedure the exposed pulp tissue will be amputated using sterile bur in high speed hand piece to the level of canal orifices. | Procedure: Pulpotomy to the level of canal orifices<br>* Pulp tissue will be removed till the level of canal orifices.<br>|
| Active Comparator: Partial Pulpotomy<br>In case of partial pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece to a depth of 2-3 mm. | Procedure: Pulpotomy up to superficial 2-3 mm of pulp chamber<br>* Only superficial pulp from the chamber will be removed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success and radiographic success | CLINICAL SUCCESS CRITERIA: Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion. RADIOGRAPHIC SUCCESS CRITERIA: No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic et al. Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique. Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category. | Baseline to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain analysis | To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 10 Centimetere line. Score 0 means no pain and Score 10 means maximum pain. | Baseline to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vital Pulp Therapy, Partial Pulpotomy, Irreversible Pulpitis, Complete Pulpotomy