Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis

Study Overview
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Brief Summary
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This study will compare the outcome of partial and miniature pulpotomy in mature permanent molars with symptomatic partial irreversible pulpitis

Detailed Description
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After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, written informed consent will be obtained from study participants after explaining the procedure and its associated risks and benefits. Clinical diagnosis of symptomatic partial 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 Miniature Pulpotomy group or Partial Pulpotomy group. MTA (Mineral Trioxide Aggregate) 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 same 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 clinical and radiographic success at 6 and 12 months from baseline.

Official Title
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Outcome Comparing Partial and Miniature Pulpotomy in Mature Permanent Molars With Symptomatic Partial Irreversible Pulpitis

Conditions
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Pulpitis - Irreversible

Intervention / Treatment
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* Procedure: Partial pulpotomy
* Procedure: Miniature pulpotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient with18 -45 years of age. Restorable molar teeth. Tooth should give positive response to pulp sensibility testing. Clinical diagnosis of symptomatic partial 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: 45 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: Partial pulpotomy<br>Removal of superficial 2-3 mm of pulp tissue from entire pulp chamber | Procedure: 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 with water coolant to a depth of superficial 2-3 mm of pulp chamber.<br>|
| Active Comparator: Miniature pulpotomy<br>Removal of superficial 2-3 mm of pulp tissue from only affected pulp horn | Procedure: Miniature pulpotomy<br>* In case of miniature pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece with water coolant to a depth of superficial 2-3 mm of only affected pulp horn<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and radiographic success | 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 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain | Baseline to 7 days | 
| Pulp sensibility testing | To assess pulp tissue response using cold and electric pulp test at 6 and 12 months | Baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irreversible pulpitis, Partial pulpotomy, Miniature pulpotomy, Vital pulp therapy