Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment

Study Overview
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Brief Summary
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The purpose of this study is to compare the Success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis.

Detailed Description
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After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, risks and benefits associated with the procedure will be explained and written informed consent will be taken from the patients. Study subjects will be randomly allocated to either Complete pulpotomy or Root canal treatment Group.

Official Title
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Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment in Teeth With Clinical Signs Indicative of Irreversible Pulpitis

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Procedure: Pulpotomy
* Procedure: root canal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mature permanent restorable mandibular molar teeth. Tooth should give positive response to pulp sensibility testing. Clinical diagnosis of irreversible pulpitis with PAI score≤2. Tooth with probing pocket depth and mobility are within normal limits. 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. Absence of antagonist tooth. Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis Had taken analgesic in past 3 days. Tooth with periapical lesion visible on radiograph

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulpotomy<br>complete pulpotomy will be done till the level of root canal orifice. | Procedure: Pulpotomy<br>* After achieving hemostasis, in pulpotomy group bioceramic material will be placed and then permanent restoration will be done.<br>|
| Active Comparator: Root canal treatment<br>Single visit root canal treatment will be done according to standard protocol. | Procedure: root canal treatment<br>* Single visit root canal treatment will be done according to standard protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rate | Clinical success criteria No history of spontaneous pain No tenderness to palpation or percussion Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract. | 6 months and one year | 
| Radiographic success rate | Radiographic success criteria No pathosis evident on the radiograph Periapical Index score 1 or 2 | 6 months and one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Health related quality of Life | Oral Health Impact Profile-14 questionnaire of score 0-4 will be used to assess the quality of life. Score 0 means never and 4 means very often affected the quality of life. | baseline to one week, 6 months and one year | 
| Pain assessment | Visual analogue Scale of 0 to 10 Centimetere line will be used to assess pain. Score 0 means no pain and Score 10 means maximum pain. | baseline to one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulpitis, pulpotomy, single visit root canal treatment, bioceramic material