Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment in Teeth With Clinical Signs Indicative of Irreversible Pulpitis
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Radiographic success rate
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
outcome assessor will be blinded
Eligibility Criteria
- Ages
- 14 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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≤
- •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
Arms & Interventions
Pulpotomy
complete pulpotomy will be done till the level of root canal orifice.
Intervention: Pulpotomy (Procedure)
Root canal treatment
Single visit root canal treatment will be done according to standard protocol.
Intervention: root canal treatment (Procedure)
Outcomes
Primary Outcomes
Radiographic success rate
Time Frame: 6 months and one year
Radiographic success criteria No pathosis evident on the radiograph Periapical Index score 1 or 2
Clinical success rate
Time Frame: 6 months and one year
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.
Secondary Outcomes
- Pain assessment(baseline to one week)
- Oral Health related quality of Life(baseline to one week, 6 months and one year)
Investigators
Sanjay Tewari
Principal
Postgraduate Institute of Dental Sciences Rohtak