Comparative Evaluation of Partial and Complete Pulpotomy in Mature Permanent Molars With Clinical Signs Indicative of Irreversible Pulpitis
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Clinical Success and radiographic success
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Complete Pulpotomy
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.
Intervention: Pulpotomy to the level of canal orifices (Procedure)
Partial Pulpotomy
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.
Intervention: Pulpotomy up to superficial 2-3 mm of pulp chamber (Procedure)
Outcomes
Primary Outcomes
Clinical Success and radiographic success
Time Frame: Baseline to 12 Months
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.
Secondary Outcomes
- Pain analysis(Baseline to 7 days)