Effectiveness of Pulpotomy in Carious First Permanent Molar
- Conditions
- Molar Incisor Hypomineralization
- Interventions
- Procedure: Vital Pulp Therapy
- Registration Number
- NCT06137391
- Lead Sponsor
- Alexandria University
- Brief Summary
Pediatric dentists frequently encounter deeply carious young permanent first molars (PFM) with Molar Incisor Hypomineralisation (MIH). Pulpal status of affected PFM was found to be different from that of unaffected PFMs which consequently might influence the pulpal response after vital pulp therapy.
The aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic PFM affected with MIH over 24 months.
- Detailed Description
Pediatric dentists frequently encounter deeply carious young permanent first molars (PFM) with Molar Incisor Hypomineralisation (MIH). Pulpal status of affected PFM was found to be different from that of unaffected PFMs which consequently might influence the pulpal response after vital pulp therapy. The aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic PFM affected with MIH over 24 months. In this prospective randomized controlled clinical trial, a randomized assigned sample of 96 children each with a deeply carious young PFM, Group I (n=48) diagnosed with MIH and irreversible pulpitis and Group II (n=48) diagnosed with irreversible pulpitis but not affected with MIH. Group I will be randomly equally allocated into Group II A (n=24): partial pulpotomy (PP) and Group I B (n=24): full pulpotomy (FP). Group II will also be randomly equally allocated into Group II A (n=24): PP and Group II B (n=24): FP. If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC). Teeth will be followed up clinically and radiographically using periapical x-rays for 24 months. Cone beam computed tomographic scans will be taken initially and at 24 months. Pain levels will be scored preoperatively before local anesthetic administration and postoperatively every 24 hours for 7 days using visual analogue scale. All data will be statistically analyzed and discussed considering the results obtained.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 7-13-year-old children.
- At least one deeply decayed first permanent molar, checked through periapical x-ray)
- Noncontributory medical history.
- The tooth should be showing irreversible pulpitis signs and symptoms.
- The tooth is restorable and probing pocket depth and mobility within normal limits.
- No signs of pulpal necrosis including sinus tract or swelling.
- Non-restorable teeth.
- Negative response to cold testing.
- Presence of sinus tract or swelling.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled after partial pulpotomy in 6 minutes.
- Insufficient bleeding after pulp exposure; the pulp is judged necrotic or partially necrotic.
- History of analgesic intake 3 days prior to the day of commencement of procedure.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No MIH with irreversible pulpitis Vital Pulp Therapy Group II (n=48) diagnosed with irreversible pulpitis but not affected with MIH. Group II will be randomly equally allocated into Group II A (n=24): partial pulpotomy (PP) and Group II B (n=24): full pulpotomy (FP). If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC). MIH and irreversible pulpitis Vital Pulp Therapy Group I (n=48) diagnosed with MIH and irreversible pulpitis. Group I will be randomly equally allocated into Group I A (n=24): partial pulpotomy (PP) and Group I B (n=24): full pulpotomy (FP). If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC).
- Primary Outcome Measures
Name Time Method Cone Beam Computed Tomography scans Day 0, 24 months Cone Beam Computed Tomography scans will be taken initially and at 24 months only to avoid excessive radiation dose
Pain assessment Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 Pain levels will be scored preoperatively before local anesthetic administration and postoperatively every 24 hours for 7 days using visual analogue scale, with 0 representing no pain and 100 representing pain as bad as it could be
Digitalized periapical Radiographs Day 0, then at 6, 12, 18 and 24 months. Standardized digitalized periapical radiographs will be taken.
- Secondary Outcome Measures
Name Time Method