Clinical trial NCT06137391: Effectiveness of Pulpotomy in Carious First Permanent Molar
Official title: Effectiveness of Partial Pulpotomy and Pulpotomy in Symptomatic Deeply Carious Permanent First Molars With Molar Incisor Hypomineralisation (24 Months Randomised Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Molar Incisor Hypomineralization
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 96
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain assessment
timeFrame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
measure: Digitalized periapical Radiographs
timeFrame: Day 0, then at 6, 12, 18 and 24 months.
measure: Cone Beam Computed Tomography scans
timeFrame: Day 0, 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AlexU
name: Rodaina H. Helmy
role: PRINCIPAL_INVESTIGATOR
References: