Effectiveness of Pulpotomy in Carious First Permanent Molar

Molar Incisor Hypomineralization Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06137391
• Other study ID #: 0775-09/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Alexandria University
• Contact: Rodaina H. Helmy
• Phone: +201100001193
• Email: rodaina.helmy[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Procedure:
• Vital Pulp Therapy
The pulp is accessed after caries removal then the inflamed part of the pulp is excavated. After haemostasis is achieved, a pulpootmy medicament is used to coronally seal the remaining pulp tissue. In partial pulpotomy only part of the pulp chamber is excavated while in full pulpotomy the whole pulp chamber is excavated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	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	Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Primary	Digitalized periapical Radiographs	Standardized digitalized periapical radiographs will be taken.	Day 0, then at 6, 12, 18 and 24 months.
Primary	Cone Beam Computed Tomography scans	Cone Beam Computed Tomography scans will be taken initially and at 24 months only to avoid excessive radiation dose	Day 0, 24 months