Effectiveness of Pulpotomy in Carious First Permanent Molar

Effectiveness of Partial Pulpotomy and Pulpotomy in Symptomatic Deeply Carious Permanent First Molars With Molar Incisor Hypomineralisation (24 Months Randomised Controlled Clinical Trial)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Procedure: Vital Pulp Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodaina H. Helmy; Phone Number: +201100001193; Email: rodaina.helmy@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIH and irreversible pulpitis; 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).	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.; Other Names: Apexogenesis, Pulpotomy, Partial Pulpotomy
Active Comparator: No MIH with irreversible pulpitis; 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).	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.; Other Names: Apexogenesis, Pulpotomy, Partial Pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Digitalized periapical Radiographs	Standardized digitalized periapical radiographs will be taken.	Day 0, then at 6, 12, 18 and 24 months.
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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Rodaina H. Helmy, AlexU

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Dental Enamel Hypoplasia; Molar Hypomineralization
• Other Study ID Numbers: 0775-09/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No