Effectiveness of Pulpotomy in Carious First Permanent Molar

NCT06137391 | Unknown

• 1 other identifier: 0775-09/2023
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

MIH and irreversible pulpitis

EXPERIMENTAL

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

No MIH with irreversible pulpitis

ACTIVE COMPARATOR

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

Interventions

Vital Pulp Therapy PROCEDURE

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.

Also known as: Apexogenesis, Pulpotomy, Partial Pulpotomy

MIH and irreversible pulpitis; No MIH with irreversible pulpitis

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Apexification; Pulpotomy

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Root Canal Therapy; Endodontics; Dentistry

Study Officials

• Rodaina H. Helmy

  AlexU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodaina H. Helmy

CONTACT

+201100001193; rodaina.helmy@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Pediatric dentistry department, Faculty of dentistry

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share