Extraction of the Compromised First Permanent Molars

NCT ID: NCT06231823

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-03-31

Brief Summary

Compromised first permanent molars (FPM), whether diagnosed with severe molar incisor hypomineralization (MIH), irreversible pulpities, or necrosis, require frequent re-treatment consequently entering the restorative cycle, which leads to their inevitable extraction and implant placement. Extraction of compromised first permanent molars in 8-10-year-old children allows the mesial migration of the second permanent molars during their eruption, thereby favoring spontaneous space closure as a permanent solution.

Detailed Description

Extraction of compromised first permanent molars in children decreases the burden of repeated restorative procedures for theses molars, which will eventually need frequent repair. This will end in their inevitable extraction with its consequences. The extraction of the FPM will be delivered by Nour Wahba, Dina Darwish, and Basma Nagi, lecturers in Pediatric Dentistry and Dental Public Health Department, faculty of Dentistry, Ain Shams University.All patients will be recalled for follow-up yearly for three-years. The first follow-up will be done after 6months to perform the Quality of life questionnaires. The position of the second permanent molar will be checked clinically and radiographically to evaluate the space between second premolar and the second molar.

Conditions

Caries; Caries,Dental

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

extraction of the compromised first permanent molars at 8-10 years children

extraction of badly decayed FPM at the E,F developmental stages of the second permanent molar.

Group Type: EXPERIMENTAL

Extraction

Intervention Type: OTHER

Simple / surgical dental extraction for necrotic. irreversible pulpitis, unrestorable, and first permanent molars with sever molar incisor hypomineralization.

Interventions

Extraction

Simple / surgical dental extraction for necrotic. irreversible pulpitis, unrestorable, and first permanent molars with sever molar incisor hypomineralization.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy patients' class I according to the American Society of Anesthesiologists (ASA class I)
• Age: 8-10 years
• Angle class I occlusion
• The radiographic presence of the second premolar
• The radiographic stages of development E or F for formation the second permanent molar.
• First permanent molar that is severely affected by MIH, signs of necrosis, signs of irreversible pulpitis or non-restorability.

Exclusion Criteria

• Refusal of the parents to sign the informed consent.
• Signs of reversible pulpitis of first permanent molar.
• Patients with severe malocclusion.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

dina darwish

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina D Abdelmoneim

Role: PRINCIPAL_INVESTIGATOR

Ain Shams Univeristy

Locations

Ain Shams University

Cairo, El-Willi, Egypt

Countries

Egypt

Other Identifiers

FDASU-RecIR012364

Identifier Type: -

Identifier Source: org_study_id