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Clinical Trials/NCT06231823
NCT06231823
Active, not recruiting
Not Applicable

The Extraction of Compromised First Permanent Molars in a Group of Egyptian Children

Ain Shams University1 site in 1 country37 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caries
Sponsor
Ain Shams University
Enrollment
37
Locations
1
Primary Endpoint
clinical spontaneous space closure
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
March 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

dina darwish

lecturer

Ain Shams University

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.

Outcomes

Primary Outcomes

clinical spontaneous space closure

Time Frame: 3 years

Clinically, using periodontal probe measure the amount of space between the distal surface of second premolar and mesial surface of second permanent molar.

radiographic spontaneous space closure

Time Frame: 3 years

radiographically, using panoramic radiograph

Secondary Outcomes

  • assessment of the Quality of life(6 months)
  • Midline shift(3 years)

Study Sites (1)

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