Extraction of the Compromised First Permanent Molars (FPM)

February 18, 2025 updated by: dina darwish, Ain Shams University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Willi
      • Cairo, El-Willi, Egypt, 1111
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Extraction
Simple / surgical dental extraction for necrotic. irreversible pulpitis, unrestorable, and first permanent molars with sever molar incisor hypomineralization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
radiographic spontaneous space closure
Time Frame: 3 years
radiographically, using panoramic radiograph
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of the Quality of life
Time Frame: 6 months
Measure the quality of life of the children before extraction and at 6 months follow-up using parent perception questionnaire and family impact scale (P-CPQ and FIS) and child perception questionnaire 8- 10 or 11-14 (CPQ 8-10; CPQ 11-14) according to the child's age.
6 months
Midline shift
Time Frame: 3 years
Investigate the midline shift by clinical examination.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Dina D Abdelmoneim, Ain Shams Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 27, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-RecIR012364

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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