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Active, Not Recruiting

NCT Number: NCT06231823

Extraction of the Compromised First Permanent Molars

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, El-Willi, 1111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extraction

Other

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

Primary outcomes

  1. 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.

  2. radiographic spontaneous space closure

    Time frame: 3 years

    radiographically, using panoramic radiograph

Secondary outcomes

  1. 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.

  2. Midline shift

    Time frame: 3 years

    Investigate the midline shift by clinical examination.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: FPM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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