Extraction of the Compromised First Permanent Molars

NCT06231823 | Active Not Recruiting

• 1 other identifier: FDASU-RecIR012364
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries; Caries,Dental

Keywords

first permanent molar; molar incisor hypo mineralization; dental extraction; space closure

Outcome Measures

Primary Outcomes (2)

• clinical spontaneous space closure

  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

  radiographically, using panoramic radiograph

  3 years

Secondary Outcomes (2)

• assessment of the Quality of life

  6 months

• Midline shift

  3 years

Study Arms (1)

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

EXPERIMENTAL

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

Other: Extraction

Interventions

Extraction OTHER

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

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

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, El-Willi, 1111, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dina D Abdelmoneim

  Ain Shams Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 30, 2024
• Study Start: January 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)