Extraction of the Compromised First Permanent Molars

Caries Clinical Trial

— FPM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231823
• Other study ID #: FDASU-RecIR012364
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 2027

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: Dina D Abdelmoneim, PhD
• Phone: 02 22639083
• Email: dinadarwish[@]dent.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: January 2027
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries
• Caries,Dental
• Dental Caries

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	El-Willi

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	radiographic spontaneous space closure	radiographically, using panoramic radiograph	3 years
Secondary	assessment of the Quality of life	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
Secondary	Midline shift	Investigate the midline shift by clinical examination.	3 years