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Implementation of a Program to Strengthen Oral Hygiene in Patient With Cleft Deformities

NCT05867862 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-13

No results posted yet for this study

Summary

A thorough analysis of the literature shows that children with clefts have a lesser oral hygiene (OH) and dental health (DH) than children without facial malformations, which leads to an increased number of tooth decay on temporary and permanent tooth and a poor gingival health due to gingivitis or periodontitis. The incidence of tooth decay is corelated with the severity of the cleft, children with bilateral cleft lip (including the alveolar bone) have a higher rate of tooth decay. Despite the fact that carious lesions are decreasing in general population, its rate remain constant in children with cleft.

Children who suffer from cleft in the north-west region of France are treated within the center of competence of rare disorder in the Nantes's hospital (CCMR MAFACE); this center is a gathering of different professional health specialist (surgeon, speech specialist, gynecologist, orthodontists, pediatrician…) working together to maximize treatment for those patients from diagnosis (sometime antenatal) to adulthood.

The active file of patients treated for cleft in Nantes's CHU is quite important, allowing an easy recruitment.

The investigator would like to create a clinical study, assessing the impact implementing a special program to strengthen OH in patient with cleft whose follow-up is taking place in Nantes's CCMR MAFACE. It would be an epidemiologic, prospective, randomized, controlled, and monocentric study

Conditions

  • Orofacial Cleft

Interventions

OTHER

Test

A dental consultation of 30 to 45 minutes will be added to the annual visit with a dentist. If dental treatments are needed, they will be done at the same time, or they will be programmed for another time at the center of dental care (CSD). Due to the fact that most patient live far away from Nantes and the hospital, teleconsultation for patient in the test groups will happen every 2 months

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2024-05-30
Completion
2024-05-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05867862 on ClinicalTrials.gov