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

NCT05867862 | Completed

• 1 other identifier: RC22_0683
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cleft Lip with or without Cleft Palate; Oral hygiene

Outcome Measures

Primary Outcomes (1)

• DMF index : Assess the effects of the implementation of OH programs and regular dental follow-ups for children with clef and its effect on their OH status.

  The primary criteria of judgment is the evolution of the dental index, which is the DMF index (dmft/DMFT). The DMF index if the census of all decayed, missing of filled teeth for temporary and permanent teeth.

  1 year

Secondary Outcomes (22)

• Assess the contribution of the implementation of OH programs and regular dental follow-ups for children with clef and its effect on their gingival health using Silness and Loe index.

  1 year

• Assess the satisfaction of the dental care and the follow-ups received during this study by the patients and parents

  1 year

• Assess the accessibility of dental care for children with cleft

  1 year

• Assess the accessibility of dental care for children with cleft

  1 year

• Assess the accessibility of dental care for children with cleft

  1 year

Study Arms (2)

Conventional dental care

NO INTERVENTION

The instructions regarding OH given to the children and their parents will be the same than the one usually given by the maxilla-facial surgeons or the orthodontists during their annual follow-up visits. If the patients are in need of dental care, they will be encouraged to contact their dentist.

Oral hygiene improvement

EXPERIMENTAL

A dental consultation of 30 to 45 minutes will be added to the annual visit with a dentist. During this consultation the children will be incited to have a better OH, oral and written explanations will be provided. The goal is to have the best understanding of the importance of a good OH and brushing technique from the children and the parents. 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, in order to try and keep the child and parent motivation to a maximum and also assess the OH of the patient.

Other: Test

Interventions

Test OTHER

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

Oral hygiene improvement

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child between the age of 3 and 15 years of, affected with a cleft associated or not with other syndromes or disabilities, with a regular follow up in the service of maxilla-facial surgery
• Authorization to participate
• Possibility to have a translator if difficulties to communicate

You may not qualify if:

• Impossibility to understand information during more than one session
• Not in possession of social security
• Refusal to participate in the study

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

Related Publications (1)

• Boeffard C, Loin J, Clouet R, Gaudin A, Corre P, Prud'Homme T. Implementation of a program to strengthen oral hygiene in patient with cleft deformities: a prospective randomized controlled clinical trial. Trials. 2025 Jan 9;26(1):14. doi: 10.1186/s13063-024-08507-w.

  PMID: 39789639 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For the control group: the instructions regarding OH given to the children and their parents will be the same than the one usually given by the maxilla-facial surgeons or the orthodontists during their annual follow-up visits. If the patients are in need of dental care, they will be encouraged to contact their dentist. For the test group: a dental consultation of 30 to 45 minutes will be added to the annual visit with a dentist. During this consultation the children will be incited to have a better OH, oral and written explanations will be provided. The goal is to have the best understanding of the importance of a good OH and brushing technique from the children and the parents.

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: May 22, 2023
• Study Start: May 31, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: February 13, 2026

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)