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

NCT ID: NCT05867862

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-05-30

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

Detailed Description

Clef are congenital defects of the oral sphere; there are different types of cleft : regarding the cleft of the primary palate, the investigator can find the cleft lip's that are either uni ou bi laterals and can affect the nostrils and /or the alveolar bone; the clefs of the secondary palate are velar clefs, clefts of the palate or both meaning they affect the hard palate and soft palate.

Clefts accounts for 1 in 800 birth (1). 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.

A systemic revue looking for solutions or special therapy that could exists in order to optimized the oral health and dental status of cleft patient, conclude that there is a real necessity to maximized their treatment but few studies focus on preventive strategies or the development of tools to make OH easier for those patients.

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 investigatoir 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.

The main goal of this study is to 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 will be the evolution of the dental index, which is the DMF index (dmft/DMFT) There are numerous secondary objectives, that will result from the data driven analysis during the consultations, they will not lengthen the duration of the consultation and neither add extra interventions on the patient.

• Assess the contribution of the implementation of OH programs and regular dental follow-ups for children with clef and its effect on their gingival status.
• Assess the satisfaction of the dental care and the follow-ups by the patients and the parents.
• Assess the accessibility to dental care for children with cleft
• Assess the impact of familial eating and hygiene habits on OH and its evolution during the year of follow-up.
• Assess the influence of orthodontics appliance, syndromes and other conditions related to the cleft, malocclusion, bucco-nasal fistulas, dental anomalies, sweet medications and medication inducing hyposialie on tooth decay
• Assess preferential localization of tooth decay
• Assess the financial impact of this protocol

Children with a cleft lip and or palate uni ou bilateral, between the age of 3 and 15 years old, coming to the CCMR MAFACE for treatment will be offered the possibility to participate to this study.

If they accept, they will be randomly assigned to 2 different groups.

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 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 explanations will be provided as well as written ones. The goal is to have the best understanding of the importance of good OH and brushing technique from the children and the parents.

If dental treatments are needed, they will be done in the same time, or they will be programmed for another time at de the center of dental car of the hospital (CSD).

Patient in the test groups will also have tele-consultations every 2 months, in order to try and keep the child motivation to a maximum and also assess the OH of the patient, they will also have an extra consultation with the dentist at 6 months.

Regarding the primary objective, the 2 groups will have a carious record done at day 1, year 1 and year 2; the secondary objective will also be collected at those dates, and for the test groups extra data will be collected at 2 month, 4 month, 6 month, 8 month and 10 month.

The number of necessary subjects was calculated using two different studies using the same criteria of judgement, 54 patients are needed for this study, 27 in each group.

If the investigator can show a significant difference in the medical and dental care due to the implication of this program, the goal would be to generalize this course of treatment to all the children with cleft within the service of maxillar-surgery (CMF) in Nantes and then once it's a well-rounded system the investigators could implement this way of working nation wild.

On a local scale, this initiative and adding a regular dental consultation could allow the establishment of a day hospital for those patients, and therefore it would be more comfortable for the patients and the parents.

Conditions

Orofacial Cleft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Conventional dental care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Oral hygiene improvement

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.

Group Type: EXPERIMENTAL

Test

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nantes University Hospital

Nantes, Loire-Atlantique, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39789639 (View on PubMed)

Other Identifiers

RC22_0683

Identifier Type: -

Identifier Source: org_study_id