Cleft lip and/or palate, affecting 1 in 800 births, is the most common congenital orofacial deformity. It impacts various structures including bones, soft tissues, and teeth, leading to challenges in eating, speaking, breathing, and hearing, alongside significant psychological and social implications. Research indicates that cleft patients exhibit lower levels of oral hygiene (OH) and dental health (DH), with higher rates of tooth caries and poorer periodontal health compared to their peers. Factors contributing to this include a focus on surgical reconstruction over dental care, anatomical challenges, and difficulties in accessing competent dental care.
A prospective, controlled, randomized study at the Nantes Cleft Centre aims to assess the impact of an enhanced personal dental program on OH and DH in cleft patients. The study will utilize the DMF (Decayed, Missing, Filled) and Silness and Loe indices to measure outcomes. Patients will be divided into control and test groups, with the latter receiving additional dental consultations, OH and dietary instructions, dental prophylaxis, and professional fluoride treatments. The study also plans to use telemedicine for follow-up and motivation reinforcement.
The primary objective is to evaluate the effect of the enhanced dental program on the OH status of cleft patients, with secondary objectives including assessing the impact on gingival status, caries localization, and the influence of orthodontic appliances and dietary habits on OH. The study will also evaluate patient and parent satisfaction with the dental care provided, the accessibility of dental care, and the financial implications of the program.
Recruitment targets patients aged 3 to 15 with cleft lip and/or palate, treated at the Nantes University Hospital. The study design includes a detailed consent process, data collection through electronic case report forms, and a comprehensive statistical analysis plan to evaluate the program's effectiveness. The study has received ethical approval and is registered at ClinicalTrials.gov (NCT05867862), highlighting its commitment to patient safety and data integrity.
