Risk of Caries and Enamel Abnormalities in Patients With Cleft Palate

Children and adolescents aged 2 to 18 years with any type of cleft lip and/or palate (with or without an associated syndrome), followed at the Cleft Lip and Palate Centre of the Cliniques universitaires Saint-Luc.

Single study visit during a routine dental consultation (standard of care), with study-specific standardised assessments: caries experience (dmft/DMFT, recorded tooth by tooth Decayed, Missing, Filled Teeth), enamel defect screening (Ghanim et al. 2015, modified DDE Developmental Defects of Enamel index), and CAMBRA (Caries Management by Risk Assessment). Parents complete standardised questionnaires on the child's medical and dental history, oral hygiene and dietary habits, and early-life factors associated with enamel defects. In the cleft group only, upper lip mobility is assessed with a clinical scale. Intra-oral photographs may be taken. No drug, device or treatment is tested, and no radiographs are taken for study purposes only.

Children and adolescents aged 2 to 18 years without a cleft or syndrome, age-matched (± 1 year) to the cleft group, seen for a routine visit in paediatric dentistry at the Cliniques universitaires Saint-Luc.

Single study visit during a routine dental consultation (standard of care), with study-specific standardised assessments: caries experience (dmft/DMFT, recorded tooth by tooth Decayed, Missing, Filled Teeth), enamel defect screening (Ghanim et al. 2015, modified DDE Developmental Defects of Enamel index), and CAMBRA (Caries Management by Risk Assessment). Parents complete standardised questionnaires on the child's medical and dental history, oral hygiene and dietary habits, and early-life factors associated with enamel defects. In the cleft group only, upper lip mobility is assessed with a clinical scale. Intra-oral photographs may be taken. No drug, device or treatment is tested, and no radiographs are taken for study purposes only.

Caries experience will be assessed by clinical oral examination by a calibrated examiner using the dmft index (decayed, missing and filled primary teeth) and/or the DMFT index (Decayed, Missing and Filled permanent Teeth), according to WHO diagnostic criteria. Scores range from 0 to 20 for dmft and from 0 to 28/32 for DMFT. Higher scores indicate greater caries experience. Mean scores will be compared between children with cleft lip and/or palate and age-matched controls.

Developmental defects of enamel will be recorded by clinical oral examination by a calibrated examiner using the MIH/HSPM long recording sheet (Ghanim et al., 2015), which includes MIH/HSPM and modified DDE characteristics on all erupted teeth. For each tooth and surface (buccal, occlusal/incisal, palatal/lingual), the defect type will be scored from 0 to 7 (0 = no defect; 1 = non-MIH/HSPM defect: diffuse opacity, hypoplasia, amelogenesis imperfecta, hypomineralisation; 2 = demarcated opacity; 3 = post-eruptive enamel breakdown; 4 = atypical restoration; 5 = atypical caries; 6 = missing due to MIH/HSPM; 7 = cannot be scored). Lesion extent will be graded I to III (<1/3, 1/3-2/3, ≥2/3 of the surface). Severity will be classified as mild or severe according to EAPD criteria. The distribution of defects by tooth, surface and cleft side will be compared between groups.

Risk factors will be recorded using the French version of the CAMBRA caries risk assessment form (Doméjean et al., 2025), age-specific version (0-6 years or >6 years). Each item is scored as present/absent (yes/no): dietary factors (frequent snacking >3 times/day; bottle or cup with liquids other than water, 0-6 y), oral hygiene factors (fluoride toothpaste at least twice daily; visible dental plaque) and socio-economic factor (low family socio-economic status and/or low health literacy, 0-6 y). Caries experience will be measured as dmft/DMFT score.

Upper lip mobility will be assessed in the cleft group by two methods: (1) a clinical eversion score from 0 to 3 (0 = normal mobility, full access to labial surfaces of maxillary anterior teeth; 1 = slightly reduced; 2 = moderately reduced, cervical third of incisors hardly accessible; 3 = severely reduced, tense lip, labial surfaces hardly accessible to brushing) (2) standardised peri-oral photographs at rest and at maximal smile, with lip mobility calculated as the difference in incisal exposure (smile minus rest, in mm). Anterior caries experience will be measured as the dmft/DMFT score of maxillary anterior teeth.