An interventional study of Clinical oral examination and standardised questionnaires in Dental Caries, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Not yet recruiting at 1 site in Belgium. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Prevention
The goal of this interventional (non-drug, non-device) clinical study is to learn whether children and adolescents born with a cleft lip and/or palate have more tooth decay (dental caries) and more defects of the tooth enamel than children without a cleft, and whether these problems are linked to the type of cleft and to the surgeries these patients have received. In other words, the study aims to find out whether children whose cleft involves the lip and/or the alveolus (the tooth-bearing part of the upper jaw) have a higher risk of caries in the front teeth of the upper jaw.
The main questions it aims to answer are:
Do children with a cleft have a higher caries experience and a higher caries risk than children of the same age without a cleft? In other words, do children with a cleft involving the lip and/or the alveolus have a higher caries risk in the upper front (maxillary anterior) teeth? Are enamel defects (such as hypomineralisation or hypoplasia) more frequent in children with a cleft, where in the mouth are they mainly located, and are they associated with the cleft type or with specific surgical procedures? Do factors such as parental education level, eating habits, oral hygiene habits and the mobility of the scarred upper lip influence the number and the location of caries lesions? Researchers will compare about 200 patients aged 2 to 18 years with any type of cleft (isolated cleft lip, isolated cleft palate, or cleft lip and alveolus with or without cleft palate; with or without an associated syndrome), followed at the Cleft Lip and Palate Centre of the Cliniques universitaires Saint-Luc (Brussels, Belgium), with about 200 children and adolescents of the same age (plus or minus 1 year) without a cleft or syndrome, seen for a routine visit in the paediatric dentistry department of the same hospital.
No drug, device or treatment is tested, and participants' usual care will not be changed. The study adds standardised questionnaires and study-specific clinical assessments to a dental visit that is already planned as part of their regular follow-up. During this visit, participants will:
Have a standard oral examination to record decayed D, missing M and filled F teeth T (DMFT index) in primary and permanent teeth; Have their teeth screened for enamel defects using a standardised European method ( Developmental Defects of Enamel Index ); Have the mobility of their upper lip assessed with a clinical scale (cleft group only), because surgical scars can make brushing of the front teeth more difficult; Possibly have intra-oral photographs taken to document the findings (dental X-rays are only taken if clinically needed for their usual care, never for the study alone).
Parents or legal guardians will fill in short questionnaires about the child's medical and dental history, oral hygiene and eating habits, exposure to protective and risk factors for caries (CAMBRA Caries Management by Risk Assessment), and early-life factors that may be associated with enamel defects.
Participation takes place in a single visit and does not require any additional appointment. There is no direct individual benefit for participants, and the risks are minimal because only routine examinations and questionnaires are used. The results are expected to help identify children with a cleft who are at high risk of caries early on, to show which teeth are most vulnerable, and to design prevention strategies better adapted to these patients (for example, oral hygiene advice and tools adapted to the scarred upper lip).
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.
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Cleft group:
Control group:
Exclusion Criteria:
Cleft group:
Control group:
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.
Other: Clinical oral examination and standardised questionnaires
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.
Other: Clinical oral examination and standardised questionnaires
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 assessed by the dmft/DMFT index in patients with cleft lip and/or palate compared with age-matched controls
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.
Time frame: Throughout the entire study, approximately during 20 months
Prevalence of developmental defects of enamel in patients with cleft compared with controls
Time frame: Throughout the entire study, approximately during 20 months
Localisation of developmental defects of enamel assessed by the modified DDE index in patients with cleft compared with 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.
Time frame: Throughout the entire study, approximately during 20 months
Correlation between dietary, oral hygiene and socio-economic factors assessed by the CAMBRA form (Caries Management by Risk Assessment) and caries experience (dmft/DMFT index)
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.
Time frame: Throughout the entire study, approximately during 20 months
Correlation between upper lip mobility (clinical eversion score 0-3 and photographic lip mobility in mm) and anterior caries experience (dmft/DMFT index) in patients with cleft
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.
Time frame: Throughout the entire study, approximately during 20 months
Plan to share: No
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Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 12 months is below that.
Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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