Risk of Caries and Enamel Abnormalities in Patients With Cleft Palate
NCT07926646, Not applicable, Not yet recruiting, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Risk of Caries and Enamel Abnormalities in Patients With Cleft Palate | ClinicalTrials.gov |
| NCT number | NCT07926646 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 400 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ClinicalTrials.gov |
| Conditions | Dental Caries | ClinicalTrials.gov |
| Interventions | Clinical oral examination and standardised questionnaires | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Caries experience assessed by the dmft/DMFT index in patients with cleft lip and/or palate compared with age-matched controls | Throughout the entire study, approximately during 20 months | 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. | ClinicalTrials.gov |
| Secondary | Prevalence of developmental defects of enamel in patients with cleft compared with controls | Throughout the entire study, approximately during 20 months | ClinicalTrials.gov | |
| Secondary | Localisation of developmental defects of enamel assessed by the modified DDE index in patients with cleft compared with controls | Throughout the entire study, approximately during 20 months | 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. | ClinicalTrials.gov |
| Secondary | 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) | Throughout the entire study, approximately during 20 months | 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. | ClinicalTrials.gov |
| Secondary | 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 | Throughout the entire study, approximately during 20 months | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)