Risk of Caries and Enamel Abnormalities in Patients With Cleft Palate

November 3, 2026 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
    • Brabant Flamand
      • Brussels, Brabant Flamand, Belgium, 1200
        • Cliniques universitaires Saint-Luc
        • Contact:
        • Contact:
          • Pierre Mahy, MD, DDS, PhD
        • Sub-Investigator:
          • Fanny Deghorain, DDS, MSc (Paediatric Dentistry
        • Principal Investigator:
          • Pierre Mahy, MD, DDS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Cleft group:

  • Children and adolescents aged 2 to 18 years
  • Any cleft phenotype (isolated cleft lip, isolated cleft palate, cleft lip and alveolus, cleft lip and palate), unilateral (left or right) or bilateral
  • With or without an associated syndrome
  • Primary and/or permanent teeth present
  • Followed at the Cleft Lip and Palate Centre of the Cliniques universitaires Saint-Luc

Control group:

  • Healthy children and adolescents aged 2 to 18 years
  • No cleft lip and/or palate
  • Followed at the Cliniques universitaires Saint-Luc (paediatric dentistry, routine annual check-up or consultation within the Institute of Dental Medicine and Stomatology - IMDS)
  • Primary and/or permanent teeth present

Exclusion Criteria:

Cleft group:

  • Edentulous patients (no teeth)

Control group:

  • Edentulous patients (no teeth)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cleft 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

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.
Other: Control group

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Caries experience assessed by the dmft/DMFT index in patients with cleft lip and/or palate compared with age-matched controls
Time Frame: 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.
Throughout the entire study, approximately during 20 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of developmental defects of enamel in patients with cleft compared with controls
Time Frame: Throughout the entire study, approximately during 20 months
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
Time Frame: 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.
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)
Time Frame: 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.
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
Time Frame: 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.
Throughout the entire study, approximately during 20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/13JUL/315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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