NCT06517238 A New Digital Communication Tool Between Dentist and Orthodontist to Improve Dental Prevention
| NCT ID | NCT06517238 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Reims |
| Condition | Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 Years |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-01-01 with a primary completion date of 2029-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dentists and orthodontists of the oral medicine department of Reims University Hospital noted that many children presented white spots around orthodontic brackets, or decays at the end of their multi-brackets orthodontic treatment. These defects required dental cares and sometimes led to dental avulsions. These situations highlighted a poor oral hygiene of children (poorly done or insufficient dental brushing), a lack of oral prevention of their dentist and/or orthodontist, or even a lack of communication between these two practitioners. The objective of this study is to evaluate if a regular prevention and a specific communication between dentist and orthodontists could reduce the individual caries-risk of patients with multi-brackets orthodontic treatment. During all the orthodontic treatment, a semi-annual oral prevention consultation will be established for each patient, and a digital communication tool will be made available to dentists and orthodontists to facilitate their exchanges. The study population consists of children under 18 years-old when laying multi-brackets orthodontic treatment. The study population consists of children aged 8 to 18 years-old (at the start of treatment) treated with multi-brackets orthodontic treatment. The study population is divided in two groups: (i) a control group corresponding to children not benefiting from regular oral preventive follow up monitoring and completing their orthodontic treatment during the year in 2024; (ii) a study group composed of children starting their orthodontic treatment during the year in 2024 and benefiting from regular oral prevention every 6 months, up to four years. Several parameters will be evaluated from patient medical records: the caries index, the ICDAS score, the plaque index, the oral hygiene and food habits. Concerning the study group, a new digital communication tool will be made available to the dentist and the orthodontist to monitor the oral hygiene of patients. An evaluation of the oral hygiene will be done every 6 months. The expected outcomes of this study concern the interest of (i) a bi-annual prevention consultation to reduce caries risk, (ii) a regular communication between practitioners to adjust the orthodontic treatment according to the individual caries-risk. The expected hypothesis is to decrease the patient's caries and plaque indexes in the study group.
Eligibility Criteria
Inclusion criteria: Patients aged under 18 years old when laying treatment. They required multi-brackets orthodontic treatment in the oral medicine department of the Reims University Hospital Exclusion criteria: * children under 8 years old * Patients requiring other orthodontic treatment than multi-brackets, * Patients requiring any orthodontic treatment * disabled (with a loss of autonomy that don't allow proper brushing) * dental pathologies like amelogenesis imperfect, dentinogenesis imperfect, ectodermal dysplasia.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06517238 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 Years. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06517238 currently recruiting?
Yes, NCT06517238 is actively recruiting participants. Contact the research team at cguidez@chu-reims.fr for enrollment information.
Where is the NCT06517238 trial being conducted?
This trial is being conducted at Reims, France.
Who is sponsoring the NCT06517238 clinical trial?
NCT06517238 is sponsored by CHU de Reims. The trial plans to enroll 30 participants.