NCT06517238

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
43mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Jan 2024Dec 2029

First Submitted

Initial submission to the registry

December 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

July 24, 2024

Status Verified

April 1, 2024

Enrollment Period

5.9 years

First QC Date

December 18, 2023

Last Update Submit

July 18, 2024

Conditions

Keywords

Carious lesionsindividual caries-riskplaque indexpreventioncommunicationdentistorthodontistICDAS

Outcome Measures

Primary Outcomes (5)

  • Measure of DMFT index

    Number of Decayed, Missing due to caries, and Filled Teeth

    every 6 months, up to 4 years

  • Measure of plaque index (Silness and Loe)

    * Score 0 : absence of microbial plaque * Score 1 : film of bacterial plaque invisible to the naked eye; but thin film of microbial plaque along the free gingival margin collected with a probe * Score 2 : moderate accumulation with plaque in the sulcus visible to naked eye * Score 3 : large amount of plaque visible in sulcus or pocket along the free gingiva margin up to 2mm thick.

    every 6 months, up to 4 years

  • Modified Orthodontic Plaque index (MOP)

    * Score 0 : no plaque. * Score 1 : accumulation of mesial and/or distal plaque at the base of the attachment. * Score 2 : accumulation of mesial, distal, incisal and/or cervical plaque at the base of the attachment. * Score 3 : continuous plaque accumulation from the marginal gingiva to the base of the attachment. * Score 4 : complete coverage by the plaque.

    every 6 months, up to 4 years

  • Measure of ICDAS score

    * 0 No evidence of caries * 1 Initial caries * 2 Distinct visual change in enamel * 3 Localised enamel breakdown due to caries with no visible dentine * 4 Underlying dark shadow from dentine * 5 Distinct cavity with visible dentine * 6 Extensive distinct cavity with visible dentine

    every 6 months, up to 4 years

  • Socio-Professional Category

    * Farmers, * artisans, * traders and business leaders, * executives and higher intellectual professions, * intermediate professions, * employees, * workers

    Day 1

Secondary Outcomes (1)

  • Communication needed between dentist and orthodontist

    At 48 months

Study Arms (2)

Study group

Children starting a multi-brackets orthodontic treatment in the oral medicine department of University Hospital of Reims from January 2024. These childrens benefit from semi-annual appointment to analyze their oral health and their individual caries-risk by dentist. Moreover, these results will be communicated with a digital tool to orthodontist who can choose to adapt the orthodontic treatment of these childrens.

Other: There is no intervention

Control group

Other: There is no intervention

Interventions

Observal Study.There is no intervention

Control groupStudy group

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients were 8 and 18 years old

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

CommunicationDental Caries

Condition Hierarchy (Ancestors)

BehaviorTooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2023

First Posted

July 24, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

July 24, 2024

Record last verified: 2024-04

Locations