Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 YearsComDentODFPrevNCT06517238
A New Digital Communication Tool Between Dentist and Orthodontist to Improve Dental Prevention
An observational study of Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 Years and DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 Years, DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Child, Adult
Study population: Patients were 8 and 18 years old
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Charline GUIDEZ, 03 26 78 77 11 ext. 0033, cguidez@chu-reims.fr
About this study
Official title: Development and Evaluation of a New Digital Communication Tool Between Dentists and Orthodontists to Improve Oral Prevention for Patients With Multi-bracket Treatment
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.
Read more
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.
Read the detailed description
The study population consists of children under 18 years-old when laying multi-brackets orthodontic treatment in the oral medicine department of Reims University Hospital. This population is distributed into 2 groups. The control group consists in children having completed their orthodontic treatment by December 2024, (n=30). The study group consists in children starting their orthodontic treatment during 2024 and benefiting from semi-annual oral prevention during four years-treatment. Moreover, their dentists and orthodontists will be able to access a digital communication tool to facilitate their exchanges. The number of patients in the study group will depend on the number of the patients in the control group.
The study protocol was approved by a regulatory agreement of the RGPD (register of processing activities) of Reims University Hospital since 14/11/23. All data will be anonymized. These data correspond to those that are systematically and usually collected by professionals during the orthodontic treatment. They will be stored in a secure computer located in the oral medicine department. The aim of the study and clinical procedures will be explained to the parents and the children to obtain their informed consent.
Data collected for control group at the treatment completion, an average of 4 years: put out the treatment:
- Sex: Girl/Boy/Non-Registered
- Date of birth (month/year) / age
- Processing end date
- Regular orthodontic appointment
- Socio-Professional Category (PCS 2020 level 1 nomenclature: 6 levels INSEE) : farmers; artisans, traders and business leaders; executives and higher intellectual professions; intermediate professions ; employees ; workers
- Decayed, missing and filled teeth index (DMFT Index)
- ICDAS score (International Caries Detection and Assessment System)
- Decays under dental restauration
- Modified orthodontic plaque index (MOP Index)
- Individual carious risk (based on HAS-France):
- Regular brushing
- Manual or electric brushing
- Presence of snacking and soda
- Taking long-term sweet or medication causing hyposialia
- Presence of dental plaque visualized by dental plaque disclosing tablet
- Presence of dental plaque visible without dental plaque disclosing tablet
- Presence of enamel demineralization
- Presence of caries lesions (dentin involvement) and/or reversible initial lesions (enamel involvement)
- Serrated grooves in molars
- Grooves treated by Sealent
- Fluoride varnish
- Presence of gingival hyperplasia
Data collected for study group during each consultation before the orthodontic treatment and followed every 6 months, up to 4 years:
- Appointment date
- Sex: Girl/Boy/Non-Registered
- Date of birth (month/year) / age
- Regular follow-up with a dentist
- Socio-Professional Category (PCS 2020 level 1 nomenclature: 6 levels INSEE) : farmers; artisans, traders and business leaders; executives and higher intellectual professions; intermediate professions ; employees ; workers
- Decayed, missing and filled teeth index (DMFT Index)
- ICDAS score (International Caries Detection and Assessment System)
- Plaque Index Silness et Loe before treatment
- Modified orthodontic plaque index (MOP Index) as soon as the treatment is applied
- Molar Incisor Hypomineralization (MIH): degree of severity (moderate - severe), type of teeth affected (molars - incisors), number of teeth treated
- Amelar abnormality: incisal dysplasia, number of teeth treated
- Individual carious risk (based on HAS-France):
- Regular brushing
- Manual or electric brushing
- Presence of snacking and soda
- Taking long-term sweet or medication causing hyposialia
- Presence of dental plaque visualized by dental plaque disclosing tablet
- Presence of dental plaque visible without dental plaque disclosing tablet
- Presence of enamel demineralization
- Presence of caries lesions (dentin involvement) and/or reversible initial lesions (enamel involvement)
- Serrated grooves in molars
- Grooves treated by Sealent
- Fluoride varnish
- Presence of gingival hyperplasia
- Need for prevention and/or care sessions
- Conditions
- Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 Years, DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist
- Being tested
- There is no intervention
- Keywords
- Carious lesions, individual caries-risk, plaque index, prevention, communication, dentist, orthodontist, ICDAS
- Medical subject headings
- Communication, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
Observal Study.There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: There is no intervention | |
| Control group | Not described Receives: Other: There is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of DMFT index
Number of Decayed, Missing due to caries, and Filled Teeth
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 1
Secondary outcomes (1)
Communication needed between dentist and orthodontist
focus group of dentist and orthodontist at the beginning and at the end of the study
Measured: At 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Jan 2024
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 YearsStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517238
- Sponsor's protocol ID
- 2023Ao001
- Acronym
- ComDentODFPrev
- Status last verified
- Apr 2024
- First submitted
- 18 Dec 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a New Digital Communication Tool Between Dentists and Orthodontists to Improve Oral Prevention for Patients With Multi-bracket Treatment
- ClinicalTrials.gov ID
- NCT06517238
- Acronym / sponsor ID
- ComDentODFPrev / 2023Ao001
- Conditions
- Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 Years, DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist
- Keywords
- Carious lesions, individual caries-risk, plaque index, prevention, communication, dentist, orthodontist, ICDAS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study population consists of children under 18 years-old when laying multi-brackets orthodontic treatment in the oral medicine department of Reims University Hospital. This population is distributed into 2 groups. The control group consists in children having completed their orthodontic treatment by December 2024, (n=30). The study group consists in children starting their orthodontic treatment during 2024 and benefiting from semi-annual oral prevention during four years-treatment. Moreover, their dentists and orthodontists will be able to access a digital communication tool to facilitate their exchanges. The number of patients in the study group will depend on the number of the patients in the control group.
The study protocol was approved by a regulatory agreement of the RGPD (register of processing activities) of Reims University Hospital since 14/11/23. All data will be anonymized. These data correspond to those that are systematically and usually collected by professionals during the orthodontic treatment. They will be stored in a secure computer located in the oral medicine department. The aim of the study and clinical procedures will be explained to the parents and the children to obtain their informed consent.
Data collected for control group at the treatment completion, an average of 4 years: put out the treatment:
- Sex: Girl/Boy/Non-Registered
- Date of birth (month/year) / age
- Processing end date
- Regular orthodontic appointment
- Socio-Professional Category (PCS 2020 level 1 nomenclature: 6 levels INSEE) : farmers; artisans, traders and business leaders; executives and higher intellectual professions; intermediate professions ; employees ; workers
- Decayed, missing and filled teeth index (DMFT Index)
- ICDAS score (International Caries Detection and Assessment System)
- Decays under dental restauration
- Modified orthodontic plaque index (MOP Index)
- Individual carious risk (based on HAS-France):
- Regular brushing
- Manual or electric brushing
- Presence of snacking and soda
- Taking long-term sweet or medication causing hyposialia
- Presence of dental plaque visualized by dental plaque disclosing tablet
- Presence of dental plaque visible without dental plaque disclosing tablet
- Presence of enamel demineralization
- Presence of caries lesions (dentin involvement) and/or reversible initial lesions (enamel involvement)
- Serrated grooves in molars
- Grooves treated by Sealent
- Fluoride varnish
- Presence of gingival hyperplasia
Data collected for study group during each consultation before the orthodontic treatment and followed every 6 months, up to 4 years:
- Appointment date
- Sex: Girl/Boy/Non-Registered
- Date of birth (month/year) / age
- Regular follow-up with a dentist
- Socio-Professional Category (PCS 2020 level 1 nomenclature: 6 levels INSEE) : farmers; artisans, traders and business leaders; executives and higher intellectual professions; intermediate professions ; employees ; workers
- Decayed, missing and filled teeth index (DMFT Index)
- ICDAS score (International Caries Detection and Assessment System)
- Plaque Index Silness et Loe before treatment
- Modified orthodontic plaque index (MOP Index) as soon as the treatment is applied
- Molar Incisor Hypomineralization (MIH): degree of severity (moderate - severe), type of teeth affected (molars - incisors), number of teeth treated
- Amelar abnormality: incisal dysplasia, number of teeth treated
- Individual carious risk (based on HAS-France):
- Regular brushing
- Manual or electric brushing
- Presence of snacking and soda
- Taking long-term sweet or medication causing hyposialia
- Presence of dental plaque visualized by dental plaque disclosing tablet
- Presence of dental plaque visible without dental plaque disclosing tablet
- Presence of enamel demineralization
- Presence of caries lesions (dentin involvement) and/or reversible initial lesions (enamel involvement)
- Serrated grooves in molars
- Grooves treated by Sealent
- Fluoride varnish
- Presence of gingival hyperplasia
- Need for prevention and/or care sessions
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: There is no interventionChildren 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. |
| Control group | – | Other: There is no intervention |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients were 8 and 18 years old
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no interventionObserval Study.There is no intervention | Other | Control group, Study group |
Primary outcome
Measure of DMFT index
Time frame: every 6 months, up to 4 years
Number of Decayed, Missing due to caries, and Filled Teeth
Measure of plaque index (Silness and Loe)
Time frame: every 6 months, up to 4 years
* 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.
Modified Orthodontic Plaque index (MOP)
Time frame: every 6 months, up to 4 years
* 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.
Measure of ICDAS score
Time frame: every 6 months, up to 4 years
* 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
Socio-Professional Category
Time frame: Day 1
* Farmers, * artisans, * traders and business leaders, * executives and higher intellectual professions, * intermediate professions, * employees, * workers
1 secondary outcome
Communication needed between dentist and orthodontist
Time frame: At 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 Years and DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charline GUIDEZ (03 26 78 77 11 ext. 0033, cguidez@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of DMFT index (time frame: every 6 months, up to 4 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.