Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517238
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-12-18
Brief Title:
A New Digital Communication Tool Between Dentist and Orthodontist to Improve Dental Prevention
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ComDentODFPrev
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 andor 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 patients caries and plaque indexes in the study group
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 patients 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 n30 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 141123 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 GirlBoyNon-Registered
Date of birth monthyear 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 andor 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 GirlBoyNon-Registered
Date of birth monthyear 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 andor reversible initial lesions enamel involvement
Serrated grooves in molars
Grooves treated by Sealent
Fluoride varnish
Presence of gingival hyperplasia
Need for prevention andor care sessions
The study protocol was approved by a regulatory agreement of the RGPD register of processing activities of Reims University Hospital since 141123 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 GirlBoyNon-Registered
Date of birth monthyear 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 andor 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 GirlBoyNon-Registered
Date of birth monthyear 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 andor reversible initial lesions enamel involvement
Serrated grooves in molars
Grooves treated by Sealent
Fluoride varnish
Presence of gingival hyperplasia
Need for prevention andor care sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None