Меню
Идёт набор NCT06517238

A New Digital Communication Tool Between Dentist and Orthodontist to Improve Dental Prevention

Наблюдательное 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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: There is no intervention.
Кому может быть актуально
Состояния в реестре: 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. Базовые параметры: 8 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Development and Evaluation of a New Digital Communication Tool Between Dentists and Orthodontists to Improve Oral Prevention for Patients With Multi-bracket Treatment

Обзор

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.

Подробное описание

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

Вмешательства

  • Другое There is no intervention
    Observal Study.There is no intervention

Первичные конечные точки

  • Measure of DMFT index [Срок оценки: every 6 months, up to 4 years]
  • Measure of plaque index (Silness and Loe) [Срок оценки: every 6 months, up to 4 years]
  • Modified Orthodontic Plaque index (MOP) [Срок оценки: every 6 months, up to 4 years]
  • Measure of ICDAS score [Срок оценки: every 6 months, up to 4 years]
  • Socio-Professional Category [Срок оценки: Day 1]
Вторичные конечные точки (1)
  • Communication needed between dentist and orthodontist [Срок оценки: At 48 months]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Damien JOLLY — Reims

Идентификаторы

NCT: NCT06517238 · 2023Ao001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗