Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

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

NCT06517238 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-01-01
Last updated
2024-07-24

Condition(s) studied

Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 YearsDMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist

Investigational drug(s) / intervention(s)

There is no intervention

There is no intervention: Observal Study.There is no intervention

Study 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

Sex
ALL
Min age
8 Years
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Measure of DMFT index — every 6 months, up to 4 years
    Number of Decayed, Missing due to caries, and Filled Teeth
  • Measure of plaque index (Silness and Loe) — 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) — 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 — 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 — Day 1
    * Farmers, * artisans, * traders and business leaders, * executives and higher intellectual professions, * intermediate professions, * employees, * workers

Trial sites (1)

FacilityCityRegionStatus
Damien JOLLY Reims France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06517238 on ClinicalTrials.gov ↗ ← All trials in France