NCT06006429

Brief Summary

Periodontal diseases and dental pathologies are highly prevalent oral diseases. Thirty-three to fifty percent of adult population presented at least one untreated caries and more than 50% of French population are affected by severe periodontitis. These diseases affect dental organ or periodontal attached system but could have negative impact on general health, quality of life, word and individual well-being. Association between chronic diseases as diabetes, rheumatoid arthritis, cardiovascular diseases, and oral health have been well investigated. Dental and periodontal diagnosis is dependent of various clinical parameters time consuming and dependent operator. It represents a public health challenge. Informatic analysis detecting diseases could be a time gain and a more precise diagnosis tool. Today, any software or algorithm allow automatized detection, clinical qualitative or quantitative indices recording while these informations are present in numeric models

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 not_applicable

Timeline
7mo left

Started May 2022

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
May 2022Dec 2026

Study Start

First participant enrolled

May 11, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2026

Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

4.6 years

First QC Date

August 17, 2023

Last Update Submit

April 24, 2024

Conditions

Keywords

Periodontal diseasesDental cariesintra-oral cameradiagnosis

Outcome Measures

Primary Outcomes (1)

  • Recession measurement concordance (Ramfjord, 1959)

    Recession depths is measured between the cementum-enamel junction and the edge of the marginal gingiva. The clinical and numerical scored will be compared.

    Day 1

Secondary Outcomes (5)

  • Dento-prosthetic diagram concordance

    Day 1

  • Plaque Control Record Concordance (O'Leary et al., 1972)

    Day 1

  • Gingival Index Concordance (Loe and Silness, 1963)

    Day 1

  • Decayed, Missed and Filled Teeth Index (Klein and Palmer, 1940)

    Day 1

  • Mucosal lesions detection

    Day 1

Study Arms (1)

Patients

EXPERIMENTAL
Other: Numerical dental impression by intraoral scanner

Interventions

Intervention consists in an 3D intra oral representation of the oral cavity

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adultes
  • consulting the Dental Care Service of the university hospital of Reims
  • presenting at least one gingival recession
  • presenting at least 10 pairs of opposing teeth
  • speaking French
  • who signed the informed consent form
  • affiliated to the French Social Security system

You may not qualify if:

  • Patients presenting :
  • pregnancy or breastfeeding
  • orthodontic treatments
  • patients under legal protection, trusteeship or guardianship
  • unable to understand auto-questionnary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

PeriodontitisGingivitisDental CariesDiseasePeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesTooth DemineralizationTooth DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

May 11, 2022

Primary Completion (Estimated)

December 11, 2026

Study Completion (Estimated)

December 11, 2026

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations