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Recruiting NCT06006429

Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools

No phase Interventional Periodontitis Gingivitis Dental Caries Diagnosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Numerical dental impression by intraoral scanner.
Who it may be relevant to
Registry conditions: Periodontitis, Gingivitis, Dental Caries, Diagnosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Digital Extraction and Scientific Visualization of Clinical Characteristics From 3D Data From Intraoral Scanners for Dental and Periodontal Pathologies Research : Computer Formalization and Feasibility Study

Overview

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

Detailed description

The present study explores the effectiveness of intraoral scanners in the field of dental caries and periodontal diseases diagnosis Patients presenting at least on recession are recruited without randomization. A clinical examination is performed, and a 3D impression of their mouth is obtained by intraoral scanners.

The investigators hypothesized that the 3D intra oral representations could improve oral diagnosis in patients compared to clinical examination in term of time consummation and precision. In a first time, this could be achieved by the comparison of the recession measurement obtained by a clinical measure (Ramfjord, 1959) or obtained by artificial intelligence.

The secondary objectives are :

* To compare clinical and numerical dento-prosthetic diagram * To compare clinical and numerical plaque control record index (O'Leary et al., 1973) * To compare clinical and numerical Decayed, Missed and Filled Teeth index (Klein and Palmer, 1940) * To compare clinical and numerical detection of mucosal lesions

Interventions

  • Other Numerical dental impression by intraoral scanner
    Intervention consists in an 3D intra oral representation of the oral cavity

Primary outcome measures

  • Recession measurement concordance (Ramfjord, 1959) [Time frame: Day 1]
Secondary outcome measures (5)
  • Dento-prosthetic diagram concordance [Time frame: Day 1]
  • Plaque Control Record Concordance (O'Leary et al., 1972) [Time frame: Day 1]
  • Gingival Index Concordance (Loe and Silness, 1963) [Time frame: Day 1]
  • Decayed, Missed and Filled Teeth Index (Klein and Palmer, 1940) [Time frame: Day 1]
  • Mucosal lesions detection [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

Patients presenting :

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • Damien JOLLY — Reims

Identifiers

NCT: NCT06006429 · PO21146

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗