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NCT Number: NCT06006429

Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools

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

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Key information

Conditions

Periodontitis Dental Caries Diagnosis Disease Gingival Diseases Gingivitis Infections Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Numerical dental impression by intraoral scanner

Other

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

Primary outcomes

  1. Recession measurement concordance (Ramfjord, 1959)

    Time frame: Day 1

    Recession depths is measured between the cementum-enamel junction and the edge of the marginal gingiva.

    The clinical and numerical scored will be compared.

Secondary outcomes

  1. Dento-prosthetic diagram concordance

    Time frame: Day 1

    Recording the presence or absence of tooth The clinical and numerical scored will be compared.

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

    Time frame: Day 1

    Plaque control record will be recorded on individual tooth surfaces (mesial, distal, facial, lingual).

    PCR is calculated according the following formula :

    PCR = (Number of faces with plaque / Total number of faces) x 100

    The clinical and numerical scored will be compared.

  3. Gingival Index Concordance (Loe and Silness, 1963)

    Time frame: Day 1

    Gingival index is scored as described :

    0 Normal gingival Natural coral pink gingival with no inflammation

    • Mild inflammation Slight changes in color, slight edema. No bleeding on probing
    • Moderate inflammation Redness, edema and glazing Bleeding under probing
    • Severe inflammation Marked redness and edema/ulceration Tendency to bleed spontaneously

    The clinical and numerical scored will be compared.

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

    Time frame: Day 1

    DMFT is the sum of decayed, missed due to caries and filled teech in the permanent teeth.

    Third molars are excepted.

    The clinical and numerical scored will be compared.

  5. Mucosal lesions detection

    Time frame: Day 1

    Presence or absence of mucosal lesions.

    The clinical and numerical lesions will be compared.

Study contacts

Contact information is provided by the study sponsor or research team.

Julien BRAUX

CONTACT

[email protected]

03 26 78 78 24 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study 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

Acronym: Odonto3D

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 23, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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