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RecruitingNCT06006429Odonto3DUpdated Jun 12, 2026

Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools

An interventional study of Numerical dental impression by intraoral scanner in Periodontitis, Gingivitis and Dental Caries, sponsored by CHU de Reims. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by CHU de Reims · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled May 2022, registered Aug 2023).
  • Started May 2022; still recruiting 4 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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
02

Conditions studied

  • Periodontitis
  • Gingivitis
  • Dental Caries
  • Diagnosis

Keywords

  • Periodontal diseases
  • Dental caries
  • intra-oral camera
  • diagnosis
03

In context

Periodontitis

1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

This study's planned enrollment of 30 is below the median of 44 across 846 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

CHU de Reims is the lead sponsor of 276 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form
  • affiliated to the French Social Security system

Exclusion criteria

Exclusion Criteria:

Patients presenting :

  • pregnancy or breastfeeding
  • orthodontic treatments
  • patients under legal protection, trusteeship or guardianship
  • unable to understand auto-questionnary
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Patients

    Other: Numerical dental impression by intraoral scanner

Interventions

  • OtherNumerical dental impression by intraoral scanner

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

06

What researchers measure

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.

    Time frame: Day 1

Secondary outcomes

  1. Dento-prosthetic diagram concordance

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

    Time frame: Day 1

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

    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.

    Time frame: Day 1

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

    Gingival index is scored as described : 0 Normal gingival Natural coral pink gingival with no inflammation 1. Mild inflammation Slight changes in color, slight edema. No bleeding on probing 2. Moderate inflammation Redness, edema and glazing Bleeding under probing 3. Severe inflammation Marked redness and edema/ulceration Tendency to bleed spontaneously The clinical and numerical scored will be compared.

    Time frame: Day 1

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

    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.

    Time frame: Day 1

  5. Mucosal lesions detection

    Presence or absence of mucosal lesions. The clinical and numerical lesions will be compared.

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06006429
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Aug 23, 2023
Start date
May 11, 2022
Primary completion
Dec 11, 2027 (estimated)
Completion
Dec 11, 2027 (estimated)
Last update
Jun 12, 2026

Study contacts

Julien BRAUX
Contact
jbraux@chu-reims.fr
03 26 78 78 24 ext. 0033

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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