PeriodontitisOdonto3DNCT06006429
Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools
A study testing Numerical dental impression by intraoral scanner in people with Periodontitis and Gingivitis, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis, Dental Caries
- What is being tested?
- Numerical dental impression by intraoral scanner
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2022to 11 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients presenting :
- pregnancy or breastfeeding
- orthodontic treatments
- patients under legal protection, trusteeship or guardianship
- unable to understand auto-questionnary
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Julien BRAUX, 03 26 78 78 24 ext. 0033, jbraux@chu-reims.fr
About this study
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
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
- Conditions
- Periodontitis, Gingivitis, Dental Caries, Diagnosis
- Being tested
- Numerical dental impression by intraoral scanner
- Keywords
- Periodontal diseases, Dental caries, intra-oral camera, diagnosis
- Medical subject headings
- Periodontitis, Gingivitis, Dental Caries, Disease, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numerical dental impression by intraoral scannerOther
Intervention consists in an 3D intra oral representation of the oral cavity
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Other: Numerical dental impression by intraoral scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (5)
Dento-prosthetic diagram concordance
Recording the presence or absence of tooth The clinical and numerical scored will be compared.
Measured: Day 1
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.
Measured: Day 1
Gingival Index Concordance (Loe and Silness, 1963)
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.
Measured: Day 1
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.
Measured: Day 1
Mucosal lesions detection
Presence or absence of mucosal lesions.
The clinical and numerical lesions will be compared.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start11 May 2022
- Primary completion11 Dec 2027 (estimated)
- Study completion11 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006429
- Sponsor's protocol ID
- PO21146
- Acronym
- Odonto3D
- Status last verified
- Jun 2026
- First submitted
- 17 Aug 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06006429
- Acronym / sponsor ID
- Odonto3D / PO21146
- Conditions
- Periodontitis, Gingivitis, Dental Caries, Diagnosis
- Keywords
- Periodontal diseases, Dental caries, intra-oral camera, diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 Dec 2027 (estimated)
- Study completion
- 11 Dec 2027 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Numerical dental impression by intraoral scanner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- pregnancy or breastfeeding
- orthodontic treatments
- patients under legal protection, trusteeship or guardianship
- unable to understand auto-questionnary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Numerical dental impression by intraoral scannerIntervention consists in an 3D intra oral representation of the oral cavity | Other | Patients |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Numerical dental impression by intraoral scanner in people with Periodontitis and Gingivitis, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien BRAUX (03 26 78 78 24 ext. 0033, jbraux@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession measurement concordance (Ramfjord, 1959) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.