Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools (Odonto3D)
Primary Purpose
Periodontitis, Gingivitis, Dental Caries
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Numerical dental impression by intraoral scanner
Sponsored by
About this trial
This is an interventional prevention trial for Periodontitis focused on measuring Periodontal diseases, Dental caries, intra-oral camera, diagnosis
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
Sites / Locations
- Damien JOLLYRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Dento-prosthetic diagram concordance
Recording the presence or absence of tooth The clinical and numerical scored will be compared.
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.
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.
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.
Mucosal lesions detection
Presence or absence of mucosal lesions.
The clinical and numerical lesions will be compared.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06006429
Brief Title
Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools
Acronym
Odonto3D
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
December 11, 2024 (Anticipated)
Study Completion Date
December 11, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
We 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Gingivitis, Dental Caries, Diagnosis
Keywords
Periodontal diseases, Dental caries, intra-oral camera, diagnosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Numerical dental impression by intraoral scanner
Intervention Description
Intervention consists in an 3D intra oral representation of the oral cavity
Primary Outcome Measure Information:
Title
Recession measurement concordance (Ramfjord, 1959)
Description
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 Outcome Measure Information:
Title
Dento-prosthetic diagram concordance
Description
Recording the presence or absence of tooth The clinical and numerical scored will be compared.
Time Frame
Day 1
Title
Plaque Control Record Concordance (O'Leary et al., 1972)
Description
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
Title
Gingival Index Concordance (Loe and Silness, 1963)
Description
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.
Time Frame
Day 1
Title
Decayed, Missed and Filled Teeth Index (Klein and Palmer, 1940)
Description
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
Title
Mucosal lesions detection
Description
Presence or absence of mucosal lesions.
The clinical and numerical lesions will be compared.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BRAUX
Phone
03 26 78 78 24
Ext
0033
Email
jbraux@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien BRAUX
Phone
03 26 78 78 24
Ext
0033
Email
jbraux@chu-reims.fr
12. IPD Sharing Statement
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Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools
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