Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction (Perio3D)
Primary Purpose
Periodontitis, Gingivitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intra oral scan
No intervention
Sponsored by
About this trial
This is an interventional prevention trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
Patients
- consulting the Dental Care Service of the university hospital of Reims
- presenting gingivitis or periodontal diseases according to the international classification of periodontal diseases (Chicago, 2017)
- presenting at least 10 pairs of opposing teeth
- able to perform oral hygiene procedures
- speaking French
- who signed the informed consent form
- affiliated to the French Social Security system
Non-inclusion criteria :
Patients presenting :
- a medical history likely to compromise protocol (psychiatric disorders, medical or pharmacological antecedents altering or modifying immune response in last 3 months)
- pregnancy or breastfeeding
- eating disorders
- orthodontic treatments
- patients under legal protection, trusteeship or guardianship
- unable to understand auto-questionary
Exclusion criteria :
Patients presenting :
- presenting exacerbations signs of periodontal diseases
- benefiting a professional plaque removal procedure outside of the experimental procedure
Sites / Locations
- Chu Reims
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional motivation procedure
Conventional motivation procedure supported by 3D representations
Arm Description
Conventional motivation procedures defined as a presentation of the modified Bass technique on a dental teaching macro model plus intra oral instruction provided in patient's mouth with a hand mirror.
Conventional motivation procedures associated with 3D intra oral procedures. A 3D intra-oral modelization will added to the previously described procedure. Then, a periodontist will show the sites contaminated by dental plaque to the patient.
Outcomes
Primary Outcome Measures
Plaque Control Record Evolution
Recording the presence of plaque on individual tooth surfaces (mesial, distal, facial, lingual). The plaque is highlighted by a periodontal probe.
PCR is calculated according the following formula :
PCR = (Number of faces with plaque / Total number of faces) x 100
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05079204
Brief Title
Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction
Acronym
Perio3D
Official Title
Effectiveness of Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Periodontal diseases are highly prevalent inflammatory diseases. These diseases are mostly due to the development and the maturation of bacterial plaque which lead to local inflammation. Individuals can develop severe attachment loss which could lead to dental loss. To prevent them, individual plaque removal procedures self-performed by the patient by tooth brushing or interdental brushes or made by professional care (scaling), are known to improve periodontal health, and thus to prevent periodontal diseases. Moreover, oral hygiene is a major factor to increase increasing the outcomes when treatments are needed. However, patients' compliance in oral health program is one of the major limits to periodontal therapeutics.
In this study, the investigators evaluate the effectiveness of 3D intra-oral camera compared with conventional oral hygiene instructions, to improve oral health motivation.
Detailed Description
The present study explores the effectiveness of intraoral scanners in the field of oral hygiene motivation and instruction to improve the patient's motivation.
Patients presenting periodontitis or gingivitis are recruited and randomized in 2 groups: conventional motivation procedures and conventional motivation procedures supported with 3D representations of their mouth obtained by intraoral scanners. Periodontal diseases (periodontitis and gingivitis) will be diagnosed according to the international classification of periodontal diseases, based on the decision-making algorithms. A periodontal charting, socio-demographic data and clinical data will be collected. Then, oral mucosa dermatological manifestations, treatment needs (ICDAS) and quality of life related to oral health (GOHAI) will be evaluated.
After inclusion, patients will be randomized between conventional motivation procedures and conventional motivation procedures associated with 3D intra oral procedures.
The investigators hypothesized that the 3D intra oral representations could improve oral hygiene in patients compared with those receiving only a classical motivation procedure. The primary objective is to evaluate if patients instructed to oral hygiene procedures using a representation of their mouth obtained by the use of a intraoral scanner present fewer plaque than the ones instructed without it. This could be achieved by the analysis of plaque control record index in both group.
The secondary objectives are :
To compare the evolution of the bleeding on probing clinical index between the two groups.
To compare the evolution of mean periodontal pocket depths, mean recessions and mean clinical attachment level between the two groups.
To compare the quality of life related to oral health between the two groups
To evaluate the time needed to add intraoral scans in the procedure
To evaluate the relevance of the received information.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Gingivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The investigator which perform the periodontal examination will be blinded of the motivation procedure
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional motivation procedure
Arm Type
Active Comparator
Arm Description
Conventional motivation procedures defined as a presentation of the modified Bass technique on a dental teaching macro model plus intra oral instruction provided in patient's mouth with a hand mirror.
Arm Title
Conventional motivation procedure supported by 3D representations
Arm Type
Experimental
Arm Description
Conventional motivation procedures associated with 3D intra oral procedures. A 3D intra-oral modelization will added to the previously described procedure. Then, a periodontist will show the sites contaminated by dental plaque to the patient.
Intervention Type
Other
Intervention Name(s)
Intra oral scan
Other Intervention Name(s)
Conventional motivation procedures supported by 3D representations
Intervention Description
Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study and/or among similar interventions Intervention consists in an 3D intra oral representation of the oral cavity.
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Plaque Control Record Evolution
Description
Recording the presence of plaque on individual tooth surfaces (mesial, distal, facial, lingual). The plaque is highlighted by a periodontal probe.
PCR is calculated according the following formula :
PCR = (Number of faces with plaque / Total number of faces) x 100
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients
consulting the Dental Care Service of the university hospital of Reims
presenting gingivitis or periodontal diseases according to the international classification of periodontal diseases (Chicago, 2017)
presenting at least 10 pairs of opposing teeth
able to perform oral hygiene procedures
speaking French
who signed the informed consent form
affiliated to the French Social Security system
Non-inclusion criteria :
Patients presenting :
a medical history likely to compromise protocol (psychiatric disorders, medical or pharmacological antecedents altering or modifying immune response in last 3 months)
pregnancy or breastfeeding
eating disorders
orthodontic treatments
patients under legal protection, trusteeship or guardianship
unable to understand auto-questionary
Exclusion criteria :
Patients presenting :
presenting exacerbations signs of periodontal diseases
benefiting a professional plaque removal procedure outside of the experimental procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BRAUX
Phone
326787878
Ext
0033
Email
jbraux@chu-reims.fr
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien JOLLY
Phone
326788472
Ext
33
Email
djolly@chu-reims.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction
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