Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction

NCT ID: NCT05079204

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-04-01

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.

Conditions

Periodontitis; Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conventional motivation procedure

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.

Group Type: ACTIVE_COMPARATOR

No intervention

Intervention Type: OTHER

No intervention

Conventional motivation procedure supported by 3D representations

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.

Group Type: EXPERIMENTAL

Intra oral scan

Intervention Type: OTHER

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.

Interventions

Intra oral scan

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

No intervention

No intervention

Intervention Type: OTHER

Other Intervention Names

Conventional motivation procedures supported by 3D representations

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Reims

Reims, , France

Countries

France

Other Identifiers

PO20159*

Identifier Type: -

Identifier Source: org_study_id