NCT05079204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

October 5, 2021

Last Update Submit

April 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 14

Study Arms (2)

Conventional motivation procedure

ACTIVE COMPARATOR

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.

Other: No intervention

Conventional motivation procedure supported by 3D representations

EXPERIMENTAL

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.

Other: Intra oral scan

Interventions

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.

Also known as: Conventional motivation procedures supported by 3D representations
Conventional motivation procedure supported by 3D representations

No intervention

Conventional motivation procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients presenting :
  • presenting exacerbations signs of periodontal diseases
  • benefiting a professional plaque removal procedure outside of the experimental procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

PeriodontitisGingivitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator which perform the periodontal examination will be blinded of the motivation procedure
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 15, 2021

Study Start

September 30, 2022

Primary Completion

September 30, 2022

Study Completion

April 1, 2025

Last Updated

April 3, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations