NCT06848790

Brief Summary

Oral health is essential for overall well-being and systemic health. A key factor in preserving this health is maintaining the balance of the interdental microbiota, which involves regulating the quantity of pathogenic bacteria in interdental spaces (IS). These IS represent a unique ecological niche where the body has limited specific defense mechanisms, making them vulnerable to infections. In adults, the colonization of interdental spaces by pathogenic bacteria increases the risk of periodontal diseases, which are themselves associated with non-communicable diseases such as cardiovascular diseases, diabetes, and certain types of cancer. Preventing interdental microbiota dysbiosis from a young age is therefore a priority to maintain quality oral health and contribute to good systemic health throughout life. However, conventional brushing techniques cover only accessible tooth surfaces and cannot reach the interdental spaces. Currently, the use of interdental brushes (IDBs) is recognized as the most effective method for interdental hygiene. There are various types of IDBs, differing in several aspects that influence their effectiveness and usability. The main differences relate to their shape, size, and calibration using an interdental probe or not, allowing adaptation to different interdental space sizes. To date, only one study has demonstrated the effectiveness of daily calibrated interdental brush use in reducing dysbiosis and interdental inflammation among young adults. However, no research has yet been conducted to compare the effectiveness of the various types of IDBs available on the market (calibrated versus non-calibrated).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

September 17, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

February 17, 2025

Last Update Submit

April 23, 2026

Conditions

Keywords

Oral healthInterdental hygienePeriodontal disease preventionInterdental microbiotaPreventive care

Outcome Measures

Primary Outcomes (1)

  • Interdental bleeding at month 3 (in percentage)

    Comparison of interdental inflammation (interdental bleeding) following the daily use of calibrated versus non-calibrated interdental brushes at month 3 (T3, expressed as a percentage and assessed at four sites per tooth following probing with a periodontal probe).

    Baseline (T0), 3 months after baseline (T3)

Secondary Outcomes (5)

  • Composition of the Interdental microbiome (diversity and total bacteria count)

    Baseline (T0)

  • Periodontal health analysis

    Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3)

  • Periodontal health analysis - salivary pH

    Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3)

  • Interdental microbiota at T3 (diversity and total bacteria count)

    Baseline (T0), 3 months after baseline (T3)

  • Daily use acceptability of interdental brushes

    1 week after baseline (T1), 1 month after baseline (T2), 3 months after baseline (T3)

Study Arms (2)

Calibrated interdental brush

EXPERIMENTAL

Healthy adult volunteers (not suffering from chronic pathologies) and non-smokers, agreeing to change their interdental hygiene habits for 3 months by daily using a calibrated interdental brushes .

Procedure: Calibrated interdental brush

Non-calibrated interdental brush

NO INTERVENTION

Healthy adult volunteers (not suffering from chronic pathologies) and non-smokers, agreeing to change their interdental hygiene habits for 3 months by daily using a non-calibrated interdental brushes .

Interventions

participants will use calibrated interdental brushes

Calibrated interdental brush

Eligibility Criteria

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

You may qualify if:

  • Person between 18 and 30 years old
  • Person who has given free, informed, express written consent
  • Person affiliated to a French social security system
  • Person living or working in Lyon or the Lyon conurbation served by public transport (TCL)

You may not qualify if:

  • Person with a smoking addiction
  • Person participating in another study related to oral hygiene
  • Patients at high risk of infective endocarditis
  • Person with chronic pathologies
  • Person having taken antibiotic treatment during the month preceding the start of the study
  • Pregnant, parturient or breastfeeding woman
  • Persons deprived of liberty by a judicial or administrative decision
  • People receiving psychiatric care
  • Persons admitted to a health or social establishment for purposes other than research
  • Adults subject to a legal protection measure (guardianship, curatorship)
  • Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
  • Person with fewer than 20 natural teeth
  • Person performing interdental hygiene and/or daily mouthwashes.
  • Person wearing orthodontic appliance
  • Person with periodontal disease (stage ≥ II periodontal lesions according to the Chicago 2017 classification (i.e. PD ≥ 4 mm, and/or CAL ≥ 4 mm) and/or generalized (\>30% of sites )), active caries or during dental care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Soins Dentaires Et D'Odontologie

Lyon, France

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Stéphane VIENNOT

    HCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2025

First Posted

February 27, 2025

Study Start

September 17, 2025

Primary Completion

April 13, 2026

Study Completion

April 13, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations