Clinical trial NCT06848790: Interdental Hygiene Methods in Young Adults
Official title: Effectiveness of Different Methods of Interdental Space Hygiene in Daily Practice Among Young Adults: A Randomized, Single-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Microbiota-related Disease
Oral Hygiene
Periodontal Diseases
Keywords: Oral health
Interdental hygiene
Periodontal disease prevention
Interdental microbiota
Preventive care
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Interdental bleeding at month 3 (in percentage)
timeFrame: Baseline (T0), 3 months after baseline (T3)
Secondary outcomes:
measure: Composition of the Interdental microbiome (diversity and total bacteria count)
timeFrame: Baseline (T0)
measure: Periodontal health analysis
timeFrame: Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3)
measure: Periodontal health analysis - salivary pH
timeFrame: Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3)
measure: Interdental microbiota at T3 (diversity and total bacteria count)
timeFrame: Baseline (T0), 3 months after baseline (T3)
measure: Daily use acceptability of interdental brushes
timeFrame: 1 week after baseline (T1), 1 month after baseline (T2), 3 months after baseline (T3)
Other outcomes:
Locations:
Study officials:
affiliation: HCL
name: Stéphane VIENNOT
role: PRINCIPAL_INVESTIGATOR
References: