- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06848790
Interdental Hygiene Methods in Young Adults (HIJA)
Effectiveness of Different Methods of Interdental Space Hygiene in Daily Practice Among Young Adults: A Randomized, Single-Blind Controlled Trial
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).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France
- Service de Soins Dentaires Et D'Odontologie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Calibrated interdental brush
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 .
|
participants will use calibrated interdental brushes
|
|
No Intervention: Non-calibrated interdental brush
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 .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interdental bleeding at month 3 (in percentage)
Time Frame: Baseline (T0), 3 months after baseline (T3)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composition of the Interdental microbiome (diversity and total bacteria count)
Time Frame: Baseline (T0)
|
Identification of the composition of the interdental microbiome in healthy young adults using sequencing techniques at T0, in four standardized sites (between teeth 15-16, 25-26, 35-36, and 45-46).
If the specified teeth are missing, exhibit pathologies, or have diastemas preventing interdental cleaning, the sample will be taken from the nearest healthy mesial interdental space.
|
Baseline (T0)
|
|
Periodontal health analysis
Time Frame: Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3)
|
Comparison of periodontal for all participant's teeth (plaque index, gingival index, interdental inflammation, pocket depth and loss of clinical attachment) before (T0), 1 week after baseline (T1), 1 month after baseline (T2) and 3 months after baseline (T3) following the daily use of calibrated versus non-calibrated interdental brushes
|
Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3)
|
|
Periodontal health analysis - salivary pH
Time Frame: Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3)
|
Comparison of periodontal for all participant's teeth (salivary pH) before (T0), 1 week after baseline (T1), 1 month after baseline (T2) and 3 months after baseline (T3) following the daily use of calibrated versus non-calibrated interdental brushes
|
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)
Time Frame: Baseline (T0), 3 months after baseline (T3)
|
Comparison of the composition of the interdental microbiome in healthy young adults using sequencing techniques after 3 months of calibrated versus non calibrated interdental brushed, in four standardized sites (between teeth 15-16, 25-26, 35-36, and 45-46).
If the specified teeth are missing, exhibit pathologies, or have diastemas preventing interdental cleaning, the sample will be taken from the nearest healthy mesial interdental space.
|
Baseline (T0), 3 months after baseline (T3)
|
|
Daily use acceptability of interdental brushes
Time Frame: 1 week after baseline (T1), 1 month after baseline (T2), 3 months after baseline (T3)
|
Evaluation and comparison of the acceptability and ease of integration (by TFA questionnaire) of daily use of calibrated versus non-calibrated interdental brushes, 1 week after baseline (T1), 1 month after baseline (T2) and 3 months after baseline (T3)
|
1 week after baseline (T1), 1 month after baseline (T2), 3 months after baseline (T3)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stéphane VIENNOT, HCL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL24_1272
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontal Diseases
-
Tel Aviv UniversityRecruitingPeriodontal Disease | Periodontal Attachment Loss | Periodontal PocketsIsrael
-
Riga Stradins UniversityUniversity of TurkuRecruitingPeriodontitis | Periodontal Diseases | Periodontal Bone Loss | Periodontal Disease | Periodontal Regeneration | Periodontal Healing | Periodontal Granulation Tissue | Vertical Periodontal Bone DefectsLatvia
-
G. d'Annunzio UniversityRecruitingPeriodontal Diseases | Intrabony Periodontal Defect | Periodontal Attachment Loss | Pocket, PeriodontalAlbania
-
Saglik Bilimleri UniversitesiRecruitingPeriodontitis | Periodontal Diseases | Periodontal Bone Loss | Intrabony Periodontal Defect | Periodontal DefectTurkey (Türkiye)
-
Siddharth ShanbhagUniversidad Complutense de MadridNot yet recruitingPeriodontal Disease | Intrabony Periodontal DefectsNorway, Spain
-
Kafrelsheikh UniversityActive, not recruitingPeriodontal Diseases | Periodontal Attachment LossEgypt
-
Krishnadevaraya College of Dental Sciences & HospitalCompletedPeriodontitis | Periodontal Attachment Loss | Periodontal Inflammation | Pocket, PeriodontalIndia
-
Ohio State UniversityNot yet recruitingPeriodontal Disease | Periodontal SurgeryUnited States
-
University of Roma La SapienzaActive, not recruitingPeriodontal Disease | Periodontal Disease, AVDC Stage 3 | Periodontal Disease Stage 2Italy
-
University of BeykentCompletedPeriodontal Diseases | Periodontal Attachment Loss | Periodontal Inflammation | Periodontal Disease, AVDC Stage 3 | Periodontal Disease, AVDC Stage 4Turkey
Clinical Trials on Calibrated interdental brush
-
Pierre Fabre Dermo CosmetiqueRecruitingPeriodontal DiseaseBelgium
-
National University Health System, SingaporeWithdrawnDental Implants, Single-Tooth
-
University of FreiburgCompleted
-
Özlem SARAÇ ATAGÜNCompletedPeriodontitisTurkey
-
Bulent Ecevit UniversityCompletedOral HygieneTurkey (Türkiye)
-
University of BaghdadCompleted
-
University of SienaCompletedPeri-Implantitis | Peri-implant MucositisItaly
-
Aga Khan UniversityCompleted
-
Medical University InnsbruckCompleted
-
Shanghai Ninth People's Hospital Affiliated to...Recruiting