Periodontal DiseaseNCT07575997
Comparison Between Different Interdental Brushes in Adults With Periodontal Disease.
A study testing Test interdental brush and Comparative interdental brush in people with Periodontal Disease, run by Pierre Fabre Dermo Cosmetique at 1 site in Belgium.
Trial summary
The aim of this exploratory study is to evaluate the efficacy of the tested interdental brush versus comparative interdental brushes in adults with periodontal disease, over a 4-week period. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Test interdental brush and Comparative interdental brush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Apr 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject aged between 18 and 80 years included
- Subject having signed his/her written informed consent for his/her participation in the study
- Subject diagnosed with active generalized periodontal disease (excluding gingivitis)
- Subject having at least 20 natural teeth (10 teeth on each side (right and left))
- Non-inclusion criteria:
- Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing and to report required information in a questionnaire
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- For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study
- Subject having any other oral condition than periodontal disease (ex: dermatologic ulcers), or any orthodontic conditions liable to interfere with the study assessment or considered by the investigator hazardous for the subject or incompatible with study requirements
- Systemic treatment or topical treatment/product currently taken/applied in the mouth liable to interfere with study assessments according to the investigator or planned to be taken/applied during the study
- Subject has received periodontal therapy (scaling, root planing, surgery, etc.) within 2 months before the inclusion
- Subject who has undergone oral or gum surgery within 2 months before the inclusion, or planned to be performed during the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Selena TOMA, Pr., + 32 2 764 57 14, selena.toma@uclouvain.be
About this study
Official title: A Clinical Study Evaluating the Efficacy of an Interdental Brush Versus Comparators in Adults With Periodontal Disease.
The aim of this exploratory study is to evaluate the efficacy of the tested interdental brush versus comparative interdental brushes in adults with periodontal disease, over a 4-week period.
Read the detailed description
This study will take place at a single center as an intra-individual, split mouth, randomized, comparative study to evaluate the efficacy of the tested interdental brushes versus the comparative interdental brushes in adults with periodontal disease, over a 4-week period.
3 visits are planned:
- Visit 0: Pre-inclusion (Day -21 to Day 1): Information of the study given to subject, checking eligibility criteria orally
- Visit 1: Inclusion visit (Day 1): Randomization and Start of interdental brushes use (tested and comparative on each split-mouth)
- Visit 2: End of study (Day 29 +/-7 days , i.e. 1 month after inclusion)
- Conditions
- Periodontal Disease
- Being tested
- Test interdental brush, Comparative interdental brush
- Keywords
- Periodontal Disease, Interdental Brushes
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test interdental brushOther
Interdental brush to be used twice a day during the whole study.
Comparative interdental brushOther
Interdental brush to be used twice a day during the whole study.
| Study group | Role | What they receive |
|---|---|---|
| Test interdental brush | Other | Each subject uses the test interdental brush on one side of the mouth for 4 weeks. Receives: Other: Test interdental brush |
| Comparative interdental brush | Other | Each subject uses the comparative interdental brush on the contralateral side of the mouth for 4 weeks. Receives: Other: Comparative interdental brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on dental plaque
Dental plaque (%) will be assessed according to the O'Leary method on each side of the mouth.
Measured: Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Effect on gingival bleeding
Gingival bleeding (%) will be assessed on each side of the mouth.
Measured: Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Effect on pocket depth
Pocket depth (mm) will be assessed on each side of the mouth.
Measured: Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Interdental hygiene assessment by subject
Interdental hygiene on each side of the mouth at Visit 2 compared to Visit 1 will be assessed by the subject using a 4-point scale (0: no change, -1: slightly improvement, 2: improvement, 3: significant improvement)
Measured: Visit 2 (Day 29).
Adverse events recording
Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation
Measured: From Visit 1 (Day 1) to Visit 2 (Day 29)
Acceptability Questionnaire assessment
Acceptability questionnaire regarding the use of the interdental brushes will be completed by the subject.
Measured: Visit 2 (Day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start10 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intra-individual split-mouth randomized comparative study in adults with periodontal disease. Subjects enrolled in the study will use the test interdental brush on one side of the mouth and comparative interdental brush on contralateral side of the mouth for 4 weeks.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Selena TOMA, Pr., Principal investigator, UC Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575997
- Sponsor's protocol ID
- PR52952025001
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Efficacy of an Interdental Brush Versus Comparators in Adults With Periodontal Disease.
- ClinicalTrials.gov ID
- NCT07575997
- Acronym / sponsor ID
- PR52952025001
- Conditions
- Periodontal Disease
- Keywords
- Periodontal Disease, Interdental Brushes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this exploratory study is to evaluate the efficacy of the tested interdental brush versus comparative interdental brushes in adults with periodontal disease, over a 4-week period.
Detailed description
This study will take place at a single center as an intra-individual, split mouth, randomized, comparative study to evaluate the efficacy of the tested interdental brushes versus the comparative interdental brushes in adults with periodontal disease, over a 4-week period.
3 visits are planned:
- Visit 0: Pre-inclusion (Day -21 to Day 1): Information of the study given to subject, checking eligibility criteria orally
- Visit 1: Inclusion visit (Day 1): Randomization and Start of interdental brushes use (tested and comparative on each split-mouth)
- Visit 2: End of study (Day 29 +/-7 days , i.e. 1 month after inclusion)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intra-individual split-mouth randomized comparative study in adults with periodontal disease. Subjects enrolled in the study will use the test interdental brush on one side of the mouth and comparative interdental brush on contralateral side of the mouth for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Test interdental brush | Other | Other: Test interdental brushEach subject uses the test interdental brush on one side of the mouth for 4 weeks. |
| Comparative interdental brush | Other | Other: Comparative interdental brushEach subject uses the comparative interdental brush on the contralateral side of the mouth for 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject aged between 18 and 80 years included
- Subject having signed his/her written informed consent for his/her participation in the study
- Subject diagnosed with active generalized periodontal disease (excluding gingivitis)
- Subject having at least 20 natural teeth (10 teeth on each side (right and left))
- Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing and to report required information in a questionnaire
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test interdental brushInterdental brush to be used twice a day during the whole study. | Other | Test interdental brush |
| Comparative interdental brushInterdental brush to be used twice a day during the whole study. | Other | Comparative interdental brush |
Primary outcome
Effect on dental plaque
Time frame: Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Dental plaque (%) will be assessed according to the O'Leary method on each side of the mouth.
Effect on gingival bleeding
Time frame: Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Gingival bleeding (%) will be assessed on each side of the mouth.
Effect on pocket depth
Time frame: Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Pocket depth (mm) will be assessed on each side of the mouth.
Interdental hygiene assessment by subject
Time frame: Visit 2 (Day 29).
Interdental hygiene on each side of the mouth at Visit 2 compared to Visit 1 will be assessed by the subject using a 4-point scale (0: no change, -1: slightly improvement, 2: improvement, 3: significant improvement)
Adverse events recording
Time frame: From Visit 1 (Day 1) to Visit 2 (Day 29)
Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation
Acceptability Questionnaire assessment
Time frame: Visit 2 (Day 29)
Acceptability questionnaire regarding the use of the interdental brushes will be completed by the subject.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Selena TOMA, Pr. principal investigator
UC Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test interdental brush and Comparative interdental brush in people with Periodontal Disease, run by Pierre Fabre Dermo Cosmetique at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adeline BACQUEY (0534506533, adeline.bacquey@pierre-fabre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on dental plaque (time frame: Change from Visit 1 (Day 1) to Visit 2 (Day 29).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.