Oral HygieneNCT07150910
Clinical Efficacy and Patient Acceptance of Interdental Brushes and Rubber Bristles in Patients With Gingivitis
A study testing Interdental brush and Rubber bristles interdental cleaner in people with Oral Hygiene, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this clinical study is to compare the effects of IDBs and RBICs on the removal of microbial dental plaque and gingival bleeding in patients with gingivitis. Secondarily, the study aims to assess participants' satisfaction and attitudes toward using these tools. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Interdental brush and Rubber bristles interdental cleaner
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2021to 26 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- probing sulcus depth ≤ 3 mm and full-mouth bleeding on probing (BOP) score ≥ 20%
- presence of at least 20 natural teeth (excluding third molars), with a minimum of five teeth per quadrant
- at least four evaluable interproximal sites without crowns or restorations in each quadrant of the maxilla and mandible
- compatibility of both interdental cleaning devices with a minimum of four interproximal spaces per quadrant
- no prior experience with interdental cleaning tools
- willing to participate
- capable of understanding and complying with the study procedures and instructions.
Who cannot join
- smoking
- presence of severe gingivitis or clinical attachment loss
- systemic diseases
- use of antibiotics within the past three months
- use of anticoagulant medications or mouthwashes
- pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Clinical Efficacy and Patient Acceptance of Interdental Brushes and Rubber Bristles Interdental Cleaners in Patients With Gingivitis: A Randomized Controlled Trial
The primary aim of this clinical study is to compare the effects of IDBs and RBICs on the removal of microbial dental plaque and gingival bleeding in patients with gingivitis. Secondarily, the study aims to assess participants' satisfaction and attitudes toward using these tools.
Read the detailed description
This study involved 40 systemically healthy, right-handed, non-smoking patients aged 18-35 with gingivitis and no prior experience with interdental cleaning tools. Inclusion criteria required a probing depth ≤3mm, a full-mouth bleeding on probing score ≥20%, at least 20 natural teeth, and a minimum of four evaluable interproximal sites per quadrant compatible with both test devices. Key exclusion criteria were severe gingivitis, attachment loss, systemic diseases, recent antibiotic use, and pregnancy.
Participants received standardized toothpaste, a toothbrush, and training in the modified Stillman brushing technique. Following a 2-week training phase on product use and a professional prophylaxis, they refrained from interdental cleaning for 3 days to allow plaque accumulation for baseline assessments (T-QHPI for plaque, PBI for gingival bleeding).
The study employed a split-mouth design. After baseline, one side of the mouth was assigned an interdental brush (IDB - TePe® Original, sizes 0.4-1.5mm) for daily use, and the contralateral side was assigned a rubber bristle interdental cleaner (RBIC - TePe EasyPick™, XS/S or M/L size). Participants were instructed on proper insertion and technique for each device.
After two weeks of use, clinical indices were re-recorded by a blinded examiner. Additionally, participants completed a questionnaire assessing their satisfaction with various aspects of the products (cleaning capacity, accessibility, ease of use, overall satisfaction, willingness to reuse, and pain experienced during use).
- Conditions
- Oral Hygiene
- Being tested
- Interdental brush, Rubber bristles interdental cleaner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdental brushBehavioural
In accordance with the manufacturer's recommendations, the IDBs were stated to be suitable for multiple uses. Participants were advised to replace the IDB once the bristles lost their shape or if the metal wire became damaged.
Rubber bristles interdental cleanerBehavioural
Two sizes were selected for the study: XS/S - Orange, designed for narrow and very narrow interdental spaces, and M/L - Turquoise, suitable for medium to large spaces. Since the tested RBICs were designed by the manufacturer for single use, participants were instructed to use a new RBIC at each application.
| Study group | Role | What they receive |
|---|---|---|
| IDB | Active comparator | The interdental brush(IDB) used in the study (TePe® Interdental Brushes Original) is available in nine different sizes, color-coded according to brush diameter, ranging from 0.4 mm to 1.5 mm Receives: Behavioral: Interdental brush |
| RBIC | Active comparator | The rubber bristles interdental cleaner features soft, flexible, and tapered synthetic rubber bristles. Receives: Behavioral: Rubber bristles interdental cleaner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Levels
Plaque levels were assessed using the Turesky modification of the Quigley and Hein Plaque Index (T-QHPI). In each participant, dental plaque was disclosed using Mira-2-Ton® (Duisburg, Germany) and then rinsed with water (10 mL for 10 seconds). The stained plaque was scored on a scale from 0 to 5 as follows: 0 = no plaque; 1 = separate flecks of plaque at the cervical margin; 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin; 3 = plaque covering not more than one-third of the tooth surface; 4 = plaque covering more than one-third but not more than two-thirds of the tooth surface; 5 = plaque covering more than two-thirds of the tooth surface.
Measured: 2 weeks
Gingival condition
Gingival condition was evaluated using the Papillary Bleeding Index (PBI) introduced by Saxer and Mühlemann. Measurements were performed by a blinded, calibrated examiner on four sites per tooth (mesiobuccal, distobuccal, mesiolingual, and distolingual). A manual UNC-15 mm periodontal probe (Hu-Friedy, Chicago, IL, USA) was carefully inserted into the gingival sulcus at the base of the papilla on the mesial side and moved coronally toward the tip of the papilla. The same procedure was repeated on the distal aspect. Bleeding severity was scored on a scale from 0 to 4: 0 = no bleeding; 1 = a single discreet bleeding point visible after 20 seconds; 2 = a fine line of blood or multiple bleeding points in the papilla; 3 = blood filling the entire interdental space; 4 = profuse bleeding that overflows from the interdental area
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start6 Sep 2021
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut BALLI, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150910
- Sponsor's protocol ID
- 2021/15
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Efficacy and Patient Acceptance of Interdental Brushes and Rubber Bristles Interdental Cleaners in Patients With Gingivitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07150910
- Acronym / sponsor ID
- 2021/15
- Conditions
- Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 2 Sep 2025 (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 primary aim of this clinical study is to compare the effects of IDBs and RBICs on the removal of microbial dental plaque and gingival bleeding in patients with gingivitis. Secondarily, the study aims to assess participants' satisfaction and attitudes toward using these tools.
Detailed description
This study involved 40 systemically healthy, right-handed, non-smoking patients aged 18-35 with gingivitis and no prior experience with interdental cleaning tools. Inclusion criteria required a probing depth ≤3mm, a full-mouth bleeding on probing score ≥20%, at least 20 natural teeth, and a minimum of four evaluable interproximal sites per quadrant compatible with both test devices. Key exclusion criteria were severe gingivitis, attachment loss, systemic diseases, recent antibiotic use, and pregnancy.
Participants received standardized toothpaste, a toothbrush, and training in the modified Stillman brushing technique. Following a 2-week training phase on product use and a professional prophylaxis, they refrained from interdental cleaning for 3 days to allow plaque accumulation for baseline assessments (T-QHPI for plaque, PBI for gingival bleeding).
The study employed a split-mouth design. After baseline, one side of the mouth was assigned an interdental brush (IDB - TePe® Original, sizes 0.4-1.5mm) for daily use, and the contralateral side was assigned a rubber bristle interdental cleaner (RBIC - TePe EasyPick™, XS/S or M/L size). Participants were instructed on proper insertion and technique for each device.
After two weeks of use, clinical indices were re-recorded by a blinded examiner. Additionally, participants completed a questionnaire assessing their satisfaction with various aspects of the products (cleaning capacity, accessibility, ease of use, overall satisfaction, willingness to reuse, and pain experienced during use).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDB | Active comparator | Behavioral: Interdental brushThe interdental brush(IDB) used in the study (TePe® Interdental Brushes Original) is available in nine different sizes, color-coded according to brush diameter, ranging from 0.4 mm to 1.5 mm |
| RBIC | Active comparator | Behavioral: Rubber bristles interdental cleanerThe rubber bristles interdental cleaner features soft, flexible, and tapered synthetic rubber bristles. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- probing sulcus depth ≤ 3 mm and full-mouth bleeding on probing (BOP) score ≥ 20%
- presence of at least 20 natural teeth (excluding third molars), with a minimum of five teeth per quadrant
- at least four evaluable interproximal sites without crowns or restorations in each quadrant of the maxilla and mandible
- compatibility of both interdental cleaning devices with a minimum of four interproximal spaces per quadrant
- no prior experience with interdental cleaning tools
Key exclusion criteria (6 listed)
- smoking
- presence of severe gingivitis or clinical attachment loss
- systemic diseases
- use of antibiotics within the past three months
- use of anticoagulant medications or mouthwashes
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 |
|---|---|---|
| Interdental brushIn accordance with the manufacturer's recommendations, the IDBs were stated to be suitable for multiple uses. Participants were advised to replace the IDB once the bristles lost their shape or if the metal wire became damaged. | Behavioural | IDB |
| Rubber bristles interdental cleanerTwo sizes were selected for the study: XS/S - Orange, designed for narrow and very narrow interdental spaces, and M/L - Turquoise, suitable for medium to large spaces. Since the tested RBICs were designed by the manufacturer for single use, participants were instructed to use a new RBIC at each application. | Behavioural | RBIC |
Primary outcome
Plaque Levels
Time frame: 2 weeks
Plaque levels were assessed using the Turesky modification of the Quigley and Hein Plaque Index (T-QHPI). In each participant, dental plaque was disclosed using Mira-2-Ton® (Duisburg, Germany) and then rinsed with water (10 mL for 10 seconds). The stained plaque was scored on a scale from 0 to 5 as follows: 0 = no plaque; 1 = separate flecks of plaque at the cervical margin; 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin; 3 = plaque covering not more than one-third of the tooth surface; 4 = plaque covering more than one-third but not more than two-thirds of the tooth surface; 5 = plaque covering more than two-thirds of the tooth surface.
Gingival condition
Time frame: 2 weeks
Gingival condition was evaluated using the Papillary Bleeding Index (PBI) introduced by Saxer and Mühlemann. Measurements were performed by a blinded, calibrated examiner on four sites per tooth (mesiobuccal, distobuccal, mesiolingual, and distolingual). A manual UNC-15 mm periodontal probe (Hu-Friedy, Chicago, IL, USA) was carefully inserted into the gingival sulcus at the base of the papilla on the mesial side and moved coronally toward the tip of the papilla. The same procedure was repeated on the distal aspect. Bleeding severity was scored on a scale from 0 to 4: 0 = no bleeding; 1 = a single discreet bleeding point visible after 20 seconds; 2 = a fine line of blood or multiple bleeding points in the papilla; 3 = blood filling the entire interdental space; 4 = profuse bleeding that overflows from the interdental area
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdental brush and Rubber bristles interdental cleaner in people with Oral Hygiene, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 8 Sep 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Levels (time frame: 2 weeks). The study lists 2 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 Sep 2025.