GingivitisNCT07520994
Efficacy of Devices in Maintaining Oral Health and Managing Periodontal and Interproximal Tissues
A study testing Group 1: use of the rubber interdental brush (picks) at baseline for 3 months and Group 2: use of the traditional bristle interdental brush at baseline for 3 months in people with Gingivitis and Gum Disease, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The aim of the study was to assess the acceptability of the assisted individual and compliance with home use, as well as their clinical impact on the plaque index (PI) and bleeding on probing (BOP), with monthly reassessments allowing for continuous monitoring of all parameters. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Gingivitis, Gum Disease, Oral Health
- What is being tested?
- Group 1: use of the rubber interdental brush (picks) at baseline for 3 months and Group 2: use of the traditional bristle interdental brush at baseline for 3 months
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 30 Apr 2026
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years
- Interdental spaces suitable for the use of interdental brushes
Who cannot join
- Age below 18 or above 50 years
- Presence of periodontitis
- Presence of generalized diastemas
- Presence of removable prostheses or orthodontic appliances
- Presence of tremors or reduced mobility of the upper limbs; adequate oculomotor coordination required
- Type 1 or type 2 diabetes
Show all 15Show fewer
- Immunodeficiency or immunocompromised conditions (e.g., HIV infection)
- Pregnancy or breastfeeding
- Hormonal therapy
- Current pharmacological therapy with drugs known to cause gingival hyperplasia, such as phenytoin, cyclosporine, and calcium channel blockers
- Psychiatric disorders
- Heavy smoking (>10 cigarettes/day)
- Alcohol or drug abuse
- Xerostomia
- Patients with fixed dental implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Various Devices in Maintaining Oral Health and Managing Periodontal Tissues and Interproximal Spaces During Home Oral Hygiene Procedures
The aim of the study was to assess the acceptability of the assisted individual and compliance with home use, as well as their clinical impact on the plaque index (PI) and bleeding on probing (BOP), with monthly reassessments allowing for continuous monitoring of all parameters.
Read the detailed description
The study was conducted as a randomized controlled clinical trial with a crossover design in patients affected by gingivitis. All data were anonymized by assigning a unique identification code to each participant. Subjects were selected according to predefined inclusion and exclusion criteria. Patients aged between 18 and 65 years with interdental spaces suitable for the use of interdental brushes were included.
At baseline (T0), all patients underwent a periodontal clinical examination, including assessment of clinical indices and documentation of initial conditions. A professional oral hygiene session was also performed using ultrasonic instruments and air flow with glycine powder. Patients received instructions for home oral hygiene using a two-tone plaque disclosing agent to highlight areas of greater cleaning difficulty. Initial intraoral conditions were documented photographically. At the end of the session, each patient was assigned to one of two treatment groups. Randomization was performed by coin toss.
All patients were provided with a supply of interdental brushes and received standardized instructions for their use. After collecting clinical indices at baseline (T0), six evaluation time points (T1-T6) were scheduled at 30-day intervals. At each time point, the following clinical parameters were recorded:
- Full Mouth Plaque Score (FMPS)
- Interdental Plaque Index
- Full Mouth Bleeding Score (FMBS)
- Papillary Bleeding Index
Measurements were performed using a standardized millimeter periodontal probe (PCP UNC 15) and a plaque disclosing agent.
At T3 (90 days), a crossover of the interdental devices between the two groups was performed: patients in Group 1 replaced the rubber interdental brush with the bristle device and vice versa. Subsequent clinical assessments were conducted using the same methods until the end of the study (T6). During each follow-up visit, a clinical reassessment was performed, including removal of any residual plaque using air polishing if necessary.
At the end of the study (T6), in addition to recording clinical indices and final photographic documentation, participants completed a 17-item questionnaire designed to assess device acceptability, frequency and method of use, and knowledge of interdental devices. All collected data were recorded digitally and processed for descriptive and comparative statistical analyses between the two treatments.
- Conditions
- Gingivitis, Gum Disease, Oral Health
- Being tested
- Group 1: use of the rubber interdental brush (picks) at baseline for 3 months, Group 2: use of the traditional bristle interdental brush at baseline for 3 months
- Keywords
- Gingivitis, Gum disease, Oral health, Full mouth bleeding score, Full mouth plaque score
- Medical subject headings
- Gingivitis, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: use of the rubber interdental brush (picks) at baseline for 3 monthsDevice
Group 1: use of the rubber interdental brush (picks) at baseline for 3 months, followed by use of the traditional bristle interdental brush for an additional 3 months.
Group 2: use of the traditional bristle interdental brush at baseline for 3 monthsDevice
Group 2: use of the traditional bristle interdental brush at baseline for 3 months, followed by use of the rubber interdental brush for an additional 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1: picks interdental brush (T0), Bristle interdental brush (T3) | Experimental | Group 1: use of the rubber interdental brush (picks) at baseline for 3 months, followed by use of the traditional bristle interdental brush for an additional 3 months. Receives: Device: Group 1: use of the rubber interdental brush (picks) at baseline for 3 months |
| Group 2: Bristle interdental brush (T0), picks interdental brush (T3), | Experimental | Group 2: use of the traditional bristle interdental brush at baseline for 3 months, followed by use of the rubber interdental brush for an additional 3 months Receives: Device: Group 2: use of the traditional bristle interdental brush at baseline for 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full mouth bleeding score
Full Mouth Bleeding Score (FMBS), expressed as the percentage (%) of sites exhibiting bleeding on probing out of the total number of sites examined. The scale ranges from 0% to 100%, where higher percentages indicate more gingival inflammation and a worse outcome.
Measured: From baseline (T0) to the end of the study at 180 days, with follow-up assessments every 30 days (T1-T6).
Full mouth plaque score
Full Mouth Plaque Score (FMPS), expressed as the percentage (%) of sites with visible plaque out of the total number of sites examined. The scale ranges from 0% to 100%, where higher percentages indicate poorer oral hygiene and a worse outcome.
Measured: From baseline (T0) to the end of the study at 180 days, with follow-up assessments every 30 days (T1-T6).
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction, assessed using a structured questionnaire evaluating satisfation with the picks or bristle interdental brush. Mixed scale including categorical preferences (picks vs. rubber) and dichotomous responses (Yes/No) for satisfaction items. Responses are summarized as the percentage (%) of positive ("Yes") answers out of the total number of questions. The scale ranges from 0% to 100%, where higher percentages indicate greater patient satisfaction and a better outcome.
Measured: At 24 weeks after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Sep 2023
- Primary completion1 Nov 2025
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Guerra, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520994
- Sponsor's protocol ID
- 206/2022
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Worthington HV, MacDonald L, Poklepovic Pericic T, Sambunjak D, Johnson TM, Imai P, Clarkson JE. Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries. Cochrane Database Syst Rev. 2019 Apr 10;4(4):CD012018. doi: 10.1002/14651858.CD012018.pub2.
PubMed 30968949
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Various Devices in Maintaining Oral Health and Managing Periodontal Tissues and Interproximal Spaces During Home Oral Hygiene Procedures
- ClinicalTrials.gov ID
- NCT07520994
- Acronym / sponsor ID
- 206/2022
- Conditions
- Gingivitis, Gum Disease, Oral Health
- Keywords
- Gingivitis, Gum disease, Oral health, Full mouth bleeding score, Full mouth plaque score
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 9 Apr 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 the study was to assess the acceptability of the assisted individual and compliance with home use, as well as their clinical impact on the plaque index (PI) and bleeding on probing (BOP), with monthly reassessments allowing for continuous monitoring of all parameters.
Detailed description
The study was conducted as a randomized controlled clinical trial with a crossover design in patients affected by gingivitis. All data were anonymized by assigning a unique identification code to each participant. Subjects were selected according to predefined inclusion and exclusion criteria. Patients aged between 18 and 65 years with interdental spaces suitable for the use of interdental brushes were included.
At baseline (T0), all patients underwent a periodontal clinical examination, including assessment of clinical indices and documentation of initial conditions. A professional oral hygiene session was also performed using ultrasonic instruments and air flow with glycine powder. Patients received instructions for home oral hygiene using a two-tone plaque disclosing agent to highlight areas of greater cleaning difficulty. Initial intraoral conditions were documented photographically. At the end of the session, each patient was assigned to one of two treatment groups. Randomization was performed by coin toss.
All patients were provided with a supply of interdental brushes and received standardized instructions for their use. After collecting clinical indices at baseline (T0), six evaluation time points (T1-T6) were scheduled at 30-day intervals. At each time point, the following clinical parameters were recorded:
- Full Mouth Plaque Score (FMPS)
- Interdental Plaque Index
- Full Mouth Bleeding Score (FMBS)
- Papillary Bleeding Index
Measurements were performed using a standardized millimeter periodontal probe (PCP UNC 15) and a plaque disclosing agent.
At T3 (90 days), a crossover of the interdental devices between the two groups was performed: patients in Group 1 replaced the rubber interdental brush with the bristle device and vice versa. Subsequent clinical assessments were conducted using the same methods until the end of the study (T6). During each follow-up visit, a clinical reassessment was performed, including removal of any residual plaque using air polishing if necessary.
At the end of the study (T6), in addition to recording clinical indices and final photographic documentation, participants completed a 17-item questionnaire designed to assess device acceptability, frequency and method of use, and knowledge of interdental devices. All collected data were recorded digitally and processed for descriptive and comparative statistical analyses between the two treatments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: picks interdental brush (T0), Bristle interdental brush (T3) | Experimental | Device: Group 1: use of the rubber interdental brush (picks) at baseline for 3 monthsGroup 1: use of the rubber interdental brush (picks) at baseline for 3 months, followed by use of the traditional bristle interdental brush for an additional 3 months. |
| Group 2: Bristle interdental brush (T0), picks interdental brush (T3), | Experimental | Device: Group 2: use of the traditional bristle interdental brush at baseline for 3 monthsGroup 2: use of the traditional bristle interdental brush at baseline for 3 months, followed by use of the rubber interdental brush for an additional 3 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 50 years
- Interdental spaces suitable for the use of interdental brushes
Key exclusion criteria (15 listed)
- Age below 18 or above 50 years
- Presence of periodontitis
- Presence of generalized diastemas
- Presence of removable prostheses or orthodontic appliances
- Presence of tremors or reduced mobility of the upper limbs; adequate oculomotor coordination required
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 |
|---|---|---|
| Group 1: use of the rubber interdental brush (picks) at baseline for 3 monthsGroup 1: use of the rubber interdental brush (picks) at baseline for 3 months, followed by use of the traditional bristle interdental brush for an additional 3 months. | Device | Group 1: picks interdental brush (T0), Bristle interdental brush (T3) |
| Group 2: use of the traditional bristle interdental brush at baseline for 3 monthsGroup 2: use of the traditional bristle interdental brush at baseline for 3 months, followed by use of the rubber interdental brush for an additional 3 months | Device | Group 2: Bristle interdental brush (T0), picks interdental brush (T3), |
Primary outcome
Full mouth bleeding score
Time frame: From baseline (T0) to the end of the study at 180 days, with follow-up assessments every 30 days (T1-T6).
Full Mouth Bleeding Score (FMBS), expressed as the percentage (%) of sites exhibiting bleeding on probing out of the total number of sites examined. The scale ranges from 0% to 100%, where higher percentages indicate more gingival inflammation and a worse outcome.
Full mouth plaque score
Time frame: From baseline (T0) to the end of the study at 180 days, with follow-up assessments every 30 days (T1-T6).
Full Mouth Plaque Score (FMPS), expressed as the percentage (%) of sites with visible plaque out of the total number of sites examined. The scale ranges from 0% to 100%, where higher percentages indicate poorer oral hygiene and a worse outcome.
1 secondary outcome
Patient satisfaction
Time frame: At 24 weeks after the start of the study
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 22 Apr 2026.
- Background: PubMed 30968949Worthington HV, MacDonald L, Poklepovic Pericic T, Sambunjak D, Johnson TM, Imai P, Clarkson JE. Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries. Cochrane Database Syst Rev. 2019 Apr 10;4(4):CD012018. doi: 10.1002/14651858.CD012018.pub2.
- 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 Group 1: use of the rubber interdental brush (picks) at baseline for 3 months and Group 2: use of the traditional bristle interdental brush at baseline for 3 months in people with Gingivitis and Gum Disease, run by University of Roma La Sapienza at 1 site in Italy.
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 2 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 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 Italy. 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?
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?
Full mouth bleeding score (time frame: From baseline (T0) to the end of the study at 180 days, with follow-up assessments every 30 days (T1-T6).). 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?
On the ClinicalTrials.gov record for NCT07520994, which also lists 1 linked publication.
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 22 Apr 2026.