Effectiveness of the Touch-to-Teach Method for Interdental Brushing in Patients With Stage II Grade B Periodontitis.

June 10, 2026 updated by: Gulf Medical University

Effectiveness of the Touch-to-Teach Method for Interdental Brushing in Patients With Stage II Grade B Periodontitis. A Randomized Clinical Trial

In 2018, a collaboration between American Academy of Periodontology (AAP) and European Federation of Periodontology (EFP) yielded a new classification system for periodontal diseases and conditions. The new classification categorized periodontitis into stages from I to IV based on the severity of the disease. Besides the stages, cases were also categorized into A, B and C grades based on the probable progression of the disease. Likewise, cases with interproximal clinical attachment loss of 3-4 mm in the worst affected teeth are considered to be stage II periodontitis.[3] These patients usually do not have tooth loss, can be suffering from localized or generalized type and mostly show horizontal bone loss. There are three types of gingival embrasures. In type I embrasure, the gingival embrasure is filled by the interproximal papilla; whereas in type II and III embrasures interdental papilla loss is seen. Interdental brushing has a vital role in maintaining good oral hygiene and previously published reports have evidenced that successful interdental brushing eliminated interdental plaque below the gingival margin up to 2-2.5 mm. According to the old school of thought, dental floss was advised for type I embrasures, interdental brushes for type II embrasures and unitufted brushes for type III embrasures. Usage of dental floss has been identified to be cumbersome and especially challenging in posterior regions of the oral cavity. Additionally, a recent systematic review in the Cochrane database highlighted the effectiveness of interproximal brushes over dental floss.[9] Recently, the implementation of calibrated interdental brushes use with the availability of interdental brushes with varying sizes, added effectively in creating a healthy interdental papilla in a safe manner. Essentially, a patient-centered and personalized approach named "individually trained oral prophylaxis (iTOP)" has recently been suggested as a solution to remove dental plaque effectively.[10] This concept known as the "Touch-to-Teach" concept provides the patients with an effective method to educate the patients an effective and non-traumatic way of removing interdental plaque.[10] Although, the effectiveness of calibrated interdental brushes showed high efficacy in cases of gingivitis, currently, the effectiveness of these brushes in stage II periodontitis has not been comprehensively studied yet in literature.

Study Overview

Status

Status

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Active, not recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Locations

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients with generalized Stage II periodontitis, diagnosed based on the 2018 classification of periodontal diseases and conditions.[7]
  2. Patients with presence of interproximal clinical attachment loss of ≥ 3-4 mm was used for the diagnosis of periodontitis.
  3. Patients with more than 30% of sites with true periodontal pockets of more than 4 mm with bleeding on probing in the interproximal region.

Exclusion Criteria:

  1. Patients with uncontrolled diabetes mellitus,
  2. Patients smoking ≥ 10 cigarettes per day.
  3. Patients who have undergone scaling and root debridement within the past six months
  4. Patients who were on antimicrobial therapy in the past three months
  5. Patients who were on regular use of anti-plaque mouth rinses in the past three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Interproximal standard hygiene care control group:
The control group was provided with standard oral hygiene instructions (Bass method) and videos regarding maintenance of interdental oral hygiene were provided. Videos regarding oral hygiene maintenance were downloaded from the website of the EFP. Briefly, these animated videos are generated from PerioPixel, which specializes in the generation of animated videos in dentistry, explaining the different oral hygiene techniques and treatments for gingival and periodontal diseases.
Procedure: Interproximal standard hygiene care control group
The control group was provided with standard oral hygiene instructions (Bass method) and videos regarding maintenance of interdental oral hygiene were provided. Videos regarding oral hygiene maintenance were downloaded from the website of the EFP. Briefly, these animated videos are generated from PerioPixel, which specializes in the generation of animated videos in dentistry, explaining the different oral hygiene techniques and treatments for gingival and periodontal diseases.
Experimental: Interproximal "Touch-to-Teach" method hygiene care test group
The test group received interdental hygiene care using the "Touch-to-Teach" method. The Curaprox chairside system includes a range of color-coded interdental brushes selected according to the size of the patient's interdental spaces. The brushes are color-coded as blue, red, pink, yellow, and green, with blue with an interdental accessibility diameter of 0.6m, 0.7 mm, 0.8 mm, 0.9 mm, and 1.1 mm respectively . The kit also contains color-coded colorimetric probes (interdental access probes) that can be used to measure the size of the interproximal space.
Procedure: Interproximal "Touch-to-Teach" method hygiene care test group
The test group received interdental hygiene care using the "Touch-to-Teach" method. The Curaprox chairside system includes a range of color-coded interdental brushes selected according to the size of the patient's interdental spaces. The brushes are color-coded as blue, red, pink, yellow, and green, with blue with an interdental accessibility diameter of 0.6m, 0.7 mm, 0.8 mm, 0.9 mm, and 1.1 mm respectively. The kit also contains color-coded colorimetric probes (interdental access probes) that can be used to measure the size of the interproximal space.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Plaque index
Time Frame: baseline and 3 months
baseline and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bleeding index
Time Frame: baseline and 3 months
baseline and 3 months
Patient Satisfaction VAS scale 0-5
Time Frame: 3 months
VAS scale 0-5
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gulf Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022MDSPerio04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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