NCT07650747

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 7, 2026

Last Update Submit

June 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Plaque index

    baseline and 3 months

Secondary Outcomes (2)

  • Bleeding index

    baseline and 3 months

  • Patient Satisfaction VAS scale 0-5

    3 months

Study Arms (2)

Interproximal standard hygiene care control group:

ACTIVE COMPARATOR

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

Interproximal "Touch-to-Teach" method hygiene care test group

EXPERIMENTAL

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

Interventions

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.

Interproximal standard hygiene care control 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.

Interproximal "Touch-to-Teach" method hygiene care test group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulf Medical University

Ajman, United Arab Emirates

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2026

First Posted

June 16, 2026

Study Start

January 1, 2025

Primary Completion

February 1, 2026

Study Completion

June 10, 2026

Last Updated

July 2, 2026

Record last verified: 2026-06

Locations