NCT06594757

Brief Summary

This randomized controlled trial aimed to determine the effectiveness of a plaque removal by triple-headed manual toothbrush by comparing changes in Rustogi Modifiye Navy Plaque Index. Participants will be divided into two groups and will be made to brush with different designed toothbrushes. The researchers will compare the plaque removal efficiency of the brushes by comparing the changes in the plaque index of the intervention and control groups before and after brushing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

September 9, 2024

Last Update Submit

January 27, 2025

Conditions

Keywords

oral hygieneRustogi Modifiye Navy Plaque IndexModified Bass Techniquetoothbrushdental plaque

Outcome Measures

Primary Outcomes (2)

  • Rustogi Modifiye Navy Plaque Index

    The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.

    1 minute before brushing

  • Rustogi Modifiye Navy Plaque Index

    The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.

    1 minute after brushing

Study Arms (2)

Standart Manual Toothbrush (SMB)

ACTIVE COMPARATOR

Conventional toothbrushing with standart manual toothbrush

Procedure: Toothbrushing with standard manual toothbrush

Triple-Headed Manual Toothbrush (3HB)

EXPERIMENTAL

Toothbrushing with triple-headed manual toothbrush

Procedure: Toothbrushing with triple-headed manual toothbrush

Interventions

Toothbrushing with triple-headed manual toothbrush

Triple-Headed Manual Toothbrush (3HB)

Toothbrushing with tstandard manual toothbrush

Standart Manual Toothbrush (SMB)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age ranging from 18-60 years;
  • a minimum of 12 teeth;
  • participants were wanted to be right-handers when toothbrushing to standardization.

You may not qualify if:

  • Patients with systemic illnesses or conditions,
  • smokers and individuals taking any medication that may affect periodontal health were not included in the study.
  • Individuals who had previously been treated for periodontal disease in the past 6 months were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, 25240_, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Study Officials

  • Didem Özkal Eminoğlu

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

January 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations