NCT07585448

Brief Summary

The goal of this match-pair randomized study is to compare the effectiveness of the standard Audio-Tactile Performance (ATP) technique with a song-based adaptation (ATP/S) in teaching oral hygiene in visually impaired individuals aged 6 to 20 years in Kathmandu, Nepal.

  1. 1.Can the ATP/S approach achieve a greater improvement in plaque control, as measured by the Patient Hygiene Performance (PHP) index, compared to standard ATP instruction over a two-week period?
  2. 2.Does the rhythmic structure of a song lead to a more continuous improvement in toothbrushing task performance and theoretical oral health knowledge?

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 Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

June 9, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
Last Updated

May 13, 2026

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

May 7, 2026

Last Update Submit

May 7, 2026

Conditions

Keywords

audio-tactile performance techniquesing along songtooth brushing task analysis

Outcome Measures

Primary Outcomes (1)

  • tooth brushing task analysis

    The oral cavity is divided into 16 surface areas. Scoring Criteria: For each area, participants are scored on four specific criteria: 1. Maintaining a 45-degree angle of the bristles. 2. Using an appropriate back-and-forth vibrating motion. 3. Ensuring adequate surface coverage. 4. Brushing for at least 5 seconds per surface. Calculation: Each correctly executed criterion earns 1 point, and the total skill level is determined by the percentage of points achieved out of the total possible points.

    from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)

Secondary Outcomes (1)

  • Patient hygiene performance (PHP score)

    from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)

Other Outcomes (1)

  • Oral Health Knowledge Questionnaire

    from baseline, intervention, reinforcement (1 week) and final data collection (end of 2 week)

Study Arms (2)

ATP with audio information file

ACTIVE COMPARATOR

Participants in this arm receive Oral Hygiene Instruction (OHI) using the standard Audio-Tactile Performance (ATP) technique. This involves hands-on training with a tooth model (dentoform) paired with a pre-recorded audio information file that provides verbal instructions on brushing techniques.

Procedure: ATP

ATP with informational song

EXPERIMENTAL

Group B (Intervention Group): Participants in this arm receive OHI using the ATP technique enhanced with a sing-along song. This method utilizes the same hands-on training with a tooth model but replaces the standard audio file with a culturally adapted song containing the brushing instructions, leveraging rhythmic entrainment to aid memory and coordination.

Behavioral: ATP with song

Interventions

ATPPROCEDURE

ATP with standard audio file

ATP with audio information file
ATP with songBEHAVIORAL

ATP with informational song used to provide guidance to the participants

ATP with informational song

Eligibility Criteria

Age6 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Bilateral visually impaired in age 6-20yrs. (as verified in school medical record)

You may not qualify if:

  • Visual impairment associated with any disabilities that affected arm motor skill/loss of upper dexterous extremity/abnormal mental development/deaf.
  • Using any chemical plaque control agent.
  • Individuals with calculus on examining teeth
  • On medications that could affect the gingival status.
  • Inability to brush due to pain from severe caries/oro-mucosal conditions.
  • Have less than 4 teeth in each quadrant.
  • Presented with orthodontic or prosthodontic appliance.
  • Subject with good oral hygiene ; plaque score = 0
  • Un co-operative children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laboratory boarding Secondary school

Ki̇̄rtipur, Kathmandu, 44600, Nepal

Location

Namuna Macchindra secondary school

Lalitpur, Lagankhel, 44600, Nepal

Location

MeSH Terms

Interventions

Adenosine Triphosphate

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • woranun Prapansilp, Masters pediatric dentistry

    Mahidol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Dental Examiners: Two dental examiners were blinded to the group assignments (Control vs. Intervention). This was critical to ensure that the measurement of PHP scores, the evaluation of toothbrushing task analysis steps and the oral health knowledge were not influenced by whether the student used the standard audio or the song. two schools were randomly allocated in un-named envelop and picked on the day of intervention
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 13, 2026

Study Start

June 9, 2025

Primary Completion

August 22, 2025

Study Completion

October 30, 2025

Last Updated

May 13, 2026

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations