NCT06449950

Brief Summary

The aim of this study is to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups. 202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol. Before oral hygiene instructions, baseline oral g of all patients were determined using Simplified Oral Hygiene Index (OHI-S). Within each age group, approximately half of the participants randomly assigned to verbal (n=50 for 6-9 ages, n=51 for 10-12 ages) and video-based OHI (n=51 for 6-9 ages, n=50 for 10-12 ages). Patients were re-called for after 30 days and final OHI-S scores were recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

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

July 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 4, 2024

Last Update Submit

June 4, 2024

Conditions

Keywords

Oral health educationOral hygienePediatric dental patientsToothbrushing

Outcome Measures

Primary Outcomes (1)

  • Simplified Oral Hygiene Index (OHI-S) Scoring

    In the present study, 30 days after verbal and video-based oral hygiene instructions were given to patients, oral hygiene status was similarly determined and recorded using OHI-S index method (OHI-S final scores).

    30 days

Study Arms (2)

Verbal Oral Hygiene Instruction Group

EXPERIMENTAL

Verbal oral hygiene instructions were given to the pediatric patients by the instructor using the Bass brushing technique without any training model or visual aids, only with the verbal instructions.

Behavioral: Behavioral: Verbal Oral Hygiene Instructions

Video-Based Oral Hygiene Instruction Group

EXPERIMENTAL

The video-based oral hygiene instructions to be delivered to the paediatric dental participants were given by watching a pre-prepared video tape on a tooth and jaw model, using the instructions specified in the verbal education.

Behavioral: Behavioral: Video-Based Oral Hygiene Instructions

Interventions

OHI-S index scores of patients who received verbal oral hygiene education were measured at baseline and final (in post-education).

Verbal Oral Hygiene Instruction Group

OHI-S index scores of patients who received video-based oral hygiene education were measured at baseline and final (in post-education).

Video-Based Oral Hygiene Instruction Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6-9 years or 10-12 years
  • Children who were medically free of chronic/systemic conditions
  • Patients without physical or mental disabilities or syndromes
  • Patients without motor dysfunction diseases
  • Patients whose permanent central incisor and permanent first molar teeth had erupted and had not been extracted for any reason

You may not qualify if:

  • Children aged \<6 or \>12 years
  • Children with chronic/systemic conditions
  • Patients with physical or mental disabilities or syndromes
  • Patients with motor dysfunction diseases
  • Patients whose permanent central incisor and permanent first molar teeth had not erupted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (1)

  • Demirel A, Guclu HS, Guclu M, Bagis N. Evaluation of Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomised Clinical Trial. Int J Dent Hyg. 2025 Aug;23(3):575-583. doi: 10.1111/idh.12898. Epub 2025 Jan 29.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor -performing the final examination- carried out the final OHI-S index scoring blindly without knowing which Oral Hygiene Instruction group (verbal and video-based) the participants were in.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: For each age group (6-9 and 10-12) participants were randomly assigned to verbal and video-based oral hygiene instruction groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 10, 2024

Study Start

July 1, 2023

Primary Completion

September 12, 2023

Study Completion

September 12, 2023

Last Updated

June 10, 2024

Record last verified: 2024-06

Locations