NCT06089564

Brief Summary

Introduction: Oral health is considered as a vital component of overall health and its importance in children may not be disregarded. In children with hearing impairment, communication barriers may hamper their understanding of oral hygiene practices, making them particularly vulnerable to dental problems. Objective: The objective of this study was to compare effectiveness of skit video, pictorial and sign language interventions to improve oral hygiene status of children with hearing impairment. Methods: Sixty children were completed the study and allocated randomly into each group with twenty children as follows: group A: Skit video, group B: Pictorial, and group C: Sign language. Mean gingival and OHI scores were recorded before and after implementation of interventions. Oral hygiene habits, oral hygiene and gingival index scores were recorded by structured questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

April 11, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 19, 2023

Last Update Submit

October 13, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Plaque Index

    Decrease in mean dental plaque scores from baseline to after intervention

    one month

  • Gingival Index

    Decrease in mean gingival scores from baseline to after intervention

    one month

Secondary Outcomes (1)

  • Oral Hygiene Index

    One month

Study Arms (3)

Skit video

ACTIVE COMPARATOR

The video was shown to children lasting for 5 minutes. It was about oral habits, good and bad food. Video was also showed brushing technique.

Behavioral: Skit video, Pictorial, Sign language

Pictorial

ACTIVE COMPARATOR

The pictures related to brushing technique and oral health advices such as good and bad habits was provided in the form of laminated cards. The children has taken those cards along with them.

Behavioral: Skit video, Pictorial, Sign language

Signed Language

NO INTERVENTION

The oral health education related to oral habits, good and bad food was delivered via sign language with the help of children sign language teacher.

Interventions

Three oral health educational intervention groups, group A (skit video), group B (pictorial) and group C (sign language) by using Sequentially Numbered Sealed Opaque Envelopes (SNOSE). Children picked a sealed envelope randomly and assigned to oral health education intervention group A, B and C. Participants in group A were assigned a skit video method of oral hygiene intervention and shown 5 minute video on what to eat and how to brush their teeth. The video included that what is good and bad for teeth, and how to brush which includes method, time and duration of tooth brushing. Participants assigned to group B and C was provided same instructions for tooth brushing and eating habits in the form of pictures and sign language respectively. The children of Group A received instructions in the form of laminated cards and asked to take with them at home. Participants in group C were received instructions in sign language in the presence of teacher.

PictorialSkit video

Eligibility Criteria

Age7 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with hearing impairment and total hearing loss at birth
  • Aged 7 to 20 years for both genders,
  • Minimum of 20 teeth in the oral cavity
  • Children with mild, moderate, and severe gingivitis

You may not qualify if:

  • Children with dental plaque covered more than two-thirds of their tooth surface, had a plaque score of \>1.0
  • Children with fair to poor oral hygiene
  • Children who had previously participated in any activity or programme promoting oral health within the previous six months
  • Children with mild to moderate hearing loss
  • Children taking long-term antibiotics
  • Children who had used mouthwash within the previous three months
  • Children with any known systemic diseases
  • Presence of extensive dental calculus
  • Uncooperative children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ABSA School and college for deaf

Karachi, Sindh, 22770, Pakistan

Location

Ida Rieu College For Blind And Deaf

Karachi, Sindh, 77440, Pakistan

Location

Study Officials

  • Maria Moin, MDS

    Bahria University Dental College

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 18, 2023

Study Start

April 11, 2023

Primary Completion

July 23, 2023

Study Completion

July 25, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations