NCT05099146

Brief Summary

Objective: To compare the impact of pictorial and video demonstration oral health educational interventions on oral hygiene status of children aged 12-16 years with hearing impairment. Methods: This randomized controlled trial spanned over the period of three months was conducted in purposively selected three schools of deaf children of Karachi. Baseline dental examination was performed to assess the dental plaque and gingival status of study participants. Dental plaque and gingival status of the participants was assessed by employing the World Health Organization recommended Plaque Index and Gingival Index. The 60 children were than randomly allocated into three interventional groups, pictorial, video and control, 20 in each group. The children were examined again after one month of oral health education provision by single examiner. Tooth brushes were provided to students at the time of baseline examination to use for one month. Collected data was subjected to statistical analysis and described in terms of Mean and Standard Deviation, mixed model ANNOVA was applied to see the difference between the mean plaque and gingival scores of three groups after one month. The p-value of \<0.05 was considered as statistically significant at the 95% confidence interval.

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 Oct 2019

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

October 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

September 13, 2021

Last Update Submit

November 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • change of dental plaque status

    Assessed by plaque index, Change of plaque score From high to low levels after1 month

    one month

Secondary Outcomes (1)

  • Change in oral hygiene status

    one month

Study Arms (3)

pictorial

EXPERIMENTAL

brushing technique taught by using pictures

Behavioral: pictures

video

EXPERIMENTAL

brushing technique taught by showing video

Behavioral: video

control

EXPERIMENTAL

only oral hygiene instructions provided

Behavioral: control

Interventions

picturesBEHAVIORAL

pictures with brushing technique demonstrated technique for proper brushing

pictorial
videoBEHAVIORAL

video of brushing technique demonstrated technique for proper brushing

video
controlBEHAVIORAL

oral hygiene instructions provided

control

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with hearing impairment
  • Children with age of 12-16 years
  • Children with no systemic disease
  • Children with Plaque adhering to the free gingival margin, more than one third and more than two thirds of tooth surface
  • Children with mild, moderate and severe gingivitis
  • Agreement on written accent
  • Agreement to comply with study visits and procedure

You may not qualify if:

  • Conditions requiring antibiotic pre-medication prior to dental examination
  • Children with extensive dental calculus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ida Rieu College For Blind And Deaf

Karachi, Sindh, 77440, Pakistan

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Motion PicturesVideotape Recording

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Audiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTape RecordingTelevision

Study Officials

  • MARIA MOIN, MDS

    DOW UNIVERSITY OF HEALTH SCINCES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2021

First Posted

October 29, 2021

Study Start

October 5, 2019

Primary Completion

December 5, 2019

Study Completion

January 2, 2020

Last Updated

November 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations