NCT03030014

Brief Summary

assess the effect of dental educational program on oral hygiene among institutionalized hearing impaired and mute children in Cairo, Egypt.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

January 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

4 months

First QC Date

January 20, 2017

Last Update Submit

February 6, 2017

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    this outcome will be assessed via questionnaire

    6 weeks

Secondary Outcomes (1)

  • oral hygiene index simplified

    6 weeks

Study Arms (2)

educational programm

EXPERIMENTAL

Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing. Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.

Behavioral: educational programm

no educational programm

PLACEBO COMPARATOR

without educational program Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.

Other: no educational program

Interventions

educational programmBEHAVIORAL

Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.

educational programm
no educational programOTHER

without oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.

no educational programm

Eligibility Criteria

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

You may qualify if:

  • Children aged from 6-12 years with mixed dentition.
  • Institutionalized Deaf children in Cairo, Egypt.

You may not qualify if:

  • Children above the age of 12 years and below the age of 6 years
  • Patient un able to give informed consent
  • Patient suffering from any other type of disability such as (mental retardation, physically and mentally handicapped, .etc.)
  • Medically compromised patient
  • Patient who were absent in the day of examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

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
researcher at pedodontic department faculty of oral and dental medicine

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 24, 2017

Study Start

February 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

February 8, 2017

Record last verified: 2017-02