"Comparing the Plaque Removal Ability of Two Different Toothbrushes Among School Going CP Children

Sponsor
Dow University of Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT05536648
Collaborator
(none)
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Study Details

Study Description

Brief Summary

It was an intervention utilizing two toothbrushes on school going cerebral palsy children age (6 -18 yrs). The triple head tooth brush and single head brush was provided to parents along with dental health education to their parent on brushing technique and oral care for their child. Parents who give consent for their child were enrolled in the study. The plaque removal ability of toothbrush was assessed by Turesky modified Quigley Hein index. The reading for plaque score was recorded at base line and after the follow up of 4 weeks. Difficulties during brushing was also analyzed.

Condition or Disease Intervention/Treatment Phase
  • Other: Comparing the plaque removal ability of triple head tooth brush versus single head tooth brush among school based cerebral palsy children: A Randomized Control Trial
N/A

Detailed Description

Study Design :Single blinded Randomized Control Trial

Study Setting: The study was conducted in schools that have cerebral palsy children in Karachi.

Study Duration :From June 2021 to June 2022.

Sampling technique: Non probability purposive sampling technique was used for selection of study population.

Sample Size: Total 58 individuals were recruited in the study. After including the 20% drop out rate 35 subjects were enrolled at each study group which make total sample size of 70 Cerebral Palsy participants. Random allocation was made in two groups in order to keep the sizes of intervention groups similar.

Study Instrument:
  • For study intervention two types of tooth brushes were used. The single head and triple head tooth brush.

  • For data collection a structured questionnaire was used that collect information on social demographic characteristics, oral hygiene behavior, dentition status, plaque status and difficulties associated with brushing.

Data Collection Method:
  • The study used a single-blind, parallel, and randomized controlled trial (RCT) design.

  • A total 70 Cerebral palsy children were recruited in the study which was stratified into two groups of 35 children each in intervention and control group.

  • Intervention group was given triple head tooth brush with fluoridated toothpaste whereas control group was given single head tooth brush with fluoridated toothpaste.

  • Dental health education on oral care was given to participant's parent along with brushing technique demonstrated on model as well on their child's teeth.

  • Data was collected through structured questionnaire. Oral health assessment was recorded through DMFT/dmft index. Plaque index was calculated by Turesky modified Quigley Hein index by dyeing the plaque on tooth surface by plaque disclosing tablets. Difficulties during brushing were also evaluated.

  • Statistical analysis involved pair sample t test, repeated measure ANOVA, Chi-square and Fisher's exact test.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
single blinded randomized control trialsingle blinded randomized control trial
Masking:
Single (Investigator)
Masking Description:
The dental investigator who perform the oral health assessment for dentition status and plaque status was blinded during the intervention.
Primary Purpose:
Prevention
Official Title:
"Comparing the Plaque Removal Ability of Triple Head Tooth Brush Versus Single Head Tooth Brush Among School Based Cerebral Palsy Children:A Randomized Control Trial"
Actual Study Start Date :
Dec 18, 2021
Actual Primary Completion Date :
May 11, 2022
Actual Study Completion Date :
Jul 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1 Single head toothbrush

Cerebral palsy children were given single head tooth brush along with fluoridated toothpaste for brushing.

Other: Comparing the plaque removal ability of triple head tooth brush versus single head tooth brush among school based cerebral palsy children: A Randomized Control Trial
To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.

Experimental: Group 2 Triple head toothbrush

Cerebral palsy children were given triple head tooth brush along with fluoridated toothpaste for brushing.

Other: Comparing the plaque removal ability of triple head tooth brush versus single head tooth brush among school based cerebral palsy children: A Randomized Control Trial
To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.

Outcome Measures

Primary Outcome Measures

  1. Plaque Index Score [Before and after the intervention of four weeks]

    Plaque score was recorded through Turesky modified Quigley Hein Index to observe improvement in plaque score before and after the intervention.

  2. Difficulties associated with toothbrushing e.g Bleeding during brushing, gag reflex, enable reaching more teeth and time required for brushing. [At postintervention after four weeks.]

Secondary Outcome Measures

  1. DMFT/dmft index [At Baseline]

    To assess dentition status

  2. Oral Hygiene Behavior e.g. brushing frequency, complain of pain and visit to a dentist during last 12 months [At Baseline]

    Brushing frequency, complain of pain and visit to a dentist during last 12 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • • Parents who give consent to enrol in study and their children (age: 6-18yrs) who cooperate to allow to perform oral assessment.
Exclusion Criteria:
  • • Children unable to cooperate due to underlying systematic condition because of their motor and mental illness.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zainab Khaliq Ansari Karachi Sindh Pakistan 75300

Sponsors and Collaborators

  • Dow University of Health Sciences

Investigators

  • Study Chair: Nadia Shah, M.Sc,Mphil, Dow University of Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zainab Jahanzeb, Principal Investigator, Dow University of Health Sciences
ClinicalTrials.gov Identifier:
NCT05536648
Other Study ID Numbers:
  • DowUHS clnical trial
First Posted:
Sep 13, 2022
Last Update Posted:
Sep 13, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zainab Jahanzeb, Principal Investigator, Dow University of Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2022