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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
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
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Palsy focused on measuring plaque status, difficulties assocaited with tooth brushing, triple head tooth brush

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Zainab Khaliq Ansari

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 Single head toothbrush

Group 2 Triple head toothbrush

Arm Description

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

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

Outcomes

Primary Outcome Measures

Plaque Index Score
Plaque score was recorded through Turesky modified Quigley Hein Index to observe improvement in plaque score before and after the intervention.
Difficulties associated with toothbrushing e.g Bleeding during brushing, gag reflex, enable reaching more teeth and time required for brushing.

Secondary Outcome Measures

DMFT/dmft index
To assess dentition status
Oral Hygiene Behavior e.g. brushing frequency, complain of pain and visit to a dentist during last 12 months
Brushing frequency, complain of pain and visit to a dentist during last 12 months.

Full Information

First Posted
September 5, 2022
Last Updated
September 9, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05536648
Brief Title
"Comparing the Plaque Removal Ability of Two Different Toothbrushes Among School Going CP Children
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"
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2021 (Actual)
Primary Completion Date
May 11, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
plaque status, difficulties assocaited with tooth brushing, triple head tooth brush

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single blinded randomized control trial
Masking
Investigator
Masking Description
The dental investigator who perform the oral health assessment for dentition status and plaque status was blinded during the intervention.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Single head toothbrush
Arm Type
Experimental
Arm Description
Cerebral palsy children were given single head tooth brush along with fluoridated toothpaste for brushing.
Arm Title
Group 2 Triple head toothbrush
Arm Type
Experimental
Arm Description
Cerebral palsy children were given triple head tooth brush along with fluoridated toothpaste for brushing.
Intervention Type
Other
Intervention Name(s)
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
Intervention Description
To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.
Primary Outcome Measure Information:
Title
Plaque Index Score
Description
Plaque score was recorded through Turesky modified Quigley Hein Index to observe improvement in plaque score before and after the intervention.
Time Frame
Before and after the intervention of four weeks
Title
Difficulties associated with toothbrushing e.g Bleeding during brushing, gag reflex, enable reaching more teeth and time required for brushing.
Time Frame
At postintervention after four weeks.
Secondary Outcome Measure Information:
Title
DMFT/dmft index
Description
To assess dentition status
Time Frame
At Baseline
Title
Oral Hygiene Behavior e.g. brushing frequency, complain of pain and visit to a dentist during last 12 months
Description
Brushing frequency, complain of pain and visit to a dentist during last 12 months.
Time Frame
At Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Shah, M.Sc,Mphil
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Zainab Khaliq Ansari
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75300
Country
Pakistan

12. IPD Sharing Statement

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