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

"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"

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75300
      • Zainab Khaliq Ansari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index Score	Plaque score was recorded through Turesky modified Quigley Hein Index to observe improvement in plaque score before and after the intervention.	Before and after the intervention of four weeks
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

Outcome Measure	Measure Description	Time Frame
DMFT/dmft index	To assess dentition status	At Baseline
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.	At Baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2021
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: plaque status; difficulties assocaited with tooth brushing; triple head tooth brush
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: DowUHS clnical trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No