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

Cerebral Palsy Clinical Trial

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05536648
• Other study ID #: DowUHS clnical trial
• Status: Completed
• Phase: N/A
• Start date: December 18, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: September 2022
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 15, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Zainab Khaliq Ansari	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	DMFT/dmft index	To assess dentition status	At Baseline
Secondary	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