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

NCT ID: NCT05536648

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-18
• Study Completion Date: 2022-07-15

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group 1 Single head toothbrush

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

Group Type: EXPERIMENTAL

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 Type: OTHER

To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.

Group 2 Triple head toothbrush

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

Group Type: EXPERIMENTAL

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 Type: OTHER

To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zainab Jahanzeb

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadia Shah, M.Sc,Mphil

Role: STUDY_CHAIR

Dow University of Health Sciences

Locations

Zainab Khaliq Ansari

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

DowUHS clnical trial

Identifier Type: -

Identifier Source: org_study_id