Clinical trial NCT05536648: "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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: plaque status
difficulties assocaited with tooth brushing
triple head tooth brush
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blinded randomized control trial
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Plaque Index Score
timeFrame: Before and after the intervention of four weeks
measure: Difficulties associated with toothbrushing e.g Bleeding during brushing, gag reflex, enable reaching more teeth and time required for brushing.
timeFrame: At postintervention after four weeks.
Secondary outcomes:
measure: DMFT/dmft index
timeFrame: At Baseline
measure: Oral Hygiene Behavior e.g. brushing frequency, complain of pain and visit to a dentist during last 12 months
timeFrame: At Baseline
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Zainab Khaliq Ansari
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Nadia Shah, M.Sc,Mphil
role: STUDY_CHAIR
References: