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CompletedNCT05536648Updated Sep 13, 2022

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

An interventional study of 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 in Cerebral Palsy, sponsored by Dow University of Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-13.

Sponsored by Dow University of Health Sciences · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2021, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Cerebral Palsy

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Keywords

  • plaque status
  • difficulties assocaited with tooth brushing
  • triple head tooth brush
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 70 is above the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Dow University of Health Sciences is the lead sponsor of 170 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

    • Children unable to cooperate due to underlying systematic condition because of their motor and mental illness.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
70 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherComparing 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.

06

What researchers measure

Primary outcomes

  1. Plaque Index Score

    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

  2. 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 outcomes

  1. DMFT/dmft index

    To assess dentition status

    Time frame: At Baseline

  2. 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.

    Time frame: At Baseline

07

Study locations

1 site
  • Zainab Khaliq Ansari
    Karachi, Sindh 75300, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05536648
Lead sponsor
Dow University of Health Sciences
Responsible party
Zainab Jahanzeb (Principal Investigator, Dow University of Health Sciences) — Principal investigator
First posted
Sep 13, 2022
Start date
Dec 18, 2021
Primary completion
May 11, 2022
Completion
Jul 15, 2022
Last update
Sep 13, 2022

Study contacts

Nadia Shah, M.Sc,Mphil
study chair · Dow University of Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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