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Completed

NCT Number: NCT05536648

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zainab Khaliq Ansari

Karachi, Sindh, 75300, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Plaque Index Score

    Time frame: Before and after the intervention of four weeks

    Plaque score was recorded through Turesky modified Quigley Hein Index to observe improvement in plaque score before and after the intervention.

  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

    Time frame: At Baseline

    To assess dentition status

  2. Oral Hygiene Behavior e.g. brushing frequency, complain of pain and visit to a dentist during last 12 months

    Time frame: At Baseline

    Brushing frequency, complain of pain and visit to a dentist during last 12 months.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study 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"

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2022
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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