Cerebral PalsyNCT05536648
"Comparing the Plaque Removal Ability of Two Different Toothbrushes Among School Going CP Children
A study of Cerebral Palsy, run by Dow University of Health Sciences at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Dec 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Parents who give consent to enrol in study and their children (age: 6-18yrs) who cooperate to allow to perform oral assessment.
Who cannot join
- • Children unable to cooperate due to underlying systematic condition because of their motor and mental illness.
Trial locations and contacts
1 site in 1 country.
About this study
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"
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.
- Conditions
- Cerebral Palsy
- Being tested
- 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
- Keywords
- plaque status, difficulties assocaited with tooth brushing, triple head tooth brush
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparing the plaque removal ability of triple head tooth brush versus single head tooth brush among school based cerebral palsy children: A Randomized Control TrialOther
To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Single head toothbrush | Experimental | Cerebral palsy children were given single head tooth brush along with fluoridated toothpaste for brushing. Receives: 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 |
| Group 2 Triple head toothbrush | Experimental | Cerebral palsy children were given triple head tooth brush along with fluoridated toothpaste for brushing. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index Score
Plaque score was recorded through Turesky modified Quigley Hein Index to observe improvement in plaque score before and after the intervention.
Measured: Before and after the intervention of four weeks
Difficulties associated with toothbrushing e.g Bleeding during brushing, gag reflex, enable reaching more teeth and time required for brushing.
Measured: At postintervention after four weeks.
Secondary outcomes (2)
DMFT/dmft index
To assess dentition status
Measured: At Baseline
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.
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start18 Dec 2021
- Primary completion11 May 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blinded randomized control trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Jahanzeb, Dow University of Health Sciences
- Investigators
- Nadia Shah, M.Sc,Mphil, Study chair, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536648
- Sponsor's protocol ID
- DowUHS clnical trial
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT05536648
- Acronym / sponsor ID
- DowUHS clnical trial
- Conditions
- Cerebral Palsy
- Keywords
- plaque status, difficulties assocaited with tooth brushing, triple head tooth brush
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- single blinded randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 Single head toothbrush | Experimental | 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 TrialCerebral palsy children were given single head tooth brush along with fluoridated toothpaste for brushing. |
| Group 2 Triple head toothbrush | Experimental | 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 TrialCerebral palsy children were given triple head tooth brush along with fluoridated toothpaste for brushing. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- • Parents who give consent to enrol in study and their children (age: 6-18yrs) who cooperate to allow to perform oral assessment.
Key exclusion criteria (1 listed)
- • Children unable to cooperate due to underlying systematic condition because of their motor and mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparing the plaque removal ability of triple head tooth brush versus single head tooth brush among school based cerebral palsy children: A Randomized Control TrialTo compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children. | Other | Group 1 Single head toothbrush, Group 2 Triple head toothbrush |
Primary outcome
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.
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.
2 secondary outcomes
DMFT/dmft index
Time frame: At Baseline
Oral Hygiene Behavior e.g. brushing frequency, complain of pain and visit to a dentist during last 12 months
Time frame: At Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Shah, M.Sc,Mphil study chair
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cerebral Palsy, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index Score (time frame: Before and after the intervention of four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.