Cerebral Palsy, MixedNCT05768568
Comparison of Plaque Removal Efficacy of Powered and Manual Toothbrush Among Children With Cerebral Palsy
A study testing Manual Toothbrush and Powered Toothbrush in people with Cerebral Palsy, Mixed, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
CHildren of Cerebral Palsy(CP) are at high risk of developing dental diseases most commonly periodontitis and caries. Neuromuscular and psychological impact makes it difficult for the CP child to clean dental plaque from the surface of the teeth.inability to perform coordinated movements too makes brushing very… Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Mixed
- What is being tested?
- Manual Toothbrush and Powered Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2023to Dec 2023
- 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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- CP Children aged 12-15 years
- CP children with OHI-S score >1.3 and GI score >1 \& PI score >1
- Subjects with positive consent from schools and parents
- Presence of at least 20 teeth in the mouth
- Independent (mild) CP patients - who are able to perform tooth brushing under supervision assessed by caregiver's account of daily activities.
- Mentally stable
Who cannot join
- Inability to cooperate with the oral examination
- Severe neuromuscular incoordination
- Reluctant or Unable to comprehend consent /or withdrawal of consent
- Participant with calculus deposits at baseline
- Lack of Manual dexterity to perform oral hygiene
- Underlying systemic disease
- Participant requiring emergency dental treatment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Al Umeed Rehabilitation Association (AURA)
Karachi, Sindh, 75330
Colonel Mecol Ali Shah, Graduate, +92 334 1124779, info@alumeed.com
Fasih Ghori, Graduate, +92 334 3736065, libra_thegenius@hotmail.com
About this study
CHildren of Cerebral Palsy(CP) are at high risk of developing dental diseases most commonly periodontitis and caries. Neuromuscular and psychological impact makes it difficult for the CP child to clean dental plaque from the surface of the teeth.inability to perform coordinated movements too makes brushing very difficult and hence it worsens the oral hygiene status.
Hence the objective of the study is to assess plaque removal efficacy of powered toothbrush versus manual toothbrush evaluated by improvement in oral hygiene status of patients with Cerebral Palsy CP children who meet inclusion exclusion criteria will be assessed at different time intervals via Oral hygiene index simplified (OHI-S), plaque index (PI) and gingival index (GI) Scores will be compared and analyzed from baseline, after first phase and after second phase of interventions.
Read the detailed description
Children with cerebral palsy manifests neurologically associated muscular dysfunction. They face difficulty in maintaining posture, gait and locomotion, leading to restricted movements. They are at a higher risk of developing dental diseases most commonly periodontitis and caries. Neuromuscular and psychological impact makes it difficult for the CP child to clean dental plaque from the surface of the teeth. The main cause of dental diseases in CP is ineffective removal of dental plaque. This is due to lack of motor and neuromuscular dysfunction with an inability to understand and comprehend oral hygiene instructions and unable to carryout well-coordinated movements for instance tooth brushing. In a disadvantaged population interventions should be introduced at an early phase of life encouraging it to become part of CP child's daily oral hygiene maintenance regime.
Hence the objective of the study was designed to assess plaque removal efficacy of powered toothbrush versus manual toothbrush evaluated by improvement in oral hygiene status of patients with Cerebral Palsy CP children who will meet the inclusion criteria will be assigned into two groups. Baseline debris, calculus and gingival and plaque status will be recorded using Oral Hygiene Index Simplified (OHI-S) and gingival \& plaque index (PI, GI). The group I will receive a conventional manual toothbrush and group II will be given powered toothbrush. After 4 weeks,will receive powered brush and group II will receive manual brush. After 4 weeks again the subjects will be assessed again for PI, GI, OHI-S. The scores will be compared and analyzed from baseline, after first phase and after second phase of interventions. Repeated measures two way ANOVA with Post Hoc Tukey test. Repeated measures two way ANOVA with Post Hoc Tukey test will be applied on mean GI, PI and OHI-S. Results of phase-I and phase-II will be compared and analyzed
- Conditions
- Cerebral Palsy, Mixed
- Being tested
- Manual Toothbrush and Powered Toothbrush
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Toothbrush and Powered ToothbrushDevice
Manual Toothbrush will be mechanically (hand) driven Powered Toothbrush will be battery operated
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Manual Toothbrush. Receives: Device: Manual Toothbrush and Powered Toothbrush |
| Group II | Active comparator | Powered Toothbrush Receives: Device: Manual Toothbrush and Powered Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Hygiene Status assessed by Oral Hygiene Index Simplified (OHI-S)
According to this Oral Hygiene Index Simplified (OHI-S) The oral hygiene status will be classified as Good (0-1.2), Fair (1.3-3.0), Poor (3.1-6.0)
Measured: 3 months
Oral Hygiene Status assessed by Gingival Index (GI)
Gingival status will be classified as Mild (0.1-1), Moderate (1.1-2) and Sever (2.1-3)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study startApr 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, MixedStudies 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
- Crossover
- Model description
- CP children who will meet the inclusion criteria will be assigned into two groups. Baseline debris, calculus and gingival and plaque status will be recorded using Oral Hygiene Index Simplified (OHI-S) and gingival \& plaque index (PI, GI). The group I will receive a conventional manual toothbrush and group II will be given powered toothbrush. After 4 weeks will receive powered brush and group II will receive manual brush. After 4 weeks again the subjects will be assessed again for PI, GI, OHI-S. The scores will be compared and analyzed from baseline, after first phase and after second phase of interventions
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsin Haider, Dow University of Health Sciences
- Investigators
- Mohsin Haider, BDS, Principal investigator, Dow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768568
- Sponsor's protocol ID
- MH21
- Status last verified
- Mar 2023
- First submitted
- 5 Sep 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plaque Removal Efficacy of Powered and Manual Toothbrush Among Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05768568
- Acronym / sponsor ID
- MH21
- Conditions
- Cerebral Palsy, Mixed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Mar 2023 (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.
CHildren of Cerebral Palsy(CP) are at high risk of developing dental diseases most commonly periodontitis and caries. Neuromuscular and psychological impact makes it difficult for the CP child to clean dental plaque from the surface of the teeth.inability to perform coordinated movements too makes brushing very difficult and hence it worsens the oral hygiene status.
Hence the objective of the study is to assess plaque removal efficacy of powered toothbrush versus manual toothbrush evaluated by improvement in oral hygiene status of patients with Cerebral Palsy CP children who meet inclusion exclusion criteria will be assessed at different time intervals via Oral hygiene index simplified (OHI-S), plaque index (PI) and gingival index (GI) Scores will be compared and analyzed from baseline, after first phase and after second phase of interventions.
Detailed description
Children with cerebral palsy manifests neurologically associated muscular dysfunction. They face difficulty in maintaining posture, gait and locomotion, leading to restricted movements. They are at a higher risk of developing dental diseases most commonly periodontitis and caries. Neuromuscular and psychological impact makes it difficult for the CP child to clean dental plaque from the surface of the teeth. The main cause of dental diseases in CP is ineffective removal of dental plaque. This is due to lack of motor and neuromuscular dysfunction with an inability to understand and comprehend oral hygiene instructions and unable to carryout well-coordinated movements for instance tooth brushing. In a disadvantaged population interventions should be introduced at an early phase of life encouraging it to become part of CP child's daily oral hygiene maintenance regime.
Hence the objective of the study was designed to assess plaque removal efficacy of powered toothbrush versus manual toothbrush evaluated by improvement in oral hygiene status of patients with Cerebral Palsy CP children who will meet the inclusion criteria will be assigned into two groups. Baseline debris, calculus and gingival and plaque status will be recorded using Oral Hygiene Index Simplified (OHI-S) and gingival \& plaque index (PI, GI). The group I will receive a conventional manual toothbrush and group II will be given powered toothbrush. After 4 weeks,will receive powered brush and group II will receive manual brush. After 4 weeks again the subjects will be assessed again for PI, GI, OHI-S. The scores will be compared and analyzed from baseline, after first phase and after second phase of interventions. Repeated measures two way ANOVA with Post Hoc Tukey test. Repeated measures two way ANOVA with Post Hoc Tukey test will be applied on mean GI, PI and OHI-S. Results of phase-I and phase-II will be compared and analyzed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- CP children who will meet the inclusion criteria will be assigned into two groups. Baseline debris, calculus and gingival and plaque status will be recorded using Oral Hygiene Index Simplified (OHI-S) and gingival \& plaque index (PI, GI). The group I will receive a conventional manual toothbrush and group II will be given powered toothbrush. After 4 weeks will receive powered brush and group II will receive manual brush. After 4 weeks again the subjects will be assessed again for PI, GI, OHI-S. The scores will be compared and analyzed from baseline, after first phase and after second phase of interventions
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: Manual Toothbrush and Powered ToothbrushManual Toothbrush. |
| Group II | Active comparator | Device: Manual Toothbrush and Powered ToothbrushPowered Toothbrush |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- CP Children aged 12-15 years
- CP children with OHI-S score >1.3 and GI score >1 \& PI score >1
- Subjects with positive consent from schools and parents
- Presence of at least 20 teeth in the mouth
- Independent (mild) CP patients - who are able to perform tooth brushing under supervision assessed by caregiver's account of daily activities.
Key exclusion criteria (7 listed)
- Inability to cooperate with the oral examination
- Severe neuromuscular incoordination
- Reluctant or Unable to comprehend consent /or withdrawal of consent
- Participant with calculus deposits at baseline
- Lack of Manual dexterity to perform oral hygiene
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 |
|---|---|---|
| Manual Toothbrush and Powered ToothbrushManual Toothbrush will be mechanically (hand) driven Powered Toothbrush will be battery operated | Device | Group I, Group II |
Primary outcome
Oral Hygiene Status assessed by Oral Hygiene Index Simplified (OHI-S)
Time frame: 3 months
According to this Oral Hygiene Index Simplified (OHI-S) The oral hygiene status will be classified as Good (0-1.2), Fair (1.3-3.0), Poor (3.1-6.0)
Oral Hygiene Status assessed by Gingival Index (GI)
Time frame: 3 months
Gingival status will be classified as Mild (0.1-1), Moderate (1.1-2) and Sever (2.1-3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Mohsin Haider, BDS principal investigator
Dow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Toothbrush and Powered Toothbrush in people with Cerebral Palsy, Mixed, 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohsin Haider, BDS (+923452809676, dr.mohsinhaider@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Hygiene Status assessed by Oral Hygiene Index Simplified (OHI-S) (time frame: 3 months). 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 14 Mar 2023.