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Comparison of Plaque Removal Efficacy of Powered and Manual Toothbrush Among Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy, Mixed

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Manual Toothbrush and Powered Toothbrush
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Palsy, Mixed

Eligibility Criteria

12 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Al Umeed Rehabilitation Association (AURA)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Arm Description

Manual Toothbrush.

Powered Toothbrush

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Full Information

First Posted
September 5, 2021
Last Updated
March 3, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05768568
Brief Title
Comparison of Plaque Removal Efficacy of Powered and Manual Toothbrush Among Children With Cerebral Palsy
Official Title
Comparison of Plaque Removal Efficacy of Powered and Manual Toothbrush Among Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Mixed

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Manual Toothbrush.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Powered Toothbrush
Intervention Type
Device
Intervention Name(s)
Manual Toothbrush and Powered Toothbrush
Intervention Description
Manual Toothbrush will be mechanically (hand) driven Powered Toothbrush will be battery operated
Primary Outcome Measure Information:
Title
Oral Hygiene Status assessed by Oral Hygiene Index Simplified (OHI-S)
Description
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)
Time Frame
3 months
Title
Oral Hygiene Status assessed by Gingival Index (GI)
Description
Gingival status will be classified as Mild (0.1-1), Moderate (1.1-2) and Sever (2.1-3)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohsin Haider, BDS
Phone
+923452809676
Email
dr.mohsinhaider@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
madeeha Anwar, BDS
Phone
+923342649392
Email
madeeha.anwar@googlemail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsin Haider, BDS
Organizational Affiliation
Dow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Umeed Rehabilitation Association (AURA)
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75330
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colonel Mecol Ali Shah, Graduate
Phone
+92 334 1124779
Email
info@alumeed.com
First Name & Middle Initial & Last Name & Degree
Fasih Ghori, Graduate
Phone
+92 334 3736065
Email
libra_thegenius@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Plaque Removal Efficacy of Powered and Manual Toothbrush Among Children With Cerebral Palsy

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