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

March 3, 2023 updated by: Mohsin Haider, Dow University of Health Sciences

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75330
        • Recruiting
        • Al Umeed Rehabilitation Association (AURA)
        • Contact:
          • Colonel Mecol Ali Shah, Graduate
          • Phone Number: +92 334 1124779
          • Email: info@alumeed.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. CP Children aged 12-15 years
  2. CP children with OHI-S score >1.3 and GI score >1 & PI score >1
  3. Subjects with positive consent from schools and parents
  4. Presence of at least 20 teeth in the mouth
  5. Independent (mild) CP patients - who are able to perform tooth brushing under supervision assessed by caregiver's account of daily activities.
  6. Mentally stable

Exclusion Criteria:

  1. Inability to cooperate with the oral examination
  2. Severe neuromuscular incoordination
  3. Reluctant or Unable to comprehend consent /or withdrawal of consent
  4. Participant with calculus deposits at baseline
  5. Lack of Manual dexterity to perform oral hygiene
  6. Underlying systemic disease
  7. Participant requiring emergency dental treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
Manual Toothbrush.
Device: Manual Toothbrush and Powered Toothbrush
Manual Toothbrush will be mechanically (hand) driven Powered Toothbrush will be battery operated
Active Comparator: Group II
Powered Toothbrush
Device: Manual Toothbrush and Powered Toothbrush
Manual Toothbrush will be mechanically (hand) driven Powered Toothbrush will be battery operated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Mohsin Haider, BDS, Dow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 5, 2021

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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