NCT05768568

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2021

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

September 5, 2021

Last Update Submit

March 3, 2023

Conditions

Cerebral Palsy, Mixed

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    3 months

Study Arms (2)

Group I

ACTIVE COMPARATOR

Manual Toothbrush.

Device: Manual Toothbrush and Powered Toothbrush

Group II

ACTIVE COMPARATOR

Powered Toothbrush

Device: Manual Toothbrush and Powered Toothbrush

Interventions

Manual Toothbrush and Powered ToothbrushDEVICE

Manual Toothbrush will be mechanically (hand) driven Powered Toothbrush will be battery operated

Group IGroup II

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Umeed Rehabilitation Association (AURA)

Karachi, Sindh, 75330, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mohsin Haider, BDS

    Dow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohsin Haider, BDS

CONTACT

+923452809676dr.mohsinhaider@yahoo.com

madeeha Anwar, BDS

CONTACT

+923342649392madeeha.anwar@googlemail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2021

First Posted

March 14, 2023

Study Start

April 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)