Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05768568 |
| Other study ID # |
MH21 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2023 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Dow University of Health Sciences |
| Contact |
Mohsin Haider, BDS |
| Phone |
+923452809676 |
| Email |
dr.mohsinhaider[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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
