Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial

Dental Plaque Clinical Trial

Official title:

Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114801
• Other study ID #: 358.350/2013
• Status: Completed
• Phase: N/A
• First received: March 20, 2014
• Last updated: April 11, 2014
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: Federal University of the Valleys of Jequitinhonha and Mucuri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The aim of the present study was to determine the effectiveness of brushing with an electric toothbrush switched on and switched off in comparison to manual brushing for the removal of dental plaque in children aged four to 16 years with cerebral palsy.

Description:

Advances in the design and type of movement of electric toothbrushes can determine the increase in effectiveness in the control of biofilm by caregivers and patients.There is a paucity of studies evaluating the effectiveness of the electric toothbrush compared to manual toothbrush specifically in patients with cerebral palsy.Only one study used the electric toothbrush in patients with cerebral palsy and demonstrated superiority of the electric toothbrush over the manual. However, the study investigated the effect of various cleaning strategies on symptoms of gingival inflammation, not specifically focusing on the comparison of the efficiency of removal of biofilm from the manual toothbrush and electric toothbrush. The primary objective of this study was to evaluate the effectiveness of the electric brush on and off the removal of dental plaque in subjects with cerebral palsy compared to manual toothbrush. The secondary objective was to characterize the study as socioeconomic population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

Inclusion Criteria:

• medical diagnosis of cerebral palsy

Exclusion Criteria:

• who did not complete the cycle three brushings

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy;
• Dental Plaque

Intervention

Device:
• manual brushing
Tooth brushing
• electric toothbrush linked
Tooth brushing
• off electric toothbrush
Tooth brushing

Locations

Country	Name	City	State
Brazil	Universidade Federal dos Vales do Jequitinhonha e Mucuri	Diamantina	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of the Valleys of Jequitinhonha and Mucuri

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removal of dental plaque	Before and after brushings were assessed levels of plaque accumulation. For evaluation of the dental plaque index of Quigley-Hein plaque modified Turesky was used.; The escovções were performed by caregivers.	after brushing three minutes duration	No