Plain English Summary
Background and study aims
Studies have shown that people with intellectual disability (ID) have higher dental plaque levels than the general population, and hence it is justified to look for methods to improve oral health in the ID population. The aim of this study is to find out whether sonic powered toothbrushes provide better clinical outcomes compared to manual tooth brushing in patients with intellectual disability.
Who can participate?
People with limit, mild or moderate ID.
What does the study involve?
Participants were randomly allocated to one of two groups. Participants in both groups were trained and supervised for the first three months in tooth brushing with a fluoride toothpaste. Participants in the test group used a sonic powered toothbrush (Sonicare®, Philips) and participants in the control group used a manual toothbrush.
What are the possible benefits and risks of participating?
Effective toothbrushing will improve dental plaque control, leading to better oral health, including prevention of gum diseases (gingivitis and periodontitis) and tooth decay. There are no risks associated with the study, except for inadequate use of the toothbrush, which can damage teeth and gums.
Where is the study run from?
Carmen Pardo-Valcarce Foundation (Spain).
When is study starting and how long is it expected to run for?
The study duration is expected to be 1 year. Recruitment lasts for about 3 months.
Who is funding the study?
ETEP Research Group (University Complutense, Madrid, Spain).
Who is the main contact?
Prof. David Herrera
davidher@ucm.es
Trial website
Contact information
Type
Scientific
Primary contact
Dr David Herrera
ORCID ID
http://orcid.org/0000-0002-5554-2777
Contact details
Plaza Ramón y Cajal s/n (Ciudad Universitaria)
Madrid
28040
Spain
+34 (0)913 941 907
davidher@odon.ucm.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
362/2013
Study information
Scientific title
Manual versus sonic powered tooth brushing in patients with intellectual disability: a randomised clinical trial
Acronym
Study hypothesis
Sonic powered toothbrushes may provide better clinical outcomes when compared to manual tooth brushing in patients with intellectual disability (since this disability is manifested by diminished practical skills), when used both under supervision or in home-use, after adequate training.
Ethics approval
The regional ethical committee (CEIC Hospital Clínico San Carlos), 07/08/2013, 13/302-E
Study design
Cluster-randomised single-blinded (examiner) clinical trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Condition
Periodontal health
Intervention
Treatment groups
Monitors of the respective support groups were informed of the assignment, and trained before the study (two training sessions with the investigators, with both theoretical and hands-on sessions). The clinical evaluators were not aware of the group assignment or involved in the randomization process. Before the study, no preventive measures for oral health were provided by the monitors, and they depended on the personal private dentists of each participant.
In the test group, tooth brushing was performed with a sonic powered toothbrush (Sonicare EasyClean®, Phillips, Eindhoven, The Netherlands). In the control group, a manual toothbrush was used (Vitis Access®, Dentaid, Barcelona, Spain). When used under supervision, a 2-minute timer per monitor was used. Both groups used the same fluoride toothpaste (FluorAid 250®, Dentaid, Barcelona, Spain) and received written instructions for the use of the toothbrush, requesting not to use antiplaque agents or devices for interdental plaque control during the study. In addition, weekly questionnaires were provided to evaluate compliance, satisfaction or the presence of mechanical problems or adverse effects.
Intervention type
Device
Phase
Drug names
Primary outcome measures
The primary outcome variable was the gingival index (Loe & Silness 1963), which was evaluated at four sites per tooth in two randomly (by coin toss) selected quadrants (one in the upper jaw, one in the lower jaw, contralateral) (Bentley & Disney 1995), by a single calibrated and trained examiner, blinded to the group allocation.
Secondary outcome measures
1. The plaque index (PlI) (Silness & Loe 1964) was evaluated in the same way
2. The presence of calculus (Ccl) was evaluated at the same teeth and sites, dichotomously
3. The presence of adverse effects was assessed by a visual inspection at each study visit
Overall trial start date
01/06/2013
Overall trial end date
30/04/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults from 18 to 65 years
2. Having ID (Schalock et al. 2010) categorized as limit [intelligence quotient (IQ), <70], mild (IQ 50-69), or moderate (35-49)
3. Being part of psychosocial support groups under the supervision of a trained monitor (special educators, with different university degrees in Pedagogy)
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Pregnancy or breastfeeding
2. Less than 18 teeth
3. Orthodontic treatment at the time of recruitment
Recruitment start date
01/09/2013
Recruitment end date
01/09/2013
Locations
Countries of recruitment
Spain
Trial participating centre
Carmen Pardo-Valcarce Foundation
Monasterio de las Huelgas 15
Madrid
28049
Spain
Sponsor information
Organisation
Phillips Oral Healthcare
Sponsor details
22100 Bothell Everett HWY
Bothell WA
98021
United States of America
+1 (0)800 509 7180
namtssc.helpdesk@philips.com
Sponsor type
Industry
Website
Funders
Funder type
University/education
Funder name
Complutense University of Madrid (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
First report "Manual versus sonic powered tooth brushing in patients with intellectual disability: a randomised clinical trial" submitted to a journal in the field of periodontology.
Second report, in preparation, to be submitted to a journal in the field of intellectual disability.
Intention to publish date
15/07/2015
Participant level data
Available on request
Results - basic reporting
Publication summary