Condition category
Digestive System
Date applied
05/07/2015
Date assigned
24/07/2015
Last edited
24/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes