Manual versus sonic powered tooth brushing in patients with intellectual disability (Cepillado manual versus cepillado eléctrico para la salud oral en pacientes con discapacidad intelectual leve y moderada)
| ISRCTN | ISRCTN16336355 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16336355 |
| Secondary identifying numbers | 362/2013 |
- Submission date
- 05/07/2015
- Registration date
- 24/07/2015
- Last edited
- 16/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Plaza Ramón y Cajal s/n (Ciudad Universitaria)
Madrid
28040
Spain
 ORCID ID |
0000-0002-5554-2777 |
|---|---|
| Phone | +34 (0)913 941 907 |
| davidher@odon.ucm.es |
Study information
| Study design | Cluster-randomised single-blinded (examiner) clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Scientific title | Manual versus sonic powered tooth brushing in patients with intellectual disability: a randomised clinical trial |
| Study objectives | 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(s) | The regional ethical committee (CEIC Hospital Clínico San Carlos), 07/08/2013, 13/302-E |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/06/2013 |
| Completion date | 30/04/2014 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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) |
| Key exclusion criteria | 1. Pregnancy or breastfeeding 2. Less than 18 teeth 3. Orthodontic treatment at the time of recruitment |
| Date of first enrolment | 01/09/2013 |
| Date of final enrolment | 01/09/2013 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
28049
Spain
Sponsor information
Industry
22100 Bothell Everett HWY
Bothell WA
98021
United States of America
| Phone | +1 (0)800 509 7180 |
|---|---|
| namtssc.helpdesk@philips.com | |
"ROR" |
https://ror.org/03kw6wr76 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Complutense University of Madrid, UCM
- Location
- Spain
Results and Publications
| Intention to publish date | 15/07/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2016 | 23/01/2019 | Yes | No |
Editorial Notes
16/01/2020: Internal review.
23/01/2019: Publication reference added.
