A study to compare three different bristle designs of manual toothbrushes in reducing dental plaque in fixed orthodontic patients
| ISRCTN | ISRCTN15086076 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15086076 |
- Submission date
- 11/07/2022
- Registration date
- 14/07/2022
- Last edited
- 11/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Manual toothbrushes play a fundamental role in oral hygiene for preventing dental plaque. Controlling dental plaque accumulation for preventing gum inflammation (gingivitis), gum disease (periodontitis), and tooth decay, is highly influenced by several factors. The presence of fixed orthodontic appliances on tooth surfaces such as brackets and bands creates difficulties in maintaining good oral hygiene, leading to the build-up of plaque. Although there is considerable literature revealing the superiority of powered toothbrushes, particularly oscillating rotating brushes, when compared to manual toothbrushes in patients with fixed orthodontic appliances, there is limited evidence regarding the effectiveness of advanced bristle designs (multilevel, criss-cross) of manual toothbrushes alone in removing plaque on patients undergoing orthodontic treatment except for a few that have compared manual brush with orthodontic brushes with conflicting reports of effectiveness.
This study aims to compare the level of plaque before and after using three different bristle designs of manual toothbrushes in patients undergoing fixed orthodontic treatment.
Who can participate?
Patients being treated with a fully bonded fixed orthodontic appliance, aged between 18 and 25 years, and in good general and oral health.
What does the study involve?
Participants will be allocated to use one of three types of manual toothbrushes (flat, orthodontic, multilevel pulsar) at random, with an equal chance of being allocated each type (like tossing a coin) during the first visit of the study. In the second visit of the study, participants will use one of the two toothbrush types that they did not use in the previous part of the study, again allocated at random. In the third visit of the study, they will use the type of toothbrush they have not yet used. Each visit of the study will be separated by 1 week. Before and after using each type of toothbrush, participants will be assessed for levels of plaque.
What are the possible benefits and risks of participating?
The risks and inconvenience will be very minimal limited to participants sparing some of their valuable time. There will be no individual benefit from participation in this study but it may help in the advancement of knowledge and health science progress.
Where is the study run from?
King Abdullah International Medical Research Center (Saudi Arabia)
When is the study starting and how long is it expected to run for?
From April 2020 to April 2022
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
Dr Fathima Fazrina Farook, fazrinaf@ksau-hs.edu.sa
Contact information
Principal Investigator
King Saud Bin Abdul Aziz University For Health Sciences
KSAU-HS
College of Dentistry
Riyadh
11426
Saudi Arabia
 ORCID ID |
0000-0002-2257-2662 |
|---|---|
| Phone | +966 (0)531051380 |
| fazrinaf@ksau-hs.edu.sa |
Study information
| Study design | Randomized crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A comparative study of three different bristle designs of manual toothbrushes in dental bio-film reduction in fixed orthodontic patients |
| Study objectives | To compare the level of plaque before and after using three different bristle designs of manual toothbrushes (multilevel, flat trim, and orthodontic) in patients undergoing fixed orthodontic treatment using the modified bass technique. |
| Ethics approval(s) | Approved 15/03/2020, Institutional Review Board (IRB) Ministry of National Guard - Health Affairs (King Abdullah International Medical Research Center, Ali Al Arini, Ar Rimayah, Riyadh 11481; +966 (0)114294444; irb@ngha.med.sa), ref: RC20/085/R |
| Health condition(s) or problem(s) studied | Plaque removal in patients with fixed orthodontic appliances |
| Intervention | The study participants will be randomly divided into three treatment sequences using the computer-generating random method ABC, BCA, and CAB with approximately 10 subjects in each treatment sequence. Group A: Toothbrush with flat bristles Group B: Toothbrush with orthodontic bristles Group C: Toothbrush with multilevel (Pulsar) bristles The washout period between each visit will be 1 week |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Plaque score measured using the Turesky Modified Quigley-Hein Plaque Index at baseline and following each single brushing exercise |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/04/2020 |
| Completion date | 01/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 34 |
| Key inclusion criteria | 1. Aged ≥18 to ≤25 years 2. In good general and oral health 3. Wearing fully bonded fixed orthodontic appliances 4. Good hand dexterity 5. Without any disabilities 6. ≥25 natural teeth with facial and lingual scorable surfaces without any oral lesions 7. Periodontal pockets of 3mm or loss of attachment/recession of 2mm |
| Key exclusion criteria | 1. Evidence of mucogingival problems 2. Smoking 3. Pregnancy 4. Five or more carious lesions requiring restorative treatment 5. Heavy restorations 6. Wearing fixed or removable prostheses 7. Participation in any other elective dental procedure, including prophylaxis, during the study period 8. Evidence of any disease or condition that may interfere with the study procedures |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 01/10/2021 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
KSAU-HS
Riyadh
11426
Saudi Arabia
Sponsor information
Government
KSAU-HS
Riyadh
11481
Saudi Arabia
| Phone | +966 (0)114294444 |
|---|---|
| kaimrc-cts@NGHA.MED.SA | |
| Website | http://kaimrc.med.sa/ |
"ROR" |
https://ror.org/009p8zv69 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/11/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request. Dr Fathima Fazrina Farook (fazrinaf@ksau-hs.edu.sa) can be contacted for access to the datasets. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared at the beginning 3 months and ending 5 years following article publication, for individual participant data meta-analysis. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/08/2022 | 11/04/2023 | Yes | No |
Editorial Notes
11/04/2023: Publication reference added.
11/07/2022: Trial’s existence confirmed by Institutional Review Board (IRB) Ministry of National Guard - Health Affairs.
