The effective brush for patients with orthodontic appliances
| ISRCTN | ISRCTN14766887 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14766887 |
- Submission date
- 03/04/2022
- Registration date
- 09/04/2022
- Last edited
- 12/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The use of manual toothbrushes plays a fundamental role in oral hygiene. However, controlling dental plaque accumulation for preventing gingivitis (gum disease), periodontitis (gum infection), and tooth decay is highly influenced by several individual and material-based factors. Among the individual 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 buildup of plaque. Although there is considerable evidence shwoing the superiority of powered, particularly oscillating rotating brushes when compared to manual brushes in patients with fixed orthodontic appliances, there is limited evidence regarding the effectiveness of advanced bristle designs (multilevel, criss-cross) of the manual toothbrush alone in removing plaque on patients undergoing orthodontic treatment, except for a few that have compared manual brushes with orthodontic brushes with conflicting reports of effectiveness. The aim of this study is to compare the effect of three types of manual toothbrushes (cross-action, flat trim and orthodontic brush) on plaque removal in patients with fixed orthodontic appliances.
Who can participate?
Patients aged 18 to 25 years wearing fixed orthodontic appliances attending the Orthodontic Clinic at the Dental Centre, Ministry of National Guard - Health Affairs
What does the study involve?
Participants will be randomly divided into three treatment sequences (ABC, BCA, CAB):
A: Toothbrush with flat bristles
B: Toothbrush with zigzag bristles
C: Toothbrush with crisscross bristles
Participants attend three clinic visits 1 week apart and at each visit they carry out a single 2-minute brushing exercise with the allocated brush. The clinician will check the participant's plaque before and after the brushing exercise.
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 direct 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 Saud bin Abdulaziz University for Health Sciences (KSAU-HS) (Saudi Arabia)
When is the study starting and how long is it expected to run for?
November 2019 to May 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
College of Dentistry
King Saud bin Abdulaziz University for Health Sciences (KSAU-HS)
Riyadh
11426
Saudi Arabia
 ORCID ID |
0000-0002-2257-2662 |
|---|---|
| Phone | +966 (0)531051380 |
| fazrinaf@ksau-hs.edu.sa |
Study information
| Study design | Randomized cross-over controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Efficacy of manual toothbrushes in patients with fixed orthodontic appliances: a randomized clinical trial |
| Study objectives | To clinically compare the effect of three types of manual toothbrushes (cross-action, flat trim, and orthodontic brush) on plaque removal when the modified Bass method of brushing is used in patients with fixed orthodontic appliances. |
| Ethics approval(s) | Approved 11/12/2019, the King Abdullah International Medical Research Center Institutional Review Board (Ali Al Arini, Ar Rimayah, Riyadh 11481, Saudi Arabia; +966 (0)11 429 4444; irb@ngha.med.sa), ref: RC19/432/R |
| Health condition(s) or problem(s) studied | Plaque removal in patients with fixed orthodontic appliances |
| Intervention | The study subjects (n = 30) will be randomly divided into three treatment sequences using a computer-generated randomisation method (ABC, BCA, CAB) with approximately 10 subjects in each treatment sequence: Group A: Toothbrush with flat bristles Group B: Toothbrush with zigzag bristles Group C: Toothbrush with crisscross bristles Participants attend three clinic visits 1 week apart and at each visit they carry out a single 2-minute brushing exercise with the allocated brush. The clinician will check the plaque before and after the brushing exercise. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | Plaque scored using the Turesky Modified Quigley-Hein Plaque Index at baseline and following a single brushing exercise |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/11/2019 |
| Completion date | 01/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 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. A minimum of 25 natural teeth with facial and lingual scorable surfaces without any oral lesions 7. Periodontal pockets of 3 mm or loss of attachment/recession of 2 mm |
| 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 | 01/11/2020 |
| Date of final enrolment | 01/06/2021 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Riyadh
14611
Saudi Arabia
Sponsor information
Research organisation
Ali Al Arini
Ar Rimayah
Riyadh
11481
Saudi Arabia
| Phone | +966 (0)11 429 4444 |
|---|---|
| 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 | 01/10/2022 |
|---|---|
| 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 | 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 starting 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 | 23/05/2023 | 12/06/2023 | Yes | No |
Editorial Notes
12/06/2023: Publication reference added.
08/04/2022: Trial's existence confirmed by the King Abdullah International Medical Research Center Institutional Review Board.
