Effectiveness of Super-Floss® (Oral-B) and the Waterpik® water flosser in plaque removal for patients undergoing orthodontic treatment
| ISRCTN | ISRCTN83875016 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83875016 |
| Secondary identifying numbers | H-01-R-059 |
- Submission date
- 23/08/2021
- Registration date
- 12/09/2021
- Last edited
- 13/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Patients who wear fixed orthodontic appliances must maintain high standards of oral hygiene; otherwise, they will experience a range of complications.
Various devices are available to help orthodontic patients maintain good oral hygiene, including essential manual toothbrushes and toothpaste, electronic toothbrush, dental floss, brushes for interproximal hygiene, and oral irrigators, such as dental water floss.
This trial aimed to evaluate the effectiveness of super floss (Oral-B Super Floss) and water flosser (Waterpik Cordless Freedom Water Flosser) in plaque removal in orthodontic patients.
Who can participate?
Male or female between 18-35 years old who are approaching the end of their orthodontic treatment
What does the study involve?
Super-Floss ® (Oral-B) will be used on one side of the mouth, while the Waterpik® water flosser will be used on the other. All participants will have around two minutes to brush their teeth and another two minutes to clean in between their teeth.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Princess Nourah Bint Abdulrahman University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
October 2018 to January 2021
Who is funding the study?
Deanship of Scientific Research at Princess Nourah Bint Abdulrahman University (Saudi Arabia)
Who is the main contact?
Dr. Eman Alsagob, EIALSAGOB@pnu.edu.sa
Contact information
Scientific
Preventive Dental Sciences Department
College of Dentistry
Princess Nourah bint Abdulrahman University
Riyadh
13414
Saudi Arabia
 ORCID ID |
0000-0002-3206-3167 |
|---|---|
| Phone | +966 555 178 877 |
| EIALSAGOB@pnu.edu.sa |
Study information
| Study design | Single-blind randomized controlled parallel clinical trial with a split-mouth protocol |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Comparison between the effectiveness of dental floss and water floss in plaque removal: a controlled clinical trial in orthodontic patients |
| Study objectives | Studies investigating the efficacy of dental water floss on oral hygiene control of orthodontic patients are limited, and its impact on reducing supragingival plaque biofilm remains unclear. This determines the need for studying the effect of this device on an orthodontic patient sample in particular and whether it is superior or as effective compared to super floss. Hence, this randomized control trial aimed to evaluate the effectiveness of super floss (Oral-B Super Floss) and water flosser (Waterpik Cordless Freedom Water Flosser) in plaque removal in orthodontic patients. |
| Ethics approval(s) | The study was reviewed and exempted on 01/10/2018, by the Institutional Review Board (IRB) of Princess Nourah Bint Abdulrahman University (Riyadh, Saudi Arabia; +966118240861; irb@pnu.edu.sa), ref: IRB:18-0241 |
| Health condition(s) or problem(s) studied | Removal of dental plaque in orthodontic patients |
| Intervention | In a single visit, the split-mouth technique is performed to compare consistency in both groups. In addition, RMNPI is adapted to measure plaque levels of all subjects at baseline with the use of the WHO probe. A separate researcher will explain oral hygiene instructions to all subjects, using the modified bass technique and a standard toothbrush (soft-bristled brush with fluoridated toothpaste) and explain to the patients the correct method of using interdental cleaning techniques manufacturer’s instructions. The type of floss used will be randomly assigned to each side of the oral cavity; Super-Floss ® (Oral-B) will be used on one side, while the Waterpik® water flosser will be used on the other. All participants will have around two minutes to brush their teeth and another two minutes to clean their interproximal teeth. There was no follow up period. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Super-Floss® (Oral-B), Waterpik® water flosser |
| Primary outcome measure | The plaque index of each side will be taken before and after the intevention. Examiners who are recording the plaque index before and after the trial will be blinded regarding the type of floss used for each side of the mouth). Respectively, a canine, one premolar, and one molar are selected for evaluation. Plaque is assessed for each tooth area and is scored using the following scale: 0 = absent, and 1 = present. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/10/2018 |
| Completion date | 01/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Both |
| Target number of participants | 62 |
| Total final enrolment | 34 |
| Key inclusion criteria | 1. Male or female between 18-35 years 2. Approaching the end of their orthodontic treatment 3. Undergoing braces from the right first molar to the left first molar with pocket depth ≤3mm 4. Not used any floss type for the last 24 hours |
| Key exclusion criteria | 1. Systemic diseases 2. Craniofacial anomalies 3. Periodontal problems 4. Spacing or missing teeth in the examined arch 5. Smokers |
| Date of first enrolment | 01/02/2019 |
| Date of final enrolment | 01/05/2019 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Ishbiliyah
Riyadh
13226
Saudi Arabia
Sponsor information
University/education
Airport Road
King Khalid International Airport
Riyadh
11564
Saudi Arabia
| Phone | +966 11 822 0000 |
|---|---|
| info@pnu.edu.sa | |
| Website | https://www.pnu.edu.sa/en/pages/home.aspx |
"ROR" |
https://ror.org/05b0cyh02 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Princess Nora University, Princess Nora Bint Abdulrahman University, PNU
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 31/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 09/09/2021 | No | No | ||
| Results article | 31/08/2022 | 13/09/2022 | Yes | No |
Additional files
Editorial Notes
13/09/2022: Publication reference added.
10/01/2022: The following changes have been made:
1. The target number of participants has been changed from 34 to 62.
2. The intention to publish date has been changed from 31/01/2022 to 31/03/2022.
09/09/2021: Trial's existence confirmed by Institutional Review Board (IRB) of Princess Nourah Bint Abdulrahman University.
