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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	H-01-R-059
Sponsor	Princess Nourah bint Abdulrahman University
Funder	Princess Nourah Bint Abdulrahman University

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Eman Alsagob
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
Email	EIALSAGOB@pnu.edu.sa

Study information

Primary study design	Interventional
Study design	Single-blind randomized controlled parallel clinical trial with a split-mouth protocol
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Super-Floss® (Oral-B), Waterpik® water flosser
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	01/01/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	35 Years
Sex	All
Target sample size at registration	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

Riyadh Specialized Dental Center

Imam Abdullah Bin Saud Ibn Abdulaziz RD
Ishbiliyah
Riyadh
13226
Saudi Arabia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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?
Results article		31/08/2022	13/09/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file			09/09/2021	No	No

Additional files

40318 Protocol.pdf: Protocol file

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.