Comparing the efficacy of oral irrigator and dental floss in removal of dental plaque after single-use
| ISRCTN | ISRCTN32594597 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32594597 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | HAPO-02-K-012-2023-10-1783 |
- Submission date
- 01/11/2024
- Registration date
- 20/11/2024
- Last edited
- 15/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Gingivitis and dental caries are common diseases caused by dental plaque, which can build up between teeth even with regular brushing. Interdental cleaning tools like dental floss and oral irrigators can help remove this plaque. However, many people find flossing difficult due to the manual dexterity required. Oral irrigators are easier to use and may be more effective. This study aims to compare the effectiveness of dental floss and oral irrigators in removing plaque and to evaluate how well participants can use these tools.
Who can participate?
Patients attending Um Al-Qura University Teaching Hospital who are 18 years or older and willing to sign a consent form.
What does the study involve?
Participants will clean their teeth using both dental floss and an oral irrigator. They will be randomly assigned to use one tool on one side of their mouth and the other tool on the other side. Before the study visit, participants will be asked not to brush their teeth or use any floss for 6-8 hours. An examiner will measure plaque levels before and after cleaning.
What are the possible benefits and risks of participating?
Participants will get to try both dental floss and an oral irrigator, helping them find the best method for their oral hygiene. They will also receive instructions on proper use and learn more about the importance of flossing. There are no significant risks involved.
Where is the study run from?
The study is conducted at the Faculty of Dentistry at the University of Umm Al-Qura in Saudi Arabia.
When is the study starting and how long is it expected to run for?
July 2023 to March 2024
Who is funding the study?
The study is initiated and funded by the investigators.
Who is the main contact?
Wjood Sharkar (s442009768@uqu.edu.sa, Wojoudsharkar@gmail.com)
Dr Afnan Nassar (aanassar@uqu.edu.sa)
Contact information
Principal Investigator
Umm Al-Qura University
Makkah
24352
Saudi Arabia
| Phone | +966 55 338 5532 |
|---|---|
| amharrandah@uqu.edu.sa |
Public, Scientific
Saudi Arabia, Makkah
Makkah
24232
Saudi Arabia
 ORCID ID |
0009-0000-8483-7024 |
|---|---|
| Phone | +966 547221391 |
| s442009768@uqu.edu.sa |
Public, Scientific, Principal Investigator
Umm Al-Qura University
Makkah
24352
Saudi Arabia
| Phone | +966 (0)506378234 |
|---|---|
| aanassar@uqu.edu.sa |
Study information
| Study design | Randomized controlled clinical trial with a single-blinded and a split-mouth design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Prevention, Treatment |
| Participant information sheet | 46327_PIS_InformedConsent_v1.0.pdf |
| Scientific title | Comparing the efficacy of oral irrigator and dental floss in removal of dental plaque after single-use: a split-mouth study design |
| Study objectives | There is no significant difference between the efficacy of dental floss and oral irrigator in plaque removal. |
| Ethics approval(s) |
Approved 11/10/2023, Institutional Research Ethics Board (IRB): Biomedical research ethics committee (Umm Al-Qura University, Makkah, 24352, Saudi Arabia; +966 (0)125270000; irb.uqudent@uqu.edu.sa), ref: HAPO-02-K-012-2023-10-1783 |
| Health condition(s) or problem(s) studied | Prevention of gingivitis and dental caries |
| Intervention | Eighty-five participants were recruited and asked not to brush their teeth and not to use any type of floss 6-8 hours before the visit. DMFS score, gingival index, staining, and calculus were assessed to evaluate the participant’s oral health. The participants were thoroughly instructed on using both aids through detailed video tutorials. Additionally, an examiner closely observed the participants during the performances and provided hands-on guidance to ensure they were using the aids correctly. Participants randomly decided on which side they would use dental floss (Oral B) and on which side they would use the oral irrigator (Waterpik Cordless Plus Water Flosser), both aids were used by the participants themselves. Sillness and Loe plaque scores were recorded before and after the performances by an examiner who was blinded to which method was used for which side. For inter-comparison and intra-comparison, a t-test was used, and a p-value of ≤0.05 was assessed to be statistically significant. Each intervention was conducted during a single visit, with each visit lasting approximately 25 minutes. There was no follow-up required for participants after the intervention; however, there was a 15-minute interval between the pre- and post-intervention plaque assessments. The duration taken by each participant for the intervention itself was 5 minutes. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dental Floss, Oral Irrigator |
| Primary outcome measure | 1. Dental plaque is measured using the Sillness and Loe plaque index at baseline 2. Dental plaque is measured using the Sillness and Loe plaque index after cleaning with an oral irrigator 3. Dental plaque is measured using the Sillness and Loe plaque index after cleaning with dental floss |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 17/07/2023 |
| Completion date | 14/03/2024 |
Eligibility
| Participant type(s) | Patient, Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | The required minimum number of participants was 35 in each group, for a total of 70 participants. |
| Total final enrolment | 85 |
| Key inclusion criteria | 1. Adult (18 - 65 years old) 2. Visiting Um Al-qura Teaching Hospital 3. Able to watch video tutorials and comprehend live instructions 4. Agree to participate in the intervention and answer all the questionnaires. 5. Didn’t use any type of floss or brush their teeth 6-8 hours prior to the trial |
| Key exclusion criteria | Does not meet the previous inclusion criteria, also: 1. Who didn’t complete the given questionnaire 2. Did not approve to participate in the trial and did not sign the consent form. |
| Date of first enrolment | 27/11/2023 |
| Date of final enrolment | 14/03/2024 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
24352
Saudi Arabia
Sponsor information
Research organisation
Institutional Research Ethics Board
Makkah
24352
Saudi Arabia
| Phone | +966 125280347 |
|---|---|
| irb.uqudent@uqu.edu.sa | |
| Website | https://uqu.edu.sa/en/pharmcol/1500 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Dr. Afnan Nassar, Umm Al-Qura University, Faculty of Dentistry, Saudi Arabia. SPSS file (unidentified) The data will be available upon request for two years. Data can be accessed by the journal to which we will submit our article, any Saudi Governmental authority, researchers after careful consideration of their scientific intention to use. All data are anonymous with no identification |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 15/11/2024 | No | No | ||
| Participant information sheet | version 1.0 | 15/11/2024 | No | Yes |
Additional files
Editorial Notes
01/11/2024: Trial's existence confirmed by Institutional Research Ethics Board (IRB): Biomedical research ethics committee.
