Tooth DecayNCT06318819
Plaque Removal Effectiveness of a Flossing Device Compared to the Conventional Flossing in Adults
A study testing Dental Floss Holders in people with Tooth Decay and Cavities of Teeth, run by Maha A. Bahammam at 1 site in Saudi Arabia.
Trial summary
Objective: To evaluate the effectiveness in plaque removal of the new device; Dental floss holders and compare the results to the conventional way of flossing. Methods: Thirty adult male and female participants participated in this randomized, single-use, single-blind clinical study. Read more about this study
- Who is it for?
- Ages 20 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Decay, Cavities of Teeth, Gingivitis
- What is being tested?
- Dental Floss Holders
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Nov 2019to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
- Able to understand, read, and write in Arabic or English and provide written informed consent prior to participation.
- Not engaged in any other clinical study during the day of examination.
- Non-smoker and in good general health.
- Does not have any systemic disease that influences the oral tissue (e.g., diabetes, autoimmune disease, medication/antibiotics).
- Fully dentate (not including 3rd molars) with established proximal contacts.
- Good oral health with no hard or soft tissue lesions, no gross caries, no probing depths greater than 4 mm, no obvious advanced periodontal disease, no fixed orthodontic appliances, nor removable partial dentures.
- Does not have any dexterity limitation.
- Not pregnant at the time of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plaque Removal Effectiveness of a Flossing Device (Dental Floss Holders) Compared to the Conventional Flossing in Adults: a Randomized Clinical Trial.
- Objective: To evaluate the effectiveness in plaque removal of the new device; Dental floss holders and compare the results to the conventional way of flossing.
- Methods: Thirty adult male and female participants participated in this randomized, single-use, single-blind clinical study. Participants were randomly assigned to one of two groups; Group A: Consists of 30 participants in whom Dental Floss Holders (DFH) was constructed to either maxillary or mandibular arch randomly. Group B: Consists of 30 participants in whom conventional flossing (CF) was done to the other arch.
Participants attended the first visit for primary impression taking in order to construct the DFH. In the second visit, participants were examined by a blinded examiner to record their plaque index using O'Leary index. Then, they flossed using DFH and CF according to the group they were assigned to. Participants were monitored to ensure proper coverage of all the areas following precise instructions. They then brushed their teeth for approximately 2 minutes using modified bass technique. Next, plaque index was recorded again using the O'leary index. Time was recorded during flossing of each arch. Finally, participants were given a questionnaire to assess their satisfaction of the device.
- Results: The differences between the groups showed the DFH group with a 62.8% reduction in whole mouth plaque and 63.3% for proximal plaque compared to 52.9% and 50.4% for the CF group, respectively (p = 0.01). The DFH was more time efficient in removing plaque from the marginal regions with an average time of 00:00:37 in comparison to the CF which averaged in 00:02:07 (p < 0.001). A total of 26 participants (86.7%) preferred using the DFH over the CF.
- Conclusion: With the combination of toothbrushing, the Dental Floss Holders is significantly more effective and time efficient than conventional flossing in removing plaque from tooth surfaces.
- Conditions
- Tooth Decay, Cavities of Teeth, Gingivitis, Plaque
- Being tested
- Dental Floss Holders
- Keywords
- Plaque Removal, Flossing Device
- Medical subject headings
- Dental Caries, Gingivitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Floss HoldersDevice
Dental Floss Holders for flossing purposes
| Study group | Role | What they receive |
|---|---|---|
| Dental Floss Holders | Experimental | Dental Floss Holders was constructed. Receives: Device: Dental Floss Holders |
| conventional flossing | Active comparator | conventional flossing to the opposite arch. Receives: Device: Dental Floss Holders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Floss Holders (DFH)
62.8% reduction in whole mouth plaque 63.3% for proximal plaque
Measured: 6 months
Conventional flossing (CF)
52.9% reduction in whole mouth plaque and 50.4% for proximal plaque
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Nov 2019
- Primary completion15 Mar 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DecayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maha A. Bahammam
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdulaziz University
- Responsible party
- Sponsor-investigator, Maha A. Bahammam, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318819
- Sponsor's protocol ID
- 159-11-19.
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Thirty adult male and female participants participated in this randomized, single-use, single-blind clinical study. Participants were randomly assigned to one of two groups; Group A: Consists of 30 participants in whom Dental Floss Holders (DFH) was constructed to either maxillary or mandibular arch randomly. Group B: Consists of 30 participants in whom conventional flossing (CF) was done to the other arch. Participants attended the first visit for primary impression taking in order to construct the DFH. In the second visit, participants were examined by a blinded examiner to record their plaque index using O'Leary index. Then, they flossed using DFH and CF according to the group they were assigned to. Next, plaque index was recorded again using the O'leary index. Time was recorded during flossing of each arch.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Removal Effectiveness of a Flossing Device (Dental Floss Holders) Compared to the Conventional Flossing in Adults: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06318819
- Acronym / sponsor ID
- 159-11-19.
- Conditions
- Tooth Decay, Cavities of Teeth, Gingivitis, Plaque
- Keywords
- Plaque Removal, Flossing Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maha A. BahammamUniversity, hospital or other
- Collaborators
- King Abdulaziz University
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Objective: To evaluate the effectiveness in plaque removal of the new device; Dental floss holders and compare the results to the conventional way of flossing.
- Methods: Thirty adult male and female participants participated in this randomized, single-use, single-blind clinical study. Participants were randomly assigned to one of two groups; Group A: Consists of 30 participants in whom Dental Floss Holders (DFH) was constructed to either maxillary or mandibular arch randomly. Group B: Consists of 30 participants in whom conventional flossing (CF) was done to the other arch.
Participants attended the first visit for primary impression taking in order to construct the DFH. In the second visit, participants were examined by a blinded examiner to record their plaque index using O'Leary index. Then, they flossed using DFH and CF according to the group they were assigned to. Participants were monitored to ensure proper coverage of all the areas following precise instructions. They then brushed their teeth for approximately 2 minutes using modified bass technique. Next, plaque index was recorded again using the O'leary index. Time was recorded during flossing of each arch. Finally, participants were given a questionnaire to assess their satisfaction of the device.
- Results: The differences between the groups showed the DFH group with a 62.8% reduction in whole mouth plaque and 63.3% for proximal plaque compared to 52.9% and 50.4% for the CF group, respectively (p = 0.01). The DFH was more time efficient in removing plaque from the marginal regions with an average time of 00:00:37 in comparison to the CF which averaged in 00:02:07 (p < 0.001). A total of 26 participants (86.7%) preferred using the DFH over the CF.
- Conclusion: With the combination of toothbrushing, the Dental Floss Holders is significantly more effective and time efficient than conventional flossing in removing plaque from tooth surfaces.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental Floss Holders | Experimental | Device: Dental Floss HoldersDental Floss Holders was constructed. |
| conventional flossing | Active comparator | Device: Dental Floss Holdersconventional flossing to the opposite arch. |
Who may qualify
- Ages
- 20 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental Floss HoldersDental Floss Holders for flossing purposes | Device | Dental Floss Holders, conventional flossing |
Primary outcome
Dental Floss Holders (DFH)
Time frame: 6 months
62.8% reduction in whole mouth plaque 63.3% for proximal plaque
Conventional flossing (CF)
Time frame: 6 months
52.9% reduction in whole mouth plaque and 50.4% for proximal plaque
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No. Thirty adult male and female participants participated in this randomized, single-use, single-blind clinical study. Participants were randomly assigned to one of two groups; Group A: Consists of 30 participants in whom Dental Floss Holders (DFH) was constructed to either maxillary or mandibular arch randomly. Group B: Consists of 30 participants in whom conventional flossing (CF) was done to the other arch. Participants attended the first visit for primary impression taking in order to construct the DFH. In the second visit, participants were examined by a blinded examiner to record their plaque index using O'Leary index. Then, they flossed using DFH and CF according to the group they were assigned to. Next, plaque index was recorded again using the O'leary index. Time was recorded during flossing of each arch.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Floss Holders in people with Tooth Decay and Cavities of Teeth, run by Maha A. Bahammam at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Floss Holders (DFH) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.