NCT06318819

Plaque Removal Effectiveness of a Flossing Device Compared to the Conventional Flossing in Adults

Completed NA Last updated 20 March 2024

What this trial tests

NA trial testing Dental Floss Holders in Tooth Decay in 30 participants. Completed in 31 May 2020.

Timeline

1 November 2019

Primary endpoint
15 March 2020

31 May 2020

Quick facts

Lead sponsor	Maha A. Bahammam
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	30
Start date	1 November 2019
Primary completion	15 March 2020
Estimated completion	31 May 2020
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• Dental Floss Holders

Conditions studied

• Tooth Decay — all drugs for Tooth Decay →
• Cavities of Teeth — all drugs for Cavities of Teeth →
• Gingivitis — all drugs for Gingivitis →
• Plaque — all drugs for Plaque →

Sponsor

Maha A. Bahammam

Who can join

Adults 20 to 26, any sex, with Tooth Decay or Cavities of Teeth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.