Plaque Removal Effectiveness of a Flossing Device Compared to

Status Completed

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06318819
Study type	Interventional
Source	King Abdulaziz University
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2019
Completion date	May 31, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms