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

Not Applicable

Completed

• Conditions: Tooth Decay; Cavities of Teeth; Gingivitis; Plaque
• Interventions: Device: Dental Floss Holders

• Registration Number: NCT06318819
• Lead Sponsor: Maha A. Bahammam

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2020-03-15
• Study Completion: 2020-05-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-19
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional flossing	Dental Floss Holders	conventional flossing to the opposite arch.
Dental Floss Holders	Dental Floss Holders	Dental Floss Holders was constructed.

Primary Outcome Measures

Name	Time	Method
Conventional flossing (CF)	6 months	52.9% reduction in whole mouth plaque and 50.4% for proximal plaque
Dental Floss Holders (DFH)	6 months	62.8% reduction in whole mouth plaque 63.3% for proximal plaque

Trial Locations

Locations (1)

King Abdulaziz University; 🇸🇦 Jeddah, Saudi Arabia