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

Gingivitis Clinical Trial

Official title:

Plaque Removal Effectiveness of a Flossing Device (Dental Floss Holders) Compared to the Conventional Flossing in Adults: a Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06318819
• Other study ID #: 159-11-19.
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: March 2024
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 26 Years

Eligibility

1. Able to understand, read, and write in Arabic or English and provide written informed consent prior to participation.

2. Not engaged in any other clinical study during the day of examination.

3. Non-smoker and in good general health.

4. Does not have any systemic disease that influences the oral tissue (e.g., diabetes, autoimmune disease, medication/antibiotics).

5. Fully dentate (not including 3rd molars) with established proximal contacts.

6. 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.

7. Does not have any dexterity limitation.

8. Not pregnant at the time of the study.

Related Conditions & MeSH terms

• Cavities of Teeth
• Dental Caries
• Gingivitis
• Plaque
• Tooth Decay

Intervention

Device:
• Dental Floss Holders
Dental Floss Holders for flossing purposes

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University	Jeddah

Sponsors (2)

Lead Sponsor	Collaborator
Maha A. Bahammam	King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental Floss Holders (DFH)	62.8% reduction in whole mouth plaque 63.3% for proximal plaque	6 months
Primary	Conventional flossing (CF)	52.9% reduction in whole mouth plaque and 50.4% for proximal plaque	6 months