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

NCT06318819 | Completed

• 1 other identifier: 159-11-19.
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Decay; Cavities of Teeth; Gingivitis; Plaque

Keywords

Plaque Removal; Flossing Device

Outcome Measures

Primary Outcomes (2)

• Dental Floss Holders (DFH)

  62.8% reduction in whole mouth plaque 63.3% for proximal plaque

  6 months

• Conventional flossing (CF)

  52.9% reduction in whole mouth plaque and 50.4% for proximal plaque

  6 months

Study Arms (2)

Dental Floss Holders

EXPERIMENTAL

Dental Floss Holders was constructed.

Device: Dental Floss Holders

conventional flossing

ACTIVE COMPARATOR

conventional flossing to the opposite arch.

Device: Dental Floss Holders

Interventions

Dental Floss Holders DEVICE

Dental Floss Holders for flossing purposes

Dental Floss Holders; conventional flossing

Eligibility Criteria

• Age: 20 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Maha A. Bahammam: lead
• King Abdulaziz University: collaborator

Study Sites (1)

King Abdulaziz University

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Dental Caries; Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: November 1, 2019
• Primary Completion: March 15, 2020
• Study Completion: May 31, 2020
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)