Clinical trial NCT06318819: Plaque Removal Effectiveness of a Flossing Device Compared to the Conventional Flossing in Adults
Official title: Plaque Removal Effectiveness of a Flossing Device (Dental Floss Holders) Compared to the Conventional Flossing in Adults: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Decay
Cavities of Teeth
Gingivitis
Plaque
Keywords: Plaque Removal
Flossing Device
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
Collaborators: name: King Abdulaziz University
First posted: 2024-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dental Floss Holders (DFH)
timeFrame: 6 months
measure: Conventional flossing (CF)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
Study officials:
References: