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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-05-31

Brief Summary

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* 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.

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Detailed Description

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Conditions

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Tooth Decay Cavities of Teeth Gingivitis Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dental Floss Holders

Dental Floss Holders was constructed.

Group Type EXPERIMENTAL

Dental Floss Holders

Intervention Type DEVICE

Dental Floss Holders for flossing purposes

conventional flossing

conventional flossing to the opposite arch.

Group Type ACTIVE_COMPARATOR

Dental Floss Holders

Intervention Type DEVICE

Dental Floss Holders for flossing purposes

Interventions

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Dental Floss Holders

Dental Floss Holders for flossing purposes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes