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CompletedNCT06318819Updated Mar 20, 2024

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

An interventional study of Dental Floss Holders in Tooth Decay, Cavities of Teeth and Gingivitis, sponsored by Maha A. Bahammam. Completed at 1 site in Saudi Arabia. Open to participants aged 20 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-20.

Sponsored by Maha A. Bahammam · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 4 months after the study started (first participant enrolled Nov 2019, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 26 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Tooth Decay
  • Cavities of Teeth
  • Gingivitis
  • Plaque

Keywords

  • Plaque Removal
  • Flossing Device
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 30 is below the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

This is the only study on the registry with Maha A. Bahammam as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Dental Floss Holders

    Dental Floss Holders was constructed.

    Device: Dental Floss Holders

  • Active comparator
    conventional flossing

    conventional flossing to the opposite arch.

    Device: Dental Floss Holders

Interventions

  • DeviceDental Floss Holders

    Dental Floss Holders for flossing purposes

06

What researchers measure

Primary outcomes

  1. Dental Floss Holders (DFH)

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

    Time frame: 6 months

  2. Conventional flossing (CF)

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

    Time frame: 6 months

07

Study locations

1 site
  • King Abdulaziz University
    Jeddah, Saudi Arabia
08

References and documents

Individual participant data

Plan to share: No — 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. Next, plaque index was recorded again using the O'leary index. Time was recorded during flossing of each arch.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06318819
Lead sponsor
Maha A. Bahammam
Collaborators
King Abdulaziz University
Responsible party
Maha A. Bahammam (Professor, King Abdulaziz University) — Sponsor-investigator
First posted
Mar 19, 2024
Start date
Nov 1, 2019
Primary completion
Mar 15, 2020
Completion
May 31, 2020
Last update
Mar 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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