protocolSection identificationModule nctId: NCT06318819, orgStudyIdInfo id: 159-11-19., briefTitle: Plaque Removal Effectiveness of a Flossing Device Compared to the Conventional Flossing in Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-11-01, primaryCompletionDateStruct date: 2020-03-15, completionDateStruct date: 2020-05-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Maha A. Bahammam, class: OTHER, collaborators name: King Abdulaziz University, descriptionModule briefSummary: * 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., conditionsModule conditions: Tooth Decay, conditions: Cavities of Teeth, conditions: Gingivitis, conditions: Plaque, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Dental Floss Holders, outcomesModule primaryOutcomes measure: Dental Floss Holders (DFH), primaryOutcomes measure: Conventional flossing (CF), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 26 Years, stdAges: ADULT, contactsLocationsModule locations facility: King Abdulaziz University, city: Jeddah, country: Saudi Arabia, geoPoint lat: 21.54238, lon: 39.19797, hasResults: False