NCT04081311

A Comparison of the Efficacy of Interdental Floss to Water Flosser Around Dental Implants

A Comparison of the Efficacy of Interdental Floss to Water Flosser Around Dental Implants in Maintenance Patients: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study was to compare two different interproximal devices, water flosser and dental floss around implants in several clinical parameters

Detailed description

This study was a randomized, controlled clinical trial in a single center. All clinical measurements were taken by a single blinded investigator (Periodontal Resident) while a single dental hygienist was responsible for prophylaxis and delivery of oral hygiene instructions to the study participants. At each appointment 5 clinical parameters were recorded: Full Mouth Plaque Score (FMPS) and Quigley-Hein plaque index (QHI) of the implants after the use of a disclosing solution, Probing Depth (PD), Bleeding on Probing (BOP) of the study implants recorded at 6 sites (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual and mesiolingual) using a UNC 12 Colorvue probe and the width of the keratinized tissue (KT) at the buccal surface of the study implants. Randomization between the 2 groups was achieved using computerized randomization scheme (https://en.calc-site.com/randoms/grouping). Group A (control): patients were instructed to floss with TePe Bridge and Implant Floss once a day, preferably at nighttime. Group B (test): patients were provided with Waterpik Water Flosser and instructed to water floss around the implant once a day, preferably at nighttime. During each appointment the study investigator measured clinical parameters and participants received oral hygiene instructions (OHI) and supportive periodontal therapy (SPT) by a single dental hygienist. Once the study was concluded patients were asked to fill-out a 2 question questionnaire inquiring how much they liked their interproximal device and how easy it was to be used in a scale 1 to 5.

Conditions

• Implant Site Bleeding

Interventions

Type	Name	Description
DEVICE	comparing interdental floss to water flosser around dental implants	to determine the effectiveness in reducing the bleeding on probing (BOP) index around dental implants

Timeline

• Start date: 2019-09-06
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2019-09-09
• Last updated: 2021-04-30

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study