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

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

Study Overview

• Status: Completed
• Conditions: Implant Site Bleeding
• Intervention / Treatment: Device: comparing interdental floss to water flosser around dental implants

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0W2
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients that present with at least a single implant with a screw-retained crown
• Patients with general good health that do not have a condition contra-indicating routine dental treatment
• Patients that are compliant with the research protocol and methods
• Patients that have read, understood and signed the informed consent form

Exclusion Criteria:

• Patients with implants with cemented crowns
• Patients with any contact hypersensitivity to the related materials used in the study
• Tobacco users (vaping included)
• Patients unwilling to sign the informed consent form or follow the protocol of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: water flosser; patient will be provided with Waterpik Water Flosser and instructed to water floss around the implant once a day, preferably at nighttime	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
ACTIVE_COMPARATOR: dental floss; patient will be instructed to floss with TePe Bridge and Implant Floss once a day, preferably at nighttime	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BOP (bleeding on probing) index around dental implants	to determine the effectiveness of a waterfloss system compared to flossing in changing the bleeding on probing (BOP) index around dental implants. BOP is a sign of inflammation and is recorded as yes/no (yes for bleeding, no for absence of bleeding). BOP is a percentage calculated by dividing the number of bleeding sites divided by the total number of sites of each implant. A lower percentage indicates lower inflammation	All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
Full Mouth Plaque Score (FMPS)	to determine the differences between water flosser compared to flossing in changing the Full Mouth Plaque Score (FMPS). FMPS is a percentage calculated by dividing the number of plaque containing surfaces divided by the total number of available surfaces of each tooth/implant. A lower percentage indicates lower total plaque and means better plaque control	All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
Quigley-Hein plaque index (QHI) around dental implants	to determine the differences of a waterfloss system compared to flossing in (QHI) around dental implants. Quigley-Hein plaque index (QHI) is a scale 0 to 5. 0 no plaque.; separate flecks of plaque at the cervical margin of the tooth.; a thin continuous band of plaque (up to one mm) at the cervical margin of the tooth.; a band of plaque wider than one mm but covering less than one-third of the crown of the tooth.; plaque covering at least one-third but less than two-thirds of the crown of the tooth.; plaque covering two-thirds or more of the crown of the tooth. A lower number indicates better plaque control.	All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
keratinized tissue (KT) around dental implants	to evaluate the differences of a waterfloss system compared to flossing in the width of keratinized tissue (KT) around dental implants. KT is the stratified, squamous epithelium, that lines the vestibular and oral surfaces of the gingiva.	All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
Probing Depth (PD) around dental implants	to evaluate the differences of a waterfloss system compared to flossing in Probing Depth (PD) around dental implants. PD is the measurement of the depth of a sulcus by measuring in millimeters the distance from a gingival margin to the base of the sulcus with a calibrated periodontal probe.	All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)

Collaborators and Investigators

• Sponsor: University of Manitoba

Publications and helpful links

General Publications

• Testori T, Del Fabbro M, Feldman S, Vincenzi G, Sullivan D, Rossi R Jr, Anitua E, Bianchi F, Francetti L, Weinstein RL. A multicenter prospective evaluation of 2-months loaded Osseotite implants placed in the posterior jaws: 3-year follow-up results. Clin Oral Implants Res. 2002 Apr;13(2):154-61. doi: 10.1034/j.1600-0501.2002.130205.x.
• van Velzen FJ, Lang NP, Schulten EA, Ten Bruggenkate CM. Dental floss as a possible risk for the development of peri-implant disease: an observational study of 10 cases. Clin Oral Implants Res. 2016 May;27(5):618-21. doi: 10.1111/clr.12650. Epub 2015 Aug 11.
• Montevecchi M, De Blasi V, Checchi L. Is Implant Flossing a Risk-Free Procedure? A Case Report with a 6-year Follow-up. Int J Oral Maxillofac Implants. 2016 May-Jun;31(3):e79-83. doi: 10.11607/jomi.4263.
• Worthington HV, MacDonald L, Poklepovic Pericic T, Sambunjak D, Johnson TM, Imai P, Clarkson JE. Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries. Cochrane Database Syst Rev. 2019 Apr 10;4(4):CD012018. doi: 10.1002/14651858.CD012018.pub2.
• Kelekis-Cholakis A, Rothney J. Maintenance of Implant Patients: A Narrative Review. Implant Dent. 2019 Apr;28(2):161-172. doi: 10.1097/ID.0000000000000837.
• Magnuson B, Harsono M, Stark PC, Lyle D, Kugel G, Perry R. Comparison of the effect of two interdental cleaning devices around implants on the reduction of bleeding: a 30-day randomized clinical trial. Compend Contin Educ Dent. 2013 Nov-Dec;34 Spec No 8:2-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 6, 2019
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (ACTUAL): September 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: dental implants; water flosser
• Other Study ID Numbers: H2019:298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes