Clinical trial NCT04081311: A Comparison of the Efficacy of Interdental Floss to Water Flosser Around Dental Implants
Official title: A Comparison of the Efficacy of Interdental Floss to Water Flosser Around Dental Implants in Maintenance Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Site Bleeding
Keywords: dental implants
water flosser
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled clinical trial in a single center.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in BOP (bleeding on probing) index around dental implants
timeFrame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
measure: Full Mouth Plaque Score (FMPS)
timeFrame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
measure: Quigley-Hein plaque index (QHI) around dental implants
timeFrame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
measure: keratinized tissue (KT) around dental implants
timeFrame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
measure: Probing Depth (PD) around dental implants
timeFrame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.