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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-06

Study Completion Date

2021-03-31

Brief Summary

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

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Detailed Description

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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

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Implant Site Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled clinical trial in a single center.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

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

Study Groups

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water flosser

patient will be provided with Waterpik Water Flosser and instructed to water floss around the implant once a day, preferably at nighttime

Group Type EXPERIMENTAL

comparing interdental floss to water flosser around dental implants

Intervention Type DEVICE

to determine the effectiveness in reducing the bleeding on probing (BOP) index around dental implants

dental floss

patient will be instructed to floss with TePe Bridge and Implant Floss once a day, preferably at nighttime

Group Type ACTIVE_COMPARATOR

comparing interdental floss to water flosser around dental implants

Intervention Type DEVICE

to determine the effectiveness in reducing the bleeding on probing (BOP) index around dental implants

Interventions

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comparing interdental floss to water flosser around dental implants

to determine the effectiveness in reducing the bleeding on probing (BOP) index around dental implants

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes