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Completed

NCT Number: NCT04081311

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

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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Key information

Conditions

Implant Site Bleeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Manitoba

Winnipeg, Manitoba, R3E 0W2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

comparing interdental floss to water flosser around dental implants

Device

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

Primary outcomes

  1. Change in BOP (bleeding on probing) index around dental implants

    Time frame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)

    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

  2. Full Mouth Plaque Score (FMPS)

    Time frame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)

    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

  3. Quigley-Hein plaque index (QHI) around dental implants

    Time frame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)

    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.

  4. keratinized tissue (KT) around dental implants

    Time frame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)

    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.

  5. Probing Depth (PD) around dental implants

    Time frame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)

    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.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2019
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.