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

Study Overview
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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

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.

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

Conditions
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Implant Site Bleeding

Intervention / Treatment
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* Device: comparing interdental floss to water flosser around dental implants


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled clinical trial in a single center.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: water flosser<br>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<br>* to determine the effectiveness in reducing the bleeding on probing (BOP) index around dental implants<br>|
| Active Comparator: dental floss<br>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<br>* to determine the effectiveness in reducing the bleeding on probing (BOP) index around dental implants<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implants, water flosser