Efficacy of an Oral Hygiene Implant Protocol

August 25, 2021 updated by: Water Pik, Inc.

Efficacy of an Oral Hygiene Regimen on Implant Supported, Removable Complete Denture: Effect on Gingival Tissue and Prosthesis: A Proof of Concept Study

This study is designed to evaluate the effectiveness of cleaning around implants that hold a full denture in the mouth. Different oral hygiene protocols will be compared. Areas to measure are gum tissue color and consistency, bleeding and cleanliness. A questionnaire will be provided at the end of the study. This is a proof of concept study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The aim of this proof of concept study is to evaluate the effect of an oral hygiene regimen of manual brushing and water flossing on implant retained removable complete dentures. This is a randomized, two arm clinical trial that will compare the traditional oral hygiene regimen to the experimental regimen. Data will be evaluated at baseline, 3 weeks and 6 weeks. Photographs of the tissue and denture will be taken.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts School of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • have a maxillary and/or mandibular implant supported, removable complete denture that is supported by at least 2 implants in good, serviceable condition
  • Good general health, with no diseases which could impact periodontal health
  • able to read and understand English
  • willing to return for all appointments
  • at least 30% BOP
  • probing depths less or equal to 5mm

Exclusion Criteria:

  • subjects who are currently pregnant
  • mobility of implant
  • subjects who have diabetes
  • subjects who smoke
  • subjects with any serious medical condition which the investigator feels may impact participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Manual brushing only
Participants brushed with a manual toothbrush and fluoridated toothpaste twice a day for 6 weeks
Device: Manual Toothbrush
Plastic handle with nylon bristles to clean teeth
Experimental: Manual brushing + water flossing
Participants brush twice a day and water flossed once a day for 6 weeks.
Device: Manual Toothbrush
Plastic handle with nylon bristles to clean teeth
Device: Water Flosser
Device that uses water under pressure to clean around teeth and under the gums

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing
Time Frame: 6 weeks
Binary
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: 6 weeks
mm
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Water Pik, Inc.

Investigators

  • Study Chair: Gerard Kugel, DDS, Tufts School of Dental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

July 2, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29DRIOH2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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