- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04462341
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
-
-
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
|
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.
|
Plastic handle with nylon bristles to clean teeth
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
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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