Back to resultsEfficacy of an Oral Hygiene Implant Protocol
Primary Purpose
Peri-implant Mucositis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water Flosser
Manual Toothbrush
Sponsored by
About this trial
This is an interventional supportive care trial for Peri-implant Mucositis
Eligibility Criteria
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
Sites / Locations
- Tufts School of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Manual brushing only
Manual brushing + water flossing
Arm Description
Participants brushed with a manual toothbrush and fluoridated toothpaste twice a day for 6 weeks
Participants brush twice a day and water flossed once a day for 6 weeks.
Outcomes
Primary Outcome Measures
Bleeding on probing
Binary
Secondary Outcome Measures
Probing depth
mm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04462341
Brief Title
Efficacy of an Oral Hygiene Implant Protocol
Official Title
Efficacy of an Oral Hygiene Regimen on Implant Supported, Removable Complete Denture: Effect on Gingival Tissue and Prosthesis: A Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Water Pik, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual brushing only
Arm Type
Active Comparator
Arm Description
Participants brushed with a manual toothbrush and fluoridated toothpaste twice a day for 6 weeks
Arm Title
Manual brushing + water flossing
Arm Type
Experimental
Arm Description
Participants brush twice a day and water flossed once a day for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Water Flosser
Intervention Description
Device that uses water under pressure to clean around teeth and under the gums
Intervention Type
Device
Intervention Name(s)
Manual Toothbrush
Intervention Description
Plastic handle with nylon bristles to clean teeth
Primary Outcome Measure Information:
Title
Bleeding on probing
Description
Binary
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Probing depth
Description
mm
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Kugel, DDS
Organizational Affiliation
Tufts School of Dental Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Tufts School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of an Oral Hygiene Implant Protocol
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