Efficacy of an Oral Hygiene Implant Protocol

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peri-implant Mucositis

Intervention / Treatment
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* Device: Water Flosser
* Device: Manual Toothbrush


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing | Binary | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | mm | 6 weeks |