NCT04462341

Efficacy of an Oral Hygiene Implant Protocol

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Water Pik, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peri-implant Mucositis

Interventions

Type	Name	Description
DEVICE	Water Flosser	Device that uses water under pressure to clean around teeth and under the gums
DEVICE	Manual Toothbrush	Plastic handle with nylon bristles to clean teeth

Timeline

• Start date: 2019-01-07
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-07-08
• Last updated: 2021-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study