Efficacy of an Oral Hygiene Implant Protocol

Not Applicable

Terminated

• Conditions: Peri-implant Mucositis
• Interventions: Device: Water Flosser; Device: Manual Toothbrush

• Registration Number: NCT04462341
• Lead Sponsor: Water Pik, Inc.

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.

Study Timeline

• Study Start: 2019-01-07
• Status Verified: 2020-07
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-08
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual brushing + water flossing	Water Flosser	Participants brush twice a day and water flossed once a day for 6 weeks.
Manual brushing + water flossing	Manual Toothbrush	Participants brush twice a day and water flossed once a day for 6 weeks.
Manual brushing only	Manual Toothbrush	Participants brushed with a manual toothbrush and fluoridated toothpaste twice a day for 6 weeks

Primary Outcome Measures

Name	Time	Method
Bleeding on probing	6 weeks	Binary

Secondary Outcome Measures

Name	Time	Method
Probing depth	6 weeks	mm

Trial Locations

Locations (1)

Tufts School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States