Efficacy of an Oral Hygiene Implant Protocol

Peri-implant Mucositis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04462341
• Other study ID #: 29DRIOH2019
• Status: Terminated
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2020
• Source: Water Pik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

Device:
• Water Flosser
Device that uses water under pressure to clean around teeth and under the gums
• Manual Toothbrush
Plastic handle with nylon bristles to clean teeth

Locations

Country	Name	City	State
United States	Tufts School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Water Pik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on probing	Binary	6 weeks
Secondary	Probing depth	mm	6 weeks