Efficacy of an Oral Hygiene Implant Protocol

Water Pik

Status: Terminated

Conditions: Peri-implant Mucositis

Treatments: Device: Manual Toothbrush; Device: Water Flosser

Study type: Interventional

Funder types: Industry

Identifiers

NCT04462341

29DRIOH2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6 participants in 2 patient groups

Manual brushing only

Active Comparator group

Description:

Participants brushed with a manual toothbrush and fluoridated toothpaste twice a day for 6 weeks

Treatment:

Device: Manual Toothbrush

Manual brushing + water flossing

Experimental group

Description:

Participants brush twice a day and water flossed once a day for 6 weeks.

Treatment:

Device: Manual Toothbrush

Device: Water Flosser