Efficacy of an Oral Hygiene Implant Protocol

NCT ID: NCT04462341

Last Updated: 2021-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2021-06-01

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.

Conditions

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Peri-implant Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Manual brushing only

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

Group Type ACTIVE_COMPARATOR

Manual Toothbrush

Intervention Type DEVICE

Plastic handle with nylon bristles to clean teeth

Manual brushing + water flossing

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

Group Type EXPERIMENTAL

Water Flosser

Intervention Type DEVICE

Device that uses water under pressure to clean around teeth and under the gums

Manual Toothbrush

Intervention Type DEVICE

Plastic handle with nylon bristles to clean teeth

Interventions

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Water Flosser

Device that uses water under pressure to clean around teeth and under the gums

Intervention Type DEVICE

Manual Toothbrush

Plastic handle with nylon bristles to clean teeth

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Water Pik, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerard Kugel, DDS

Role: STUDY_CHAIR

Tufts School of Dental Medicine

Locations

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Tufts School of Dental Medicine

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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29DRIOH2019

Identifier Type: -

Identifier Source: org_study_id

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