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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04462341

Enrollment

Registered

2020-07-08

Start date

2019-01-07

Completion date

2021-06-01

Last updated

2021-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implant Mucositis

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.

Interventions

DEVICEWater Flosser

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

DEVICEManual Toothbrush

Plastic handle with nylon bristles to clean teeth

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Bleeding on probing	6 weeks	Binary

Secondary

Measure	Time frame	Description
Probing depth	6 weeks	mm

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026