Viewing Study NCT03298620


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Study NCT ID: NCT03298620
Status: COMPLETED
Last Update Posted: 2017-10-02
First Post: 2017-09-26
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Electric and Manual Toothbrushes in Nursing Homes
Sponsor: University of Oslo
Organization:

Study Overview

Official Title: Effect of Electric Toothbrush on Oral Hygiene in Nursing Home Residents- a Randomized Clinical Trial
Status: COMPLETED
Status Verified Date: 2017-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Effect of electric toothbrush on oral hygiene in nursing home residents tested I randomized clinical trial for 2 months and followed up 12 months after baseline
Detailed Description: Patients in nursing homes often have many natural teeth with exposed root surfaces, bifurcations, a complexity of dental restorations like partial prostheses, bridges/crowns, fillings and implants. In addition they have a limited physical ability, like reduced muscular strength, rigidness in the neck and spine. All these factors contribute to make it difficult, both for themselves and their nursing staff to maintain good oral hygiene.

Electrical toothbrushes have been proved effective in removal of dental plaque. There have also been reports from nursing homes that approves of electrical toothbrushes as a helpful aid among the nursing staff.

The present study examine if the overall oral hygiene actually improves with the use of electric toothbrush.

Material and method: The study is a randomized clinical trial (RCT) that includes patients from nursing homes in Oslo. The recording dentist is blind to the type of tooth brush Inclusion criteria.

* Patients living in nursing home in Oslo
* Provide written informed consent prior to enrolment (from relatives when patients were assessed by physician to be without ability to give written consent.

Participants in the experimental group use an electrical toothbrush. Participants in the control group use a standard manual toothbrush.

Registration of oral hygiene and plaque score at baseline 0 and after 2 months intervention.

After the RCT trial the participants were free to choose toothbrush, electric or manual. The study includes a follow-up study 10 months after the end of the RCT trial.

The study is a part of the PhD programme for Katrine Gahre Fjeld Cand. Odont.

Supervisors:

Tiril Willumsen Dr Odont, The Dental Faculty, University of Oslo Hilde Eide Dr. Philos, Department of Nursing, Buskerud University College Morten Mowe Dr med, The Medical Faculty, University of Oslo

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: