Supporting Oral Self-care of Patients With Periodontitis Through Motivational Interview

Sponsor

University of Turku (Other)

Overall Status

Unknown status

CT.gov ID

NCT04023500

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study was to evaluate the potential additive effect of Motivational Interviewing (MI) on gingival health and self-care. Our hypothesis was that the Motivational Interviewing would result in improved gingival health and self-care compared to prevailing patient education.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases Patient Education Self-Care	Behavioral: Motivational interview vs. prevailing education	N/A

Detailed Description

The study is designed as a randomized, double-blinded, controlled clinical trial of 6-month duration involving patients with diagnosed periodontitis. The subjects are randomized to intervention or control group using the randomizing list.

For both groups, necessary non-surgical periodontal treatments will be done. In the intervention group The MI-intervention is used as a part of normal dental hygienist appointment and if patient need more than one visit, MI was used in every visit.

In control group prevailing, more professional-centered education is used. Dental hygienist define patients educational needs and give direct instructions how to change behaviour and self-care.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double-blinded, patients and dentist who performs baseline and follow-up measurements.

Primary Purpose:

Prevention

Official Title:

Supporting Oral Self-care of Patients With Periodontitis Through Brief Motivational Interview

Actual Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Aug 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Motivational interview The MI-intervention is used as a part of normal dental hygienist appointment. Dental hygienists are trained to focus on patients view of their oral health, self-care skills and need for oral-health related behaviour change. They are supposed to use open-ended questions, reflective listening and reinforcing with patients. Dental hygienist support patients in decision making although patients were addressed as an active agent.	Behavioral: Motivational interview vs. prevailing education In intervention group dental hygienists are trained to focus on patients view of their oral health, self-care skills and need for oral-health related behaviour change. They are supposed to use open-ended questions, reflective listening and reinforcing with patients. In control croup dental hygienist defined patients educational needs and gave direct instructions how to change behaviour and self-care.
Active Comparator: Prevailing education In control group prevailing, more professional-centered education is used. Dental hygienist define patients educational needs and give direct instructions how to change behaviour and self-care.	Behavioral: Motivational interview vs. prevailing education In intervention group dental hygienists are trained to focus on patients view of their oral health, self-care skills and need for oral-health related behaviour change. They are supposed to use open-ended questions, reflective listening and reinforcing with patients. In control croup dental hygienist defined patients educational needs and gave direct instructions how to change behaviour and self-care.

Arm

Intervention/Treatment

Active Comparator: Motivational interview

The MI-intervention is used as a part of normal dental hygienist appointment. Dental hygienists are trained to focus on patients view of their oral health, self-care skills and need for oral-health related behaviour change. They are supposed to use open-ended questions, reflective listening and reinforcing with patients. Dental hygienist support patients in decision making although patients were addressed as an active agent.

Behavioral: Motivational interview vs. prevailing education

In intervention group dental hygienists are trained to focus on patients view of their oral health, self-care skills and need for oral-health related behaviour change. They are supposed to use open-ended questions, reflective listening and reinforcing with patients. In control croup dental hygienist defined patients educational needs and gave direct instructions how to change behaviour and self-care.

Active Comparator: Prevailing education

In control group prevailing, more professional-centered education is used. Dental hygienist define patients educational needs and give direct instructions how to change behaviour and self-care.

Behavioral: Motivational interview vs. prevailing education

Outcome Measures

Primary Outcome Measures

Bleeding on probing (BoP) [Up to 6 month]
Change in BoP is measured three times during the study. In the baseline and in the tree- and six-months follow-up. Bop is recorded60 seconds after the pocket probing and assessed as present (1) or absent (0) on four surfaces.
Pocket probing depth (PD) [Up to 6 month]
Change in PD is measured three times during the study. In the baseline and in the tree- and six-months follow-up. PD is measured at mesial, distal, lingual and buccal surfaces.
Clinical Attachment Level (CAL) [Up to 6 month]
Change in CAL is measured three times during the study. In the baseline and in the tree- and six-months follow-up. CAL is measured if cemento-enamel junction is uncovered or if there is 6 mm deep or deeper gingival pocket.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults, over 18-year-old
CPI (Community periodontal index) 3 in at least two sextants and
Diagnosed parodontitis
The previous treatment period should have been more than one year ago.

Exclusion Criteria:

pregnancy (or the planning of pregnancy)
immunosuppressive illness or a medication,
hepatitis, HIV, MRSA (methicillin-resistant Staphylococcus aureus)
a bleeding illness or a anticoagulant (excluding primalan 100-200 mg / a day)
the labile diabetes
cytotoxic treatment
a need for the antibiotic prophylaxis.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Turku

Investigators

Principal Investigator: Mirkka Järvinen, MNS, University of Turku

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mirkka Järvinen, Principal investigator, University of Turku

ClinicalTrials.gov Identifier:

NCT04023500

Other Study ID Numbers:

University of Turku

First Posted:

Jul 17, 2019

Last Update Posted:

Jul 19, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Periodontal Diseases

Study Results

No Results Posted as of Jul 19, 2019