Supporting Oral Self-care of Patients With Periodontitis Through Motivational Interview
1 other identifier
interventional
28
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedJuly 19, 2019
July 1, 2019
1.5 years
July 9, 2019
July 17, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Bleeding on probing (BoP)
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.
Up to 6 month
Pocket probing depth (PD)
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.
Up to 6 month
Clinical Attachment Level (CAL)
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.
Up to 6 month
Study Arms (2)
Motivational interview
ACTIVE COMPARATORThe 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.
Prevailing education
ACTIVE COMPARATORIn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mirkka Järvinen, MNS
University of Turku
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blinded, patients and dentist who performs baseline and follow-up measurements.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 9, 2019
First Posted
July 17, 2019
Study Start
May 1, 2014
Primary Completion
November 1, 2015
Study Completion
August 30, 2019
Last Updated
July 19, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share