Supporting Oral Self-care of Patients With Periodontitis Through Brief Motivational Interview
Supporting Oral Self-care of Patients With Periodontitis Through Motivational Interview
Sponsors
Source
University of Turku
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
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.
Overall Status
Active, not recruiting
Start Date
2014-05-01
Completion Date
2019-08-30
Primary Completion Date
2015-11-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Bleeding on probing (BoP) |
Up to 6 month |
|
Pocket probing depth (PD) |
Up to 6 month |
|
Clinical Attachment Level (CAL) |
Up to 6 month |
Enrollment
28
Conditions
Intervention
Intervention Type
Behavioral
Intervention Name
Description
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 Group Label
Motivational interview
Prevailing education
Eligibility
Criteria
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.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Mirkka Järvinen, MNS |
Principal Investigator |
University of Turku |
Verification Date
2019-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University of Turku
Investigator Full Name
Mirkka Järvinen
Investigator Title
Principal investigator
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Motivational interview
Arm Group Type
Active Comparator
Description
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.
Arm Group Label
Prevailing education
Arm Group Type
Active Comparator
Description
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.
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)
Masking Description
Double-blinded, patients and dentist who performs baseline and follow-up measurements.
Study First Submitted
July 9, 2019
Study First Submitted Qc
July 16, 2019
Study First Posted
July 17, 2019
Last Update Submitted
July 17, 2019
Last Update Submitted Qc
July 17, 2019
Last Update Posted
July 19, 2019
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.