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

Primary Purpose

Periodontal Diseases, Patient Education, Self-Care

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational interview vs. prevailing education
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Motivational interview

    Prevailing education

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 9, 2019
    Last Updated
    July 17, 2019
    Sponsor
    University of Turku
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04023500
    Brief Title
    Supporting Oral Self-care of Patients With Periodontitis Through Motivational Interview
    Official Title
    Supporting Oral Self-care of Patients With Periodontitis Through Brief Motivational Interview
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2014 (Actual)
    Primary Completion Date
    November 1, 2015 (Actual)
    Study Completion Date
    August 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Turku

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Diseases, Patient Education, Self-Care

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    Double-blinded, patients and dentist who performs baseline and follow-up measurements.
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Motivational interview
    Arm Type
    Active Comparator
    Arm 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 Title
    Prevailing education
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational interview vs. prevailing education
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Bleeding on probing (BoP)
    Description
    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.
    Time Frame
    Up to 6 month
    Title
    Pocket probing depth (PD)
    Description
    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.
    Time Frame
    Up to 6 month
    Title
    Clinical Attachment Level (CAL)
    Description
    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.
    Time Frame
    Up to 6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mirkka Järvinen, MNS
    Organizational Affiliation
    University of Turku
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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