NCT04023500

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Status
unknown

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

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

July 9, 2019

Last Update Submit

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 COMPARATOR

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

Prevailing education

ACTIVE COMPARATOR

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

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.

Motivational interviewPrevailing education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Mirkka Järvinen, MNS

    University of Turku

    PRINCIPAL INVESTIGATOR

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