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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04023500
Other study ID # University of Turku
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2014
Est. completion date August 30, 2019

Study information

Verified date July 2019
Source University of Turku
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date August 30, 2019
Est. primary completion date November 1, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Turku

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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