Periodontal DiseasesNCT04023500
Supporting Oral Self-care of Patients With Periodontitis Through Motivational Interview
A study testing Motivational interview vs. prevailing education in people with Periodontal Diseases and Patient Education, run by University of Turku.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Diseases, Patient Education, Self-Care
- What is being tested?
- Motivational interview vs. prevailing education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Supporting Oral Self-care of Patients With Periodontitis Through Brief Motivational Interview
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.
Read the 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.
- Conditions
- Periodontal Diseases, Patient Education, Self-Care
- Being tested
- Motivational interview vs. prevailing education
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interview vs. prevailing educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Motivational interview vs. prevailing education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 May 2014
- Primary completion1 Nov 2015
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirkka Järvinen, University of Turku
- Investigators
- Mirkka Järvinen, MNS, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023500
- Sponsor's protocol ID
- University of Turku
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Oral Self-care of Patients With Periodontitis Through Brief Motivational Interview
- ClinicalTrials.gov ID
- NCT04023500
- Acronym / sponsor ID
- University of Turku
- Conditions
- Periodontal Diseases, Patient Education, Self-Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interview | Active comparator | Behavioral: Motivational interview vs. prevailing educationThe 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 comparator | Behavioral: Motivational interview vs. prevailing educationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interview vs. prevailing educationIn 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. | Behavioural | Motivational interview, Prevailing education |
Primary outcome
Bleeding on probing (BoP)
Time frame: Up to 6 month
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)
Time frame: Up to 6 month
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)
Time frame: Up to 6 month
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirkka Järvinen, MNS principal investigator
University of Turku
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview vs. prevailing education in people with Periodontal Diseases and Patient Education, run by University of Turku.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on probing (BoP) (time frame: Up to 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.