Motivational Interviewing, BMI, OHINCT03571958
Brief Motivational Interviewing (BMI)
A study testing BMI in people with Motivational Interviewing, BMI, OHI, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of this research study is to determine if the utilization of brief motivational interviewing (BMI) during continuous care is superior compared to traditional oral hygiene instruction (OHI) to reduce patients' plaque score, bleeding on probing (BOP), and gingival index (GI) longitudinal. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motivational Interviewing, BMI, OHI
- What is being tested?
- BMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Oct 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- ≥ 18 years old
- Periodontal maintenance phase (at least one year)
- Plaque score ≥30% (O'Leary plaque score)
- Minimum of two sites with BOP
- Willingness to fulfill all study requirements
- Patient of Record at the University of Minnesota School of Dentistry
Who cannot join
- Current smoker or quit smoking less than one year
- Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)
- Uncontrolled diabetes (HbA1C > 7)
- Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections, cancer, and/or HIV/AIDS)
- Current use of oral bisphosphonates
- History of IV bisphosphonates
Show all 9Show fewer
- Require pre-medication or on long-term antibiotics
- Current orthodontic treatment or planning to begin orthodontic treatment during the study
- Unable to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Brief Motivational Interviewing During Continuous Patient Care to Enhance Oral Hygiene
The goal of this research study is to determine if the utilization of brief motivational interviewing (BMI) during continuous care is superior compared to traditional oral hygiene instruction (OHI) to reduce patients' plaque score, bleeding on probing (BOP), and gingival index (GI) longitudinal. An additional goal is to investigate chairside time of implementing BMI.
- Conditions
- Motivational Interviewing, BMI, OHI
- Being tested
- BMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMIBehavioural
A derivative of motivational interviewing (MI), which is a patient-centered, collaborative counseling approach to strengthen an individual's intrinsic motivation towards a positive behavior change. BMI is intended for healthcare providers with limited time (5-10 minutes) to support a positive behavior change.
| Study group | Role | What they receive |
|---|---|---|
| Traditional OHI (Control) | No intervention | Advice giving method of OHI known as "tell-show-do" to inform, demonstrate, and expect patient compliance. |
| BMI (Test) | Experimental | A derivative of motivational interviewing (MI), which is a patient-centered, collaborative counseling approach to strengthen an individual's intrinsic motivation towards a positive behavior change. BMI is intended for healthcare providers with limited time (5-10 minutes) to support a positive behavior change. Receives: Behavioral: BMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque score
Excellent hygiene: 0-20%, Good hygiene: 21-40%, Fair hygiene: 41-60%, Poor hygiene: 61-100%
Measured: Recorded four times over a one year time frame
Bleeding on probing (BOP)
Presence of bleeding (yes) or absent of bleeding (no)
Measured: Recorded four times over a one year time frame
Gingival Index
0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding)
Measured: Recorded four times over a one year time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start1 Oct 2018
- Primary completion18 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motivational Interviewing, BMI, OHIStudies 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
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Arnett, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571958
- Sponsor's protocol ID
- DENT-2018-26921
- Status last verified
- Apr 2022
- First submitted
- 18 Jun 2018
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Brief Motivational Interviewing During Continuous Patient Care to Enhance Oral Hygiene
- ClinicalTrials.gov ID
- NCT03571958
- Acronym / sponsor ID
- DENT-2018-26921
- Conditions
- Motivational Interviewing, BMI, OHI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 28 Jun 2018 (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 goal of this research study is to determine if the utilization of brief motivational interviewing (BMI) during continuous care is superior compared to traditional oral hygiene instruction (OHI) to reduce patients' plaque score, bleeding on probing (BOP), and gingival index (GI) longitudinal. An additional goal is to investigate chairside time of implementing BMI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional OHI (Control) | No intervention | –Advice giving method of OHI known as "tell-show-do" to inform, demonstrate, and expect patient compliance. |
| BMI (Test) | Experimental | Behavioral: BMIA derivative of motivational interviewing (MI), which is a patient-centered, collaborative counseling approach to strengthen an individual's intrinsic motivation towards a positive behavior change. BMI is intended for healthcare providers with limited time (5-10 minutes) to support a positive behavior change. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female
- ≥ 18 years old
- Periodontal maintenance phase (at least one year)
- Plaque score ≥30% (O'Leary plaque score)
- Minimum of two sites with BOP
Key exclusion criteria (9 listed)
- Current smoker or quit smoking less than one year
- Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)
- Uncontrolled diabetes (HbA1C > 7)
- Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections, cancer, and/or HIV/AIDS)
- Current use of oral bisphosphonates
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 |
|---|---|---|
| BMIA derivative of motivational interviewing (MI), which is a patient-centered, collaborative counseling approach to strengthen an individual's intrinsic motivation towards a positive behavior change. BMI is intended for healthcare providers with limited time (5-10 minutes) to support a positive behavior change. | Behavioural | BMI (Test) |
Primary outcome
Plaque score
Time frame: Recorded four times over a one year time frame
Excellent hygiene: 0-20%, Good hygiene: 21-40%, Fair hygiene: 41-60%, Poor hygiene: 61-100%
Bleeding on probing (BOP)
Time frame: Recorded four times over a one year time frame
Presence of bleeding (yes) or absent of bleeding (no)
Gingival Index
Time frame: Recorded four times over a one year time frame
0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: Undecided
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.
Michelle Arnett, MS principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMI in people with Motivational Interviewing, BMI, OHI, run by University of Minnesota at 1 site in United States.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plaque score (time frame: Recorded four times over a one year time frame). 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 21 Apr 2022.