Oral HygieneMIOrthoNCT02829567
Motivational Interviewing in Orthodontic Patients
A study testing Motivational interviewing in people with Oral Hygiene, run by University of Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether motivational interviewing is effective in improving oral hygiene in orthodontic patients wearing fixed appliances. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Motivational interviewing
- 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
- 130 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Apr 2018
- 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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Orthodontic patients wearing fixed appliances, within the first six months of treatment
- Eruption completed (except for the third molars) or late mixed dentition.
- Caucasian
Who cannot join
- Pregnancy
- Periodontal disease
- Systemic illness
- Medical treatment
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Odontològic Universitat de Barcelona
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Effectiveness of Motivational Interviewing in Improving Oral Hygiene in Orthodontic Patients
The purpose of this study is to determine whether motivational interviewing is effective in improving oral hygiene in orthodontic patients wearing fixed appliances.
- Conditions
- Oral Hygiene
- Being tested
- Motivational interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Oral hygiene counseling and motivational interviewing | Experimental | This group will receive a session of oral hygiene counseling and a single session of motivational interviewing to increase the readiness of change. Receives: Behavioral: Motivational interviewing |
| Oral hygiene counseling | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess change in oral hygiene using plaque index Löe & Silness
Plaque index Löe \& Silness (Time: baseline, 1 month and 6 months)
Measured: Baseline, 1 month and 6 months
Secondary outcomes (1)
Assess change in oral hygiene using gingival index Löe & Silness
Gingival index Löe \& Silness ( Time: baseline, 1 month and 6 months)
Measured: Baseline, 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral HygieneStudies 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Montserrat Rigau Gay, University of Barcelona
- Investigators
- Maria Montserrat Rigau Gay, DDS, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829567
- Sponsor's protocol ID
- MI01
- Acronym
- MIOrtho
- Status last verified
- Apr 2018
- First submitted
- 26 Jun 2016
- Last updated
- 2 May 2018
- Results posted
- No
Publications
Martins RK, McNeil DW. Review of Motivational Interviewing in promoting health behaviors. Clin Psychol Rev. 2009 Jun;29(4):283-93. doi: 10.1016/j.cpr.2009.02.001. Epub 2009 Feb 23.
PubMed 19328605Rigau-Gay MM, Claver-Garrido E, Benet M, Lusilla-Palacios P, Ustrell-Torrent JM. Effectiveness of motivational interviewing to improve oral hygiene in orthodontic patients: A randomized controlled trial. J Health Psychol. 2020 Nov-Dec;25(13-14):2362-2373. doi: 10.1177/1359105318793719. Epub 2018 Sep 10.
PubMed 30198774
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Motivational Interviewing in Improving Oral Hygiene in Orthodontic Patients
- ClinicalTrials.gov ID
- NCT02829567
- Acronym / sponsor ID
- MIOrtho / MI01
- Conditions
- Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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 purpose of this study is to determine whether motivational interviewing is effective in improving oral hygiene in orthodontic patients wearing fixed appliances.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral hygiene counseling and motivational interviewing | Experimental | Behavioral: Motivational interviewingThis group will receive a session of oral hygiene counseling and a single session of motivational interviewing to increase the readiness of change. |
| Oral hygiene counseling | No intervention | – |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Orthodontic patients wearing fixed appliances, within the first six months of treatment
- Eruption completed (except for the third molars) or late mixed dentition.
- Caucasian
Key exclusion criteria (4 listed)
- Pregnancy
- Periodontal disease
- Systemic illness
- Medical treatment
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 interviewing | Behavioural | Oral hygiene counseling and motivational interviewing |
Primary outcome
Assess change in oral hygiene using plaque index Löe & Silness
Time frame: Baseline, 1 month and 6 months
Plaque index Löe \& Silness (Time: baseline, 1 month and 6 months)
1 secondary outcome
Assess change in oral hygiene using gingival index Löe & Silness
Time frame: Baseline, 1 month and 6 months
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 2 May 2018.
- Background: PubMed 19328605Martins RK, McNeil DW. Review of Motivational Interviewing in promoting health behaviors. Clin Psychol Rev. 2009 Jun;29(4):283-93. doi: 10.1016/j.cpr.2009.02.001. Epub 2009 Feb 23.
- Derived from this study: PubMed 30198774Rigau-Gay MM, Claver-Garrido E, Benet M, Lusilla-Palacios P, Ustrell-Torrent JM. Effectiveness of motivational interviewing to improve oral hygiene in orthodontic patients: A randomized controlled trial. J Health Psychol. 2020 Nov-Dec;25(13-14):2362-2373. doi: 10.1177/1359105318793719. Epub 2018 Sep 10.
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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.
Maria Montserrat Rigau Gay, DDS principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Oral Hygiene, run by University of Barcelona at 1 site in Spain.
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 3 inclusion and 4 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 2 May 2018. 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 Spain. 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?
Assess change in oral hygiene using plaque index Löe & Silness (time frame: Baseline, 1 month and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02829567, which also lists 2 linked publications.
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 2 May 2018.