PeriodontitisNCT05948722
Behavioral Intervention Program Based on Motivational Interview
A study testing Motivational Interview Group (MIG) and Conventional treatment group (CTG) in people with Periodontitis and Periodontal Diseases, run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial summary
The best way for dental professionals act using dialogue methods and individual approaches in daily clinical practice to change behavioral is still inconclusive. Thus, the objective will be evaluate the effect of using motivational interviewing as part of the treatment of periodontitis in order to increase the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Periodontal Diseases, Motivational Interviewing
- What is being tested?
- Motivational Interview Group (MIG) and Conventional treatment group (CTG)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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;
- BoP (Bleeding on probing) in at least 30% of sites;
- Diagnosed periodontitis.
Who cannot join
- Smoking;
- Diabetes;
- Pregnancy (or the planning of pregnancy);
- Immunosuppressive illness or a medication, hepatitis, HIV, a bleeding illness or a anticoagulant;
- A need for the antibiotic prophylaxis;
- Hyposalivation or use of medications that cause hyposalivation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Intervention Program Based on Motivational Interview to Improve Oral Hygiene in Adults - a Randomized Clinical Trial
The best way for dental professionals act using dialogue methods and individual approaches in daily clinical practice to change behavioral is still inconclusive. Thus, the objective will be evaluate the effect of using motivational interviewing as part of the treatment of periodontitis in order to increase the adherence of adults to adequate oral health behavior.
Read the detailed description
Patient-related approaches may show better results in treatment of periodontal diseases. The best way for the dental surgeon to act using these methods is still inconclusive. The aim of this study is to evaluate the effectiveness of using motivational interviewing as part of the treatment of periodontitis in order to increase adult adherence to adequate oral health behavior. A randomized clinical trial, with a sample size of at least 72 subjects, >18 years of age and with at least 18 teeth, will be investigated. Individuals in the test group will receive a collaborative communicative approach, inspired by the motivational interview, while the control group will receive the information/instructions in a conventional approach. The efficacy variables for evaluating the pattern of self-control of periodontal infection will be the bleeding on probing (BoP), gingival index (GI, primary efficacy variable), the plaque index (PI) and patient-based outcomes will be assessed using quality of life questionnaires. Additionally, questionnaires will be applied to obtain sociodemographic, behavioral and self-perception of oral health data. Univariate and multivariate analyzes will be performed and conducted in the Statistical Products Service Solutions software (SPSS, version 25). Thus, it will be possible to assess whether brief oral health education interventions centered on the individual can be used by dental surgeons in order to effectively improve oral hygiene behaviors in adults, obtaining better clinical results and a better quality of life for patients.
- Being tested
- Motivational Interview Group (MIG), Conventional treatment group (CTG)
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interview Group (MIG)Behavioural
Brief MI intervention with the conventional treatment
Conventional treatment group (CTG)Procedure or surgery
Conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview Group (MIG) | Experimental | Participants assigned to this arm will complete three to five MI sessions Receives: Behavioral: Motivational Interview Group (MIG) |
| Conventional treatment group (CTG) | Active comparator | Participants assigned to this arm will receive the conventional treatment Receives: Procedure: Conventional treatment group (CTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Bleeding on Probing to evaluate the improvement in hygiene behavior
BoP - Dichotomic response after probing the gingival sulcus. High values mean worst condition.
Measured: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
The change in Plaque Index to evaluate the improvement in hygiene behavior
PI - Each of the 6 sites of the tooth is given a score from 0 to 3. High values mean worst condition.
Measured: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
The change in Gingival index to evaluate the improvement in hygiene behavior
GI - Each of the 6 sites of the tooth is given a score from 0 to 3. High values mean worst condition.
Measured: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
Patient satisfaction assessed by the change in Quality of Life questionnaire
Quality of life - % of patients with better scores (lowest values) of quality of life. It can vary from 0 to 56.
Measured: baseline, 60 days after subgingival treatment and through study completion, an average of 1 year
Patient perception assessed by the change in autoperception of oral health questionnaire
Autoperception of oral health - rate of patients with better condition of oral health perception. The answer options are: Great; Good; Regular; Bad; Terrible. 0-4 (lower scores mean better self-perception).
Measured: baseline, 60 days after subgingival treatment and through study completion, an average of 1 year
Secondary outcomes (1)
Oral hygiene-related self-efficacy assessed by the oral hygiene-related selfefficacy (OHSE) questionnaire
Oral hygiene-related self-efficacy: % of patients with higher scores of self-efficacy. It ranges from 19 to 76, higher scores mean better self-efficacy.
Measured: 60 days after subgingival treatment and six months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start2 May 2023
- Primary completion1 Sep 2024
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Heitor Cunha Moreira, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948722
- Sponsor's protocol ID
- 059082
- Status last verified
- Mar 2025
- First submitted
- 2 May 2023
- Last updated
- 27 Mar 2025
- 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Intervention Program Based on Motivational Interview to Improve Oral Hygiene in Adults - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05948722
- Acronym / sponsor ID
- 059082
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 17 Jul 2023 (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 best way for dental professionals act using dialogue methods and individual approaches in daily clinical practice to change behavioral is still inconclusive. Thus, the objective will be evaluate the effect of using motivational interviewing as part of the treatment of periodontitis in order to increase the adherence of adults to adequate oral health behavior.
Detailed description
Patient-related approaches may show better results in treatment of periodontal diseases. The best way for the dental surgeon to act using these methods is still inconclusive. The aim of this study is to evaluate the effectiveness of using motivational interviewing as part of the treatment of periodontitis in order to increase adult adherence to adequate oral health behavior. A randomized clinical trial, with a sample size of at least 72 subjects, >18 years of age and with at least 18 teeth, will be investigated. Individuals in the test group will receive a collaborative communicative approach, inspired by the motivational interview, while the control group will receive the information/instructions in a conventional approach. The efficacy variables for evaluating the pattern of self-control of periodontal infection will be the bleeding on probing (BoP), gingival index (GI, primary efficacy variable), the plaque index (PI) and patient-based outcomes will be assessed using quality of life questionnaires. Additionally, questionnaires will be applied to obtain sociodemographic, behavioral and self-perception of oral health data. Univariate and multivariate analyzes will be performed and conducted in the Statistical Products Service Solutions software (SPSS, version 25). Thus, it will be possible to assess whether brief oral health education interventions centered on the individual can be used by dental surgeons in order to effectively improve oral hygiene behaviors in adults, obtaining better clinical results and a better quality of life for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview Group (MIG) | Experimental | Behavioral: Motivational Interview Group (MIG)Participants assigned to this arm will complete three to five MI sessions |
| Conventional treatment group (CTG) | Active comparator | Procedure: Conventional treatment group (CTG)Participants assigned to this arm will receive the conventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults, over 18-year-old;
- BoP (Bleeding on probing) in at least 30% of sites;
- Diagnosed periodontitis.
Key exclusion criteria (6 listed)
- Smoking;
- Diabetes;
- Pregnancy (or the planning of pregnancy);
- Immunosuppressive illness or a medication, hepatitis, HIV, a bleeding illness or a anticoagulant;
- A need for the antibiotic prophylaxis;
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 Group (MIG)Brief MI intervention with the conventional treatment | Behavioural | Motivational Interview Group (MIG) |
| Conventional treatment group (CTG)Conventional treatment | Procedure or surgery | Conventional treatment group (CTG) |
Primary outcome
The change in Bleeding on Probing to evaluate the improvement in hygiene behavior
Time frame: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
BoP - Dichotomic response after probing the gingival sulcus. High values mean worst condition.
The change in Plaque Index to evaluate the improvement in hygiene behavior
Time frame: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
PI - Each of the 6 sites of the tooth is given a score from 0 to 3. High values mean worst condition.
The change in Gingival index to evaluate the improvement in hygiene behavior
Time frame: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
GI - Each of the 6 sites of the tooth is given a score from 0 to 3. High values mean worst condition.
Patient satisfaction assessed by the change in Quality of Life questionnaire
Time frame: baseline, 60 days after subgingival treatment and through study completion, an average of 1 year
Quality of life - % of patients with better scores (lowest values) of quality of life. It can vary from 0 to 56.
Patient perception assessed by the change in autoperception of oral health questionnaire
Time frame: baseline, 60 days after subgingival treatment and through study completion, an average of 1 year
Autoperception of oral health - rate of patients with better condition of oral health perception. The answer options are: Great; Good; Regular; Bad; Terrible. 0-4 (lower scores mean better self-perception).
1 secondary outcome
Oral hygiene-related self-efficacy assessed by the oral hygiene-related selfefficacy (OHSE) questionnaire
Time frame: 60 days after subgingival treatment and six months later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Interview Group (MIG) and Conventional treatment group (CTG) in people with Periodontitis and Periodontal Diseases, run by Universidade Federal de Santa Maria at 1 site in Brazil.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
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?
The change in Bleeding on Probing to evaluate the improvement in hygiene behavior (time frame: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year). The study lists 5 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 27 Mar 2025.