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Active, not recruitingNCT05948722Updated Mar 27, 2025

Behavioral Intervention Program Based on Motivational Interview

An interventional study of Motivational Interview Group (MIG) and Conventional treatment group (CTG) in Periodontitis, Periodontal Diseases and Motivational Interviewing, sponsored by Universidade Federal de Santa Maria. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Universidade Federal de Santa Maria · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 48 studies in Periodontitis with a site in Brazil — 7 open to participants now, 12 under way, 1 of them phase 3. Periodontitis · Brazil.

Planned enrollment
15th of 45
72 · median 56
Started
2023
with 7 others
No phase
27 of 48
5 open now
Primary completion
2024-09
later than 2 of 11 live
Registered
30th of 48
by date
Lead sponsor
2 of 48
Universidade Federal de Santa Maria

Among the 48 studies in Periodontitis with a site in Brazil, this one is the 15th largest by planned enrollment of the 45 interventional ones that give a count, is one of 8 that started in 2023, is one of 27 with no phase, reaches primary completion later than 2 of the 11 other live ones, and was the 30th registered.

Periodontitis

1,232 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

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Open to participants now

7 of the 48 studies in Periodontitis with a site in Brazil are open now. Recruiting first, the newest first:

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All 7 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 158 Periodontitis studies recruiting now, 78 (49%) set no upper age limit and 60 (38%) stop at 75 or younger; 12 take children under 18; 76 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Periodontitis
  • Periodontal Diseases
  • Motivational Interviewing
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults, over 18-year-old;
  • BoP (Bleeding on probing) in at least 30% of sites;
  • Diagnosed periodontitis.

Exclusion criteria

Exclusion Criteria:

  • Smoking;
  • Diabetes;
  • Pregnancy (or the planning of pregnancy);
  • illness or a medication, hepatitis, , a bleeding illness or a anticoagulant;
  • A need for the antibiotic prophylaxis;
  • Hyposalivation or use of medications that cause hyposalivation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Motivational Interview Group (MIG)

    Participants assigned to this arm will complete three to five MI sessions

    Behavioral: Motivational Interview Group (MIG)

  • Active comparator
    Conventional treatment group (CTG)

    Participants assigned to this arm will receive the conventional treatment

    Procedure: Conventional treatment group (CTG)

Interventions

  • BehavioralMotivational Interview Group (MIG)

    Brief MI intervention with the conventional treatment

  • ProcedureConventional treatment group (CTG)

    Conventional treatment

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year

  2. 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.

    Time frame: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year

  3. 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.

    Time frame: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year

  4. 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.

    Time frame: baseline, 60 days after subgingival treatment and through study completion, an average of 1 year

  5. 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).

    Time frame: 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.

    Time frame: 60 days after subgingival treatment and six months later

07

Study locations

1 site
  • Carlos Heitor Moreira
    Santa Maria, RS 97015-900, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in Sep 2024, 15 months.

Of 481 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 15 months is close to that.

Counting every sponsor, half of 495 studies reached it within 15 months; a quarter within 8 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2023
First posted
Jul 17, 2023
StartActual
May 2, 2023
Primary completionActual
Sep 1, 2024
CompletionEst.
Dec 1, 2025
Last update
Mar 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05948722
Lead sponsor
Universidade Federal de Santa Maria
Responsible party
Carlos Heitor Cunha Moreira (Principal Investigator, Universidade Federal de Santa Maria) — Principal investigator
First posted
Jul 17, 2023
Start date
May 2, 2023
Primary completion
Sep 1, 2024
Completion
Dec 1, 2025 (estimated)
Last update
Mar 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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