NCT06887946

Brief Summary

Periodontitis is a chronic inflammatory disease that adversely influences the supporting tissues of the teeth. It is primarily characterized by the accumulation of bacterial plaque and the host immune response. Traditional periodontal therapy emphasizes the central roles of both oral hygiene education and risk factor management; however, maintaining a long-term optimal behavioral compliance remains challenging. The purpose of this Randomized Controlled Trial is to assess how effective is Medical Coaching on Oral Health (MCOH) in improving plaque control (PCR) and gingival health (GBI) in patients with periodontitis after one month, in comparison to traditional oral hygiene instructions (OHI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 19, 2025

Last Update Submit

March 20, 2025

Conditions

Keywords

Medical CoachingPeriodontitisStressgingival health

Outcome Measures

Primary Outcomes (2)

  • Plaque Control Record (PCR) .

    The percentage value was calculated as follows: Number of surfaces with plaque / Total number of surfaces examined × 100. The lower the percentage, the better the plaque control; the higher the percentage, the worse the oral hygiene.

    30 days

  • Gingival Bleeding Index (GBI)

    The calculation to the GBI was as follows: number of bleeding sites/number of evaluated sites ×100. obtain the percentage value was as follows: number of bleeding sites/number of evaluated sites ×100

    30 days

Study Arms (2)

Medical Couching

EXPERIMENTAL

MCOH group (n=32) . The baseline assessments included periodontal status, PCR, GBI (describe the achronym) and a systematic questionnaire on lifestyle factors (smoking, alcohol, food, exercise, sleep, and stress). The intervention group received tailored MCOH sessions that comprised goal-setting, emotional hurdle assessment and action planning, whereas the control group received conventional OHI.

Other: Medical couching and traditional

control group

OTHER

Control group (n=32.)Control group received traditional OHI using the tell-show-do method, which was personalized based on the individual PCR and GBI. The recommendations were tailored to each participant, based on personalized instructions to improve plaque control, decrease of gingival inflammation and facilitate optimal patient compliance, contributing to oral hygiene performance.

Other: Medical couching and traditional

Interventions

The control group received traditional OHI using the tell-show-do method, which was personalized based on the individual PCR and GBI. The recommendations were tailored to each participant, based on personalized instructions to improve plaque control, decrease of gingival inflammation and facilitate optimal patient compliance, contributing to oral hygiene performance. The intervention group was actively engaged in an iterative, collaborative process, based on the following steps: Definition of the goals of oral hygiene and lifestyle styles according to the SMART model (Specific, Measurable, Achievable, Realistic, Timely):

Medical Couchingcontrol group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Periodontitis Patients

You may not qualify if:

  • Patients who do not wish to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anna Antonacci

Bari, 70124, Italy

Location

Related Publications (1)

  • Antonacci A, D'Albis G, Bartolomeo N, Agneta MT, Abbinante A, Marini L, Pilloni A, Capodiferro S. Effectiveness of Medical Coaching in Enhancing Periodontal Health and Lifestyle: A Clinical Trial. Oral Dis. 2026 Jan 7. doi: 10.1111/odi.70183. Online ahead of print.

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Giuseppe D'Albis Dr, DDS

    University of Bari Aldo Moro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 21, 2025

Study Start

January 1, 2025

Primary Completion

March 1, 2025

Study Completion

March 15, 2025

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations