Effectiveness of Medical Coaching in Enhancing Periodontal Health and Lifestyle (MCOH)

March 20, 2025 updated by: Giuseppe D'Albis, University of Bari Aldo Moro

Effectiveness of Medical Coaching in Enhancing Periodontal Health and Lifestyle: A Pilot Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bari, Italy, 70124
        • Anna Antonacci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Periodontitis Patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medical Couching
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.

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):

Other: control group
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.

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):

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Control Record (PCR) .
Time Frame: 30 days
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)
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Giuseppe D'Albis Dr, DDS, University of Bari Aldo Moro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 15, 2025

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Medical Coaching in Perio

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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