PeriodontitisMCOHNCT06887946
Effectiveness of Medical Coaching in Enhancing Periodontal Health and Lifestyle
A study testing Medical couching and traditional in people with Periodontitis, run by University of Bari Aldo Moro at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Medical couching and traditional
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2025to 15 Mar 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Periodontitis Patients
Who cannot join
- Patients who do not wish to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Medical couching and traditional
- Keywords
- Medical Coaching, Periodontitis, Stress, gingival health
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical couching and traditionalOther
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):
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Medical couching and traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Jan 2025
- Primary completion1 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe D'Albis, University of Bari Aldo Moro
- Investigators
- Giuseppe D'Albis Dr, DDS, Principal investigator, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887946
- Sponsor's protocol ID
- Medical Coaching in Perio
- Acronym
- MCOH
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Apr;32(4):1139-1148. doi: 10.1111/odi.70183. Epub 2026 Jan 7.
PubMed 41501894
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Medical Coaching in Enhancing Periodontal Health and Lifestyle: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06887946
- Acronym / sponsor ID
- MCOH / Medical Coaching in Perio
- Conditions
- Periodontitis
- Keywords
- Medical Coaching, Periodontitis, Stress, gingival health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 21 Mar 2025 (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.
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).
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Medical Couching | Experimental | Other: Medical couching and traditionalMCOH 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. |
| control group | Other | Other: Medical couching and traditionalControl 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Periodontitis Patients
Key exclusion criteria (1 listed)
- Patients who do not wish to participate in the study.
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 |
|---|---|---|
| Medical couching and traditionalThe 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 | Medical Couching, control group |
Primary outcome
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.
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
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 25 Mar 2025.
- Derived from this study: PubMed 41501894Antonacci 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 Apr;32(4):1139-1148. doi: 10.1111/odi.70183. Epub 2026 Jan 7.
- 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.
Giuseppe D'Albis Dr, DDS principal investigator
University of Bari Aldo Moro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical couching and traditional in people with Periodontitis, run by University of Bari Aldo Moro at 1 site in Italy.
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 1 inclusion and 1 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 25 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 Italy. 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?
Plaque Control Record (PCR) . (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT06887946, which also lists 1 linked publication.
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 25 Mar 2025.