Predictive Role of the Full-mouth Plaque Score on the Outcomes of Non-surgical Periodontal Therapy.

April 8, 2026 updated by: Matteo Serroni, G. d'Annunzio University

Predictive Role of Full-Mouth Plaque Score on the Outcomes of Non-Surgical Periodontal Therapy: A Prospective Cohort Study

Oral hygiene quality is a key determinant of outcomes in both non-surgical and surgical periodontal therapy. Previous studies have demonstrated the negative impact of site-specific plaque accumulation on periodontal parameters. However, to the best of our knowledge, no studies have specifically investigated the correlation between plaque index and the percentage reduction in periodontal pocket depth, nor its association with other periodontal clinical parameters.

The aim of this study is to evaluate the relationship between plaque index and the percentage reduction in periodontal pockets, as well as its association with key periodontal parameters.

Following baseline data collection, patients will undergo non-surgical periodontal therapy in accordance with current guidelines. Clinical outcomes will be reassessed at 3, 6, 9, and 12 months post-treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Matteo Serroni, DDS

Study Locations

  • Italy
    • Chieti
      • Chieti, Chieti, Italy, 66100

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

At least 100 patients with a baseline diagnosis of periodontitis, aged between 18 and 80 years, who have never received periodontal treatment, will be included in the study. Patients will be recruited from the Unit of Periodontology and Dental Hygiene at the Dental Clinic of the Department of Innovative Technologies in Medicine and Dentistry, University of "Gabriele D'Annunzio" of Chieti. Periodontitis will be diagnosed according to the criteria of Tonetti et al., 2018, regardless of grade, stage, or extent of the disease, in cases where periodontal diagnosis and treatment are indicated.

Patients must have a confirmed diagnosis of periodontitis and be within the age range of 18 to 80 years. Individuals who have previously received periodontal treatment, are currently taking antibiotics or have taken antibiotics in the past three months, are pregnant or breastfeeding, or have systemic diseases or are on medications that contraindicate periodontal treatment or could influence study outc

Description

Inclusion Criteria:

  • Diagnosis of periodontitis according to current guidelines.
  • Age between 18 and 80 years.

Exclusion Criteria:

  • Patients who have previously received periodontal treatment.
  • Patients currently on antibiotic therapy or who have taken antibiotics in the past 3 months.
  • Pregnant or breastfeeding women.
  • Presence of systemic diseases or use of medications in which periodontal treatment is contraindicated or could affect study outcomes (e.g., antihypertensives, antiepileptics, immunosuppressants).

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Non-Surgical Periodontal Therapy Cohort - Plaque Index Evaluation
This cohort includes patients diagnosed with periodontitis who will undergo non-surgical periodontal therapy according to current guidelines. Baseline full mouth plaque index (FMPS) and other periodontal parameters will be recorded. FMPS will be collected at each follow-up visit. Clinical outcomes, including pocket depth reduction and other periodontal measures, will be assessed at 3, 6, 9, and 12 months post-treatment to evaluate the association between oral hygiene and treatment response.
Procedure: Non-surgical periodontal therapy (NSPT)
Patients will receive non-surgical periodontal therapy, including professional supragingival (Step 1) and subgingival scaling and root planing (Step 2), according to current guidelines (Herrera et al., 2023). Oral hygiene instructions will be provided at baseline and reinforced at each follow-up visit. Clinical outcomes, including percentage of pocket depth reduction and plaque index (FMPS), will be recorded at 3, 6, 9, and 12 months post-treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of probing pocket depth reduction
Time Frame: Baseline, 3, 6 9 and 12 months
The primary outcome is the percentage reduction in probing pocket depth (PPD) at treated sites compared to baseline. PPD will be measured using a calibrated periodontal probe at each follow-up visit (3, 6, 9, and 12 months).
Baseline, 3, 6 9 and 12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
G. d'Annunzio University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matteo Serroni, 'G. D'annunzio' University of Chieti-Pescara

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 02042026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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