- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07524504
Predictive Role of the Full-mouth Plaque Score on the Outcomes of Non-surgical Periodontal Therapy.
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Matteo Serroni, DDS
- Phone Number: +393395824161
- Email: serronimatteo@gmail.com
Study Contact Backup
- Name: Matteo Serroni, DDS
Study Locations
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-
Chieti
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Chieti, Chieti, Italy, 66100
- Clinica Odontoiatrica
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Contact:
- Matteo Serroni, DDS
- Phone Number: +393395824161
- Email: serronimatteo@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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
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).
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Baseline, 3, 6 9 and 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matteo Serroni, 'G. D'annunzio' University of Chieti-Pescara
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02042026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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