NCT07524504

Brief Summary

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.

Trial Health

63
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
May 2026Dec 2027

First Submitted

Initial submission to the registry

April 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

April 2, 2026

Last Update Submit

April 8, 2026

Conditions

Keywords

PeriodontitisNon-surgical periodontal therapyRe-evaluation

Outcome Measures

Primary Outcomes (1)

  • Percentage of probing pocket depth reduction

    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

Study Arms (1)

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)

Interventions

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.

Non-Surgical Periodontal Therapy Cohort - Plaque Index Evaluation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Odontoiatrica

Chieti, Chieti, 66100, Italy

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Matteo Serroni

    'G. D'annunzio' University of Chieti-Pescara

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Serroni, DDS

CONTACT

Matteo Serroni, DDS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations