Granulation Tissue From Residual Periodontal Pockets (GTRP)

Histological Analysis of Granulation Tissue From Residual Periodontal Pockets

This observational study aims to describe the histopathological features of granulation tissue (GT) found in residual periodontal pockets at the time of surgical intervention, after completion of the first two steps of periodontal therapy, according to EFP guidelines (Sanz et al., 2020).

A secondary objective was to analyze GT characteristics in relation to clinical outcomes (e.g., defect type, probing depth reduction and clinical attachment gain) in order to identify possible statistical associations between tissue patterns and clinical improvements.

Study Overview

• Status: Enrolling by invitation
• Conditions: Periodontitis

Detailed Description

The study was conducted at the Section of Periodontology, Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Italy.

Ethical approval was obtained from the Sapienza University Ethics Committee (6997 / 23-01-2023).

Granulation tissue samples were collected during standard periodontal surgery from tissues that would normally be removed, without any additional intervention for the enrolled patients.

• Study Type: Observational
• Enrollment (Estimated): 21

Contacts and Locations

Study Locations

• Italy
  • Roma
    • Roma, Roma, Italy, 00161
      • Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Systemically healthy, non-smoking adults with stage III or IV periodontitis and at least one residual periodontal pocket (≥5 mm) requiring surgical treatment after non-surgical therapy.

Description

Inclusion Criteria:

• Age 18-75 years
• Full Mouth Plaque Score (FMPS) <15% at re-evaluation
• Full Mouth Bleeding Score (FMBS) <15% at re-evaluation
• At least one site with probing depth (PPD) ≥5 mm after non-surgical therapy
• Written informed consent
• Good compliance throughout periodontal therapy

Exclusion Criteria:

• Pregnancy or breastfeeding
• Use of systemic or local antibiotics in the previous 3 months
• Smoking
• Use of anti-inflammatory or anticoagulant/antiplatelet drugs
• Systemic, cardiovascular, or infectious diseases affecting periodontal health
• Dental contraindications to surgery (fractures, untreated endodontic lesions, mobility > grade 2, or faulty restorations)
• Non-compliant patients
• History of periodontal therapy in the previous year
• Ongoing orthodontic treatment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Periodontitis patients with residual periodontal pockets; Systemically healthy, non-smoking adults with stage III or IV periodontitis and at least one residual periodontal pocket (≥5 mm) requiring surgical treatment after non-surgical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathological characterization of granulation tissue components	Semiquantitative analysis (0-4 scale) of epithelial, subepithelial connective, deep connective, inflammatory, and osseous components in GT samples.	At time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between GT composition and clinical outcomes	Assessed through statistical association analysis with probing depth reduction, clinical attachment gain and defect type	At time of surgery

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: periodontitis; granulation tissue
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: 6997 (Duke legacy protocol number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be made publicly available. De-identified data may be shared upon reasonable request, following ethical and institutional regulation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No