Granulation Tissue From Residual Periodontal Pockets

NCT07587606 | Enrolling By Invitation

• 1 other identifier: 6997
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis

Keywords

periodontitis; granulation tissue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between GT composition and clinical outcomes

  At time of surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology

Roma, Roma, 00161, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

granulation tissue from periodontal pockets (formalin-fixed paraffin-embedded tissue)

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 14, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 14, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)