An observational study in Periodontitis, sponsored by University of Roma La Sapienza. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University of Roma La Sapienza · Observational
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's planned enrollment of 21 is below the median of 90 across 428 observational studies indexed under Periodontitis.
Browse Periodontitis studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
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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.
Exclusion Criteria:
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.
Histopathological characterization of granulation tissue components
Semiquantitative analysis (0-4 scale) of epithelial, subepithelial connective, deep connective, inflammatory, and osseous components in GT samples.
Time frame: At time of surgery
Correlation between GT composition and clinical outcomes
Assessed through statistical association analysis with probing depth reduction, clinical attachment gain and defect type
Time frame: At time of surgery
Plan to share: No — Individual participant data (IPD) will not be made publicly available. De-identified data may be shared upon reasonable request, following ethical and institutional regulation
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University of Roma La Sapienza