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Enrolling by Invitation

NCT Number: NCT07587606

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Roma, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Histopathological characterization of granulation tissue components

    Time frame: At time of surgery

    Semiquantitative analysis (0-4 scale) of epithelial, subepithelial connective, deep connective, inflammatory, and osseous components in GT samples.

Secondary outcomes

  1. Correlation between GT composition and clinical outcomes

    Time frame: At time of surgery

    Assessed through statistical association analysis with probing depth reduction, clinical attachment gain and defect type

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Histological Analysis of Granulation Tissue From Residual Periodontal Pockets

Acronym: GTRP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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