Granulation Tissue From Residual Periodontal Pockets | NCT07587606

Studies
Granulation Tissue From Residual Periodontal Pockets

NCT07587606

Sponsor

University of Roma La Sapienza

Status

Enrolling by invitation

Last Update Posted

May 14, 2026Actual

Enrollment

21Estimated

Phase

Not provided

Conditions

Periodontitis

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 7, 2026Actual

Primary Completion Date

Jul 15, 2026Estimated

Completion Date

Jul 30, 2026Estimated

First Submitted Date

May 7, 2026

First Submission Date that Met QC Criteria

May 7, 2026

First Posted Date

May 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2026

Last Update Posted Date

May 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

21Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology		Roma	Roma	00161	Italy

IPD Sharing Statement Module

Plan to Share IPD

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

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Browse Branches

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