PeriodontitisGTRPNCT07587606
Granulation Tissue From Residual Periodontal Pockets
An observational study of Periodontitis, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Periodontitis
- Type of treatment
- Injection or infusion
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 7 May 2026to 30 Jul 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Non-compliant patients
- History of periodontal therapy in the previous year
- Ongoing orthodontic treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology
Roma, Roma, 00161
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis
- Keywords
- periodontitis, granulation tissue
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Histopathological characterization of granulation tissue components
Semiquantitative analysis (0-4 scale) of epithelial, subepithelial connective, deep connective, inflammatory, and osseous components in GT samples.
Measured: At time of surgery
Secondary outcomes (1)
Correlation between GT composition and clinical outcomes
Assessed through statistical association analysis with probing depth reduction, clinical attachment gain and defect type
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start7 May 2026
- Primary completion15 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Pilloni MD DDS MS, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587606
- Sponsor's protocol ID
- 6997
- Acronym
- GTRP
- Status last verified
- May 2025
- First submitted
- 7 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Analysis of Granulation Tissue From Residual Periodontal Pockets
- ClinicalTrials.gov ID
- NCT07587606
- Acronym / sponsor ID
- GTRP / 6997
- Conditions
- Periodontitis
- Keywords
- periodontitis, granulation tissue
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Correlation between GT composition and clinical outcomes
Time frame: At time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathological characterization of granulation tissue components (time frame: At time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.