Granulation Tissue From Residual Periodontal Pockets (GTRP)
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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Roma
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Roma, Roma, Italia, 00161
- Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Histopathological characterization of granulation tissue components
Tidsramme: At time of surgery
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Semiquantitative analysis (0-4 scale) of epithelial, subepithelial connective, deep connective, inflammatory, and osseous components in GT samples.
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At time of surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Correlation between GT composition and clinical outcomes
Tidsramme: At time of surgery
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Assessed through statistical association analysis with probing depth reduction, clinical attachment gain and defect type
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At time of surgery
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 6997 (Duke legacy protocol number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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