Influence of Early Wound Healing on the Outcomes of Regenerative Periodontal Surgery (EWH_reg)
29. juli 2026 oppdatert av: Andrea Pilloni MD DDS MS, University of Roma La Sapienza
Influence of Early Wound Healing on the 12-month Clinical and Radiographic Outcomes of Regenerative Periodontal Surgery: a Prospective Observational Cohort Study
This study investigates whether early post-surgical healing (1-2 weeks) affects the 12-month clinical and radiographic success of periodontal regenerative therapy, and identifies patient-related, site-specific, and technique-related factors associated with optimal early wound healing, in patients with Stage III-IV periodontitis.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
This single-center, prospective observational cohort study addresses two pre-specified aims: (1) the association between early wound healing at 1 and 2 weeks and 12-month clinical and radiographic outcomes; and (2) the identification of patient-related, site-related (e.g., intrabony defect depth, CEJ-to-bone-crest distance, defect configuration, intrabony defect classification), and technique-related (flap design, biomaterial) factors associated with optimal early wound healing.
Studietype
Observasjonsmessig
Registrering (Antatt)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Andrea Pilloni
- Telefonnummer: +39 3356409374
- E-post: andrea.pilloni@uniroma1.it
Studiesteder
-
-
Rome
-
Rome, Rome, Italia, 00161
- Rekruttering
- Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology
-
Ta kontakt med:
- Andrea Pilloni
- Telefonnummer: +39 3356409374
- E-post: andrea.pilloni@uniroma1.it
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The study population consists of adult patients (age >=18) diagnosed with Stage III or IV Periodontitis according to the 2017 World Workshop Classification.
These patients present with at least one deep interproximal infrabony defect requiring regenerative surgical treatment.
Participants are recruited from the patient pool of the Section of Periodontics at Sapienza University of Rome, Italy.
The population includes both systemically healthy individuals and those with well-controlled systemic conditions (ASA I or II), who have maintained optimal oral hygiene (FMPS/FMBS < 15%) following initial non-surgical periodontal therapy.
Beskrivelse
Inclusion Criteria:
- Diagnosis of Stage III or IV Periodontitis.
- Presence of at least one deep interproximal infrabony defect (Probing Pocket Depth [PPD] >= 6 mm, radiographic depth >= 3 mm).
- Optimal oral hygiene: Full-Mouth Plaque Score (FMPS) and Full-Mouth Bleeding Score (FMBS) < 15% at the time of surgery.
Exclusion Criteria:
- Systemic: ASA III-VI classification; uncontrolled diabetes; medications causing gingival overgrowth (e.g., nifedipine, cyclosporine, phenytoin); heavy smokers (>10 cigarettes/day); pregnancy or lactation.
- Local: Third molars; Grade III tooth mobility; inadequate endodontic treatment; teeth undergoing orthodontic treatment; teeth supporting removable or implant-linked fixed prosthetics.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Periodontal Regeneration Cohort
This single cohort consists of patients with Stage III-IV periodontitis presenting at least one deep vertical infrabony defect.
All patients receive periodontal regenerative surgery according to clinical indications.
The cohort will be subsequently stratified into subgroups during data analysis based on the early wound healing assessment at 1 and 2 weeks to evaluate the impact of healing quality on 12-month clinical attachment level (CAL) and radiographic outcomes and to identify patient-related, site-specific, and/or technique-related factors associated with optimal early wound healing,
|
All subjects undergo surgical debridement of the intrabony defect followed by a regenerative approach (biologics with or without bone grafts, or blood clot alone) using papilla preservation techniques (MIST, M-MIST, MPPT, SPPF, or SFA).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Clinical Attachment Level (CAL).
Tidsramme: Baseline and 12 months.
|
Baseline and 12 months.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of analgesic tablets
Tidsramme: 1 and 2 weeks
|
1 and 2 weeks
|
|
|
Early Wound Healing Index (EHI)
Tidsramme: 1 and 2 weeks
|
Assessed using the Early Wound Healing Index (EHI).
The index ranges from a minimum score of 1 (complete tissue closure without fibrin) to a maximum score of 5 (incomplete tissue closure with partial/complete necrosis).
Higher scores mean a worse clinical outcome.
|
1 and 2 weeks
|
|
Composite healing index (CHI)
Tidsramme: 1 and 2 weeks
|
CHI has two independent, dichotomous domains (wound closure and wound quality), each answering a single clinically distinct question, and reports the outcome as a two-digit composite code.
|
1 and 2 weeks
|
|
Probing Pocket Depth (PPD) Change:
Tidsramme: Baseline and 12 months.
|
Baseline and 12 months.
|
|
|
Change in Radiographic Parameters
Tidsramme: Baseline and 12 months.
|
Measured in millimeters (mm) or degrees (°) on standardized radiographs from baseline to 12 months.
It calculates the distance from a fixed reference point (e.g., cementoenamel junction) to the bottom of the bony defect.
A positive change (increase in mm) indicates bone gain (better outcome).
|
Baseline and 12 months.
|
|
Percentage of Sites With Bleeding on Probing (BOP)
Tidsramme: Baseline and 12 months
|
Presence or absence of bleeding assessed within 30 seconds of probing at specific sites.
The data will be aggregated and reported as the percentage of sites showing bleeding out of the total sites examined.
Higher percentages indicate worse outcomes.
|
Baseline and 12 months
|
|
Composite outcome measure (COM)
Tidsramme: 12 months
|
Proportion of sites achieving a combination of PPD ≤ 4 mm and CAL gain ≥ 3 mm
|
12 months
|
|
Pocket closure
Tidsramme: 12 months
|
Proportion of sites achieving a combination of PPD ≤ 4 mm and absence of bleeding on probing
|
12 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. oktober 2027
Studiet fullført (Antatt)
1. oktober 2027
Datoer for studieregistrering
Først innsendt
7. mai 2026
Først innsendt som oppfylte QC-kriteriene
28. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 8328
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .