Influence of Early Wound Healing on the Outcomes of Regenerative Periodontal Surgery (EWH_reg)
29. juli 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Andrea Pilloni
- Telefonnummer: +39 3356409374
- E-mail: andrea.pilloni@uniroma1.it
Studiesteder
-
-
Rome
-
Rome, Rome, Italien, 00161
- Rekruttering
- Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology
-
Kontakt:
- Andrea Pilloni
- Telefonnummer: +39 3356409374
- E-mail: andrea.pilloni@uniroma1.it
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Clinical Attachment Level (CAL).
Tidsramme: Baseline and 12 months.
|
Baseline and 12 months.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of analgesic tablets
Tidsramme: 1 and 2 weeks
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1 and 2 weeks
|
|
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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
|
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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.
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Baseline and 12 months.
|
|
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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).
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Baseline and 12 months.
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Percentage of Sites With Bleeding on Probing (BOP)
Tidsramme: Baseline and 12 months
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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
|
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Composite outcome measure (COM)
Tidsramme: 12 months
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Proportion of sites achieving a combination of PPD ≤ 4 mm and CAL gain ≥ 3 mm
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12 months
|
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Pocket closure
Tidsramme: 12 months
|
Proportion of sites achieving a combination of PPD ≤ 4 mm and absence of bleeding on probing
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. oktober 2027
Studieafslutning (Anslået)
1. oktober 2027
Datoer for studieregistrering
Først indsendt
7. maj 2026
Først indsendt, der opfyldte QC-kriterier
28. juni 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 8328
Plan for individuelle deltagerdata (IPD)
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