An observational study in Intrabony Periodontal Defect and Wound Healing, sponsored by University of Roma La Sapienza. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by University of Roma La Sapienza · Observational
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.
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.
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.
Exclusion Criteria:
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,
Procedure: Periodontal Regenerative Therapy
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).
Change in Clinical Attachment Level (CAL).
Time frame: Baseline and 12 months.
Composite healing index (CHI)
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.
Time frame: 1 and 2 weeks
Probing Pocket Depth (PPD) Change:
Time frame: Baseline and 12 months.
Early Wound Healing Index (EHI)
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.
Time frame: 1 and 2 weeks
Change in Radiographic Parameters
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).
Time frame: Baseline and 12 months.
Number of analgesic tablets
Time frame: 1 and 2 weeks
Percentage of Sites With Bleeding on Probing (BOP)
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.
Time frame: Baseline and 12 months
Composite outcome measure (COM)
Proportion of sites achieving a combination of PPD ≤ 4 mm and CAL gain ≥ 3 mm
Time frame: 12 months
Pocket closure
Proportion of sites achieving a combination of PPD ≤ 4 mm and absence of bleeding on probing
Time frame: 12 months
Plan to share: Undecided
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University of Roma La Sapienza