Influence of Early Wound Healing on the Outcomes of Regenerative Periodontal Surgery (EWH_reg)

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Healing; Intrabony Periodontal Defect
• Intervention / Treatment: Procedure: Periodontal Regenerative Therapy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Andrea Pilloni; Phone Number: +39 3356409374; Email: andrea.pilloni@uniroma1.it

Study Locations

• Italy
  • Rome
    • Rome, Rome, Italy, 00161
      • Recruiting
      • Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology
      • Contact: Andrea Pilloni; Phone Number: +39 3356409374; Email: andrea.pilloni@uniroma1.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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,

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Clinical Attachment Level (CAL).	Baseline and 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of analgesic tablets		1 and 2 weeks
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.	1 and 2 weeks
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.	1 and 2 weeks
Probing Pocket Depth (PPD) Change:		Baseline and 12 months.
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).	Baseline and 12 months.
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.	Baseline and 12 months
Composite outcome measure (COM)	Proportion of sites achieving a combination of PPD ≤ 4 mm and CAL gain ≥ 3 mm	12 months
Pocket closure	Proportion of sites achieving a combination of PPD ≤ 4 mm and absence of bleeding on probing	12 months

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 31, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: early wound healing; periodontal regeneration
• Other Study ID Numbers: 8328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No