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 in patients with Stage III-IV periodontitis.

Study Overview

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

• 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 (ages 18-75) 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] >= 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; his 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 their Early Wound Healing Index (EHI) scores at 1 and 2 weeks to evaluate the impact of healing quality on 12-month clinical attachment level (CAL) and radiographic outcomes.

Procedure: Periodontal Regenerative Therapy; All subjects undergo surgical debridement of the infrabony defect followed by a regenerative approach (biologics, 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, 6 months, and 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early wound healing Classification	This system categorizes wounds into Classes (I-III) and Subclasses (A-C). The Classes define the wound closure status, with Class I indicating complete closure, Class II representing partial closure, and Class III denoting an open wound. The Subclasses assess the quality of healing by evaluating clinical signs during the hemostatic and inflammatory phase and the proliferative phase. Subclass A reflects optimal healing, Subclass B indicates sub-optimal healing, and Subclass C describes complicated healing.	1 and 2 weeks
Probing Pocket Depth (PPD) Change:		Baseline, 6 months, and 12 months.
Early Wound Healing Index (EHI)	Assessed using the Early Wound Healing Index (EHI) by Wachtel et al. 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
Change in Radiographic Linear Bone Fill	Measured in millimeters (mm) on standardized radiographs from baseline to 6 and 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, 6 months, and 12 months.
Oral Health Impact Profile-14 questionnaire	Evaluation of oral health-related quality of life using the unabbreviated Oral Health Impact Profile-14 (OHIP-14) questionnaire. The total score ranges from a minimum of 0 to a maximum of 56. Higher scores mean a worse outcome (greater negative impact on quality of life).	1 and 2 weeks
Number of analgesic tablets		1 and 2 weeks
Patient-Reported Postoperative Swelling as Assessed by a Visual Analog Scale (VAS)	Postoperative swelling evaluated by the patient using a 100-mm Visual Analog Scale (VAS). The scale ranges from 0 mm (no swelling) to 100 mm (severe swelling). Higher scores indicate worse outcomes (greater swelling).	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.	Baseline, 6 months and 12 months
Postoperative Pain/Discomfort as Assessed by a Visual Analog Scale (VAS)	Patient's self-reported surgical discomfort/pain measured using a 100-mm Visual Analog Scale (VAS). The scale ranges from 0 mm (no pain/discomfort) to 100 mm (worst possible pain). Higher scores indicate worse outcomes.	1 and 2 weeks
Patient-Reported Postoperative Estethics as Assessed by a Visual Analog Scale (VAS)	Patient's self-reported estethics measured using a 100-mm Visual Analog Scale (VAS). The scale ranges from 0 mm (worst possible estethics) to 100 mm (better possible estethics). Higher scores indicate better outcomes.	1 and 2 weeks

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 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 6, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: May 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