Influence of Early Wound Healing on the Outcomes of Regenerative Periodontal Surgery

NCT07683962 | Recruiting

• 1 other identifier: 8328
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrabony Periodontal Defect; Wound Healing

Keywords

periodontal regeneration; early wound healing

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Attachment Level (CAL).

  Baseline and 12 months.

Secondary Outcomes (8)

• Composite healing index (CHI)

  1 and 2 weeks

• Probing Pocket Depth (PPD) Change:

  Baseline and 12 months.

• Early Wound Healing Index (EHI)

  1 and 2 weeks

• Change in Radiographic Parameters

  Baseline and 12 months.

• Number of analgesic tablets

  1 and 2 weeks

Study Arms (1)

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

Interventions

Periodontal Regenerative Therapy PROCEDURE

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).

Periodontal Regeneration Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology

Rome, Rome, 00161, Italy

RECRUITING

Central Study Contacts

Andrea Pilloni

CONTACT

+39 3356409374; andrea.pilloni@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

IT (1)