Influence of Early Wound Healing on the Outcomes of Regenerative Periodontal Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Roma La Sapienza
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Periodontal Regenerative Therapy
Procedure/SurgeryAll 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).
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Periodontal Regeneration Cohort1 intervention
Trial outcomes
Primary outcomes
1
Change in Clinical Attachment Level (CAL).
Time frame
Baseline and 12 months.Secondary outcomes
1
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 weeks2
Probing Pocket Depth (PPD) Change:
Time frame
Baseline and 12 months.3
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 weeks4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov