Intrabony Periodontal Defect, Wound Healing
Conditions
Keywords
periodontal regeneration, early wound healing
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.
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.
Interventions
PROCEDUREPeriodontal 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).
Sponsors
University of Roma La Sapienza
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Clinical Attachment Level (CAL). | Baseline and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite healing index (CHI) | 1 and 2 weeks | 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. |
| Probing Pocket Depth (PPD) Change: | Baseline and 12 months. | — |
| Early Wound Healing Index (EHI) | 1 and 2 weeks | 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. |
| Change in Radiographic Parameters | Baseline and 12 months. | 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). |
| Number of analgesic tablets | 1 and 2 weeks | — |
| Percentage of Sites With Bleeding on Probing (BOP) | Baseline and 12 months | 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. |
| Composite outcome measure (COM) | 12 months | Proportion of sites achieving a combination of PPD ≤ 4 mm and CAL gain ≥ 3 mm |
| Pocket closure | 12 months | Proportion of sites achieving a combination of PPD ≤ 4 mm and absence of bleeding on probing |
Countries
Italy
Contacts
CONTACTAndrea Pilloni
Outcome results
None listed