Influence of Early Wound Healing on the Outcomes of Regenerative Periodontal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Periodontal Regenerative Therapy.
- Who it may be relevant to
- Registry conditions: Intrabony Periodontal Defect, Wound Healing. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Influence of Early Wound Healing on the 12-month Clinical and Radiographic Outcomes of Regenerative Periodontal Surgery: a Prospective Observational Cohort Study
Overview
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
- 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).
Primary outcome measures
- Change in Clinical Attachment Level (CAL). [Time frame: Baseline and 12 months.]
Secondary outcome measures (8)
- Composite healing index (CHI) [Time frame: 1 and 2 weeks]
- Probing Pocket Depth (PPD) Change: [Time frame: Baseline and 12 months.]
- Early Wound Healing Index (EHI) [Time frame: 1 and 2 weeks]
- Change in Radiographic Parameters [Time frame: Baseline and 12 months.]
- Number of analgesic tablets [Time frame: 1 and 2 weeks]
- Percentage of Sites With Bleeding on Probing (BOP) [Time frame: Baseline and 12 months]
- Composite outcome measure (COM) [Time frame: 12 months]
- Pocket closure [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Per — Rome
Identifiers
NCT: NCT07683962 · 8328