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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal Regenerative Therapy | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Attachment Level (CAL). | Baseline, 6 months, and 12 months. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pilloni | Contact | +39 3356409374 | andrea.pilloni@uniroma1.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology | Recruiting | Rome | Rome | 00161 | Italy |
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| 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 |