Influence of Early Wound Healing on the 12-month Clinical and Radiographic Outcomes of Regenerative Periodontal Surgery: a Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Clinical Attachment Level (CAL).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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,
干预措施: Periodontal Regenerative Therapy (Procedure)
结局指标
主要结局
Change in Clinical Attachment Level (CAL).
时间窗: Baseline, 6 months, and 12 months.
Change in Clinical Attachment Level (CAL).
时间窗: Baseline and 12 months.
次要结局
- Early wound healing Classification(1 and 2 weeks)
- Probing Pocket Depth (PPD) Change:(Baseline, 6 months, and 12 months.)
- Change in Radiographic Linear Bone Fill(Baseline, 6 months, and 12 months.)
- Oral Health Impact Profile-14 questionnaire(1 and 2 weeks)
- Number of analgesic tablets(1 and 2 weeks)
- Patient-Reported Postoperative Swelling as Assessed by a Visual Analog Scale (VAS)(1 and 2 weeks)
- Percentage of Sites With Bleeding on Probing (BOP)(Baseline, 6 months and 12 months)
- Postoperative Pain/Discomfort as Assessed by a Visual Analog Scale (VAS)(1 and 2 weeks)
- Patient-Reported Postoperative Estethics as Assessed by a Visual Analog Scale (VAS)(1 and 2 weeks)
- Early Wound Healing Index (EHI)(1 and 2 weeks)
- Composite healing index (CHI)(1 and 2 weeks)
- Probing Pocket Depth (PPD) Change:(Baseline and 12 months.)
- Change in Radiographic Parameters(Baseline and 12 months.)
- Percentage of Sites With Bleeding on Probing (BOP)(Baseline and 12 months)
- Composite outcome measure (COM)(12 months)
- Pocket closure(12 months)
研究者
Andrea Pilloni MD DDS MS
Professor
University of Roma La Sapienza