Impact of Root Surface Conditioning With Erythritol Air Polishing Versus Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Root Coverage (MRC, %)
研究概览
简要总结
This study aims to evaluate whether the method of root surface preparation influences surgical outcomes. It will assess whether manual root instrumentation can be replaced by a less invasive erythritol air-polishing technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Multiple RT1 and/or RT2 gingival recessions, symmetrical and bilateral, with a minimum height of ≥ 1 mm
- •Full-mouth plaque score (FMPS) < 15% (assessed on four surfaces per tooth)
- •Full-mouth bleeding on probing (FMBOP) < 15% (assessed on four surfaces per tooth)
- •Detectable cemento-enamel junction (CEJ)
- •Age ≥ 18 years
排除标准
- •RT3 gingival recessions
- •Gingival recessions affecting second and third molars
- •Systemic or infectious diseases that may impair wound healing, including active malignancy, diabetes mellitus with HbA1c > 7.0%, history of head and neck radiotherapy, true xerostomia, and HIV/AIDS
- •Cervical caries, non-carious cervical lesions, or Class V restorations interfering with the CEJ
- •Active periodontitis
- •Use of medications affecting periodontal tissues or wound healing, including systemic corticosteroids, immunosuppressants, isotretinoin, bisphosphonates, and monoclonal antibodies with immunosuppressive, antiresorptive, or antiangiogenic effects
- •Pregnancy or breastfeeding
研究组 & 干预措施
Erythritol Air-Polishing
Sites with gingival recessions treated with root surface preparation using erythritol air-polishing prior to modified tunnel technique with subepithelial connective tissue graft.
干预措施: Erythritol Air-Polishing (Procedure)
Manual Root Instrumentation
Sites with gingival recessions treated with root surface preparation using manual Gracey curettes prior to modified tunnel technique with subepithelial connective tissue graft.
干预措施: Manual Root Instrumentation (Procedure)
结局指标
主要结局
Mean Root Coverage (MRC, %)
时间窗: 6 months and 12 months post-surgery
Mean root coverage (MRC), expressed as a percentage (%), assessed at 6 and 12 months post-surgery. MRC is calculated as (GR₀ - GR₆) / GR₀ × 100% and (GR₀ - GR₁₂) / GR₀ × 100%, respectively. Gingival recession (GR), measured in millimeters (mm) as the distance from the cemento-enamel junction (CEJ) to the gingival margin at the mid-buccal aspect of the tooth, is used solely as an input parameter for the calculation of MRC.
次要结局
- Gingival recession height (GRH, mm)(baseline, 6 months, and 12 months post-surgery)
- Gingival recession width (RW, mm)(baseline, 6 months, and 12 months post-surgery)
- Clinical Attachment Level (CAL, mm)(Baseline; 6 and 12 months post-surgery)
- Probing Pocket Depth (PPD, mm)(baseline, 6 months, and 12 months post-surgery)
- Gingival Thickness (GT, mm)(baseline, 6 months, and 12 months post-surgery)
- Keratinized tissue width (KTW, mm)(baseline, 6 months, and 12 months post-surgery)
- Complete Root Coverage (CRC, %)(6 months and 12 months post-surgery)
- Gingival Recession Reduction (GR red, mm)(6 months and 12 months post-surgery)
- Clinical Attachment Level Gain (CAL Gain, mm)(6 months and 12 months post-surgery)
- Keratinized Tissue Width Gain (KTW Gain, mm)(6 months and 12 months post-surgery)
- Tooth Sensitivity (SEN, Schiff score)(Assessed on the day of surgery before administration of anesthesia, and subsequently at 6 and 12 months after surgery.)
- Root Esthetic Score (RES, score)(6 and 12 months after surgery)
- Discomfort during the procedure (VAS, 0-10)(Immediately after completion of the procedure)
- Pain intensity (VAS scale, 0-10)(1, 2, 4, 7, 14 days after procedure)
- Postoperative swelling (VAS scale, 0-10)(1, 2, 4, 7, 14 days after procedure)
- Tooth sensitivity (VAS, 0-10)(1, 2, 4, 7, and 14 days post-procedure)
- Gingival color (VAS, 0-10)(6 and 12 months post-surgery)
- Gingival shape (VAS 0-10)(6 and 12 months post-surgery)
- Tooth appearance (VAS, 0-10)(6 and 12 months post-surgery)