Treatment of Mandibular Class II Furcation With Different Types of Biomaterials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Horizontal Bone Gain (HBG).
研究概览
简要总结
This randomized controlled clinical trial aims to determine which biomaterial combination yields superior clinical and tomographic outcomes in the treatment of mandibular class II furcation defects. In addition, modifications of gingival phenotype in the furcation area will be assessed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adults diagnosed with Stage III or Stage IV periodontitis presenting with at least one mandibular molar with a Class II furcation defect requiring regenerative surgical treatment.
- •Ability and willingness to provide written informed consent.
- •Medically stable and able to undergo periodontal surgery.
- •Willingness to comply with all study procedures and follow-up visits.
排除标准
- •Stage I or Stage II periodontitis.
- •Current smokers.
- •Uncontrolled diabetes mellitus.
- •Alcohol or substance use disorder.
- •Chronic inflammatory diseases requiring continuous anti-inflammatory therapy.
- •Current use of bisphosphonates or other medications associated with medication-related osteonecrosis of the jaw.
- •Current use of medications known to induce gingival enlargement.
- •Continuous use of systemic antibiotics or anti-inflammatory medications.
- •Pregnant or breastfeeding individuals.
- •Known allergy or hypersensitivity to the antibiotics, local anesthetics, or other study-related medications.
- •Medical conditions that, in the investigator's judgment, make the participant unsuitable for periodontal surgery or study participation.
结局指标
主要结局
Horizontal Bone Gain (HBG).
时间窗: 6 months
Cone-beam computed tomography (CBCT) measurements will be obtained at baseline and 6 months from the buccal or lingual bone edge to the deepest bone defect, measured horizontally. Sites will be classified as buccal or lingual and analyzed at the site level, first pooled and then separately. Change scores (6 months-baseline) will be assessed using the Shapiro-Wilk test. Within-group changes will be analyzed with paired t-tests or Wilcoxon signed-rank tests, as appropriate. Between-group comparisons of baseline values and 6-month changes will be performed using one-way ANOVA with Tukey's HSD or Kruskal-Wallis with Dunn's test (Holm adjustment). To account for multiple sites per participant, primary bone outcomes will be analyzed using linear mixed-effects models or generalized estimating equations when required. Statistical significance will be set at P\<0.05. Analyses will be performed in Python 3 (pandas, SciPy, statsmodels).
次要结局
- Improvement of the Gingival Phenotype(6 months)