Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery: A Randomized Controlled 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
- Distal periodontal tissue status
研究概览
简要总结
Impacted mandibular third molars can cause various complications to the adjacent second molars, such as dental caries, periodontitis, or root resorption. These complications often progress silently and asymptomatically. A typical scenario involves a mesioangularly impacted third molar exerting pressure on the distal alveolar bone of the second molar, resulting in persistent food impaction that is difficult for patients to clean. Furthermore, the surgical removal of deeply impacted or severely angulated mandibular third molars often requires bone removal in the area adjacent to the second molar. These factors may exacerbate distal periodontal defects of the second molar, especially in individuals over the age of 25. This research focuses on evaluating the effectiveness of a new-generation collagen membrane in promoting healing after the extraction of impacted mandibular third molars in patients at risk of distal periodontal tissue damage to the second molars
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 25 years or older.
- •Patients with mesioangular or horizontally impacted mandibular third molars. The highest point of mandibular third molars are lower than the occlusal surface of adjacent second molars (classified B, C according to Pell - Gregory's category).
- •Patients with symmetrical lower third molars on both sides with same classification according to Pell - Gregory's category. The difference of third molars inclination on both side is not more than 15°.
- •Patients with lower second molars on both sides have no cavities or fillings that affect the determination of the cemento-enamel junction.
- •Patients are explained, counseled clearly and sign their consent to participate in the study.
排除标准
- •Patients with coagulation or immune disorders.
- •Patients allergic to local anesthetics (Lidocaine 2% with Adrenaline 1:100,000) or any drugs used in the study.
- •Patients allergic to products or food derived from pigs.
- •Pregnant or breastfeeding patients.
- •Patients who smoke.
- •Patients with systemic conditions that contraindicate surgical procedures.
- •Patients with clinical or radiographic signs suggestive of tumors (benign or malignant) associated with or in proximity to the mandibular third molar.
- •Patients with missing mandibular second molars.
研究组 & 干预措施
study
apply collagen membrane on distal surface of second molar after third molar surgery
干预措施: collagen membrane (Procedure)
control
standard third molar surgery without any application
干预措施: third molar surgery (Procedure)
结局指标
主要结局
Distal periodontal tissue status
时间窗: preoperative (T0), 3rd moth after surgery (T3) and 6th month after surgery (T6)
distal periodontal tissue status was assessed using variables of pocket depth
次要结局
- Distal bone level(at the time of the end of surgery (T0'), 3rd month after surgery (T3), and 6th month after surgery (T6).)
研究者
Lam Cu Phong
lecturer, clinical professor
University of Medicine and Pharmacy at Ho Chi Minh City