The Effect of Collagen Sponge Placed in the Socket After Surgical Extraction of Mandibular Third Molars on the Incidence of Alveolar Osteitis. A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pre-extraction Pain score
研究概览
简要总结
The goal of this randomized controlled trial is to compare pain, mouth opening, and alveolar osteitis following surgical extraction of bilateral symmetrical impacted lower third molars using two types of wound closures. Collagen plugs will be applied in the sockets of the study side followed by suture, while the controlled side will be sutured without a collagen plug. The study will include 40 patients aged between 18- 40 years old, medically fit (ASA1), who have bilateral symmetrical impacted lower third molars and visit the oral surgery clinics of King Saud Medical City for extraction. The main question is" Does intra-alveolar collagen application after surgical extraction of impacted lower third molars reduce the incidence of alveolar osteitis?
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
- Single (Participant)
盲法说明
The participants (patients) will not be informed about which side will recieve the collagen
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Forty patients aged between 18- 40 years old, ASA1, who have bilateral symmetrical impacted lower third molars and visit the oral surgery clinics of King Saud Medical City for extraction.
排除标准
- •Uncontrolled systemic diseases, diabetes, bone diseases, smokers, epinephrine contraindications, pregnant women, breastfeeding women, and those who were using oral contraceptives.
- •Other exclusion criteria are the presence of acute infection and facial swelling, cystic lesions, and TMJ problems. Moreover, any surgical extraction that lasts more than 30 minutes +/- 5 minutes, or has been done without the whole standardized steps will be excluded.
结局指标
主要结局
Pre-extraction Pain score
时间窗: Pre-extraction
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Pain score Day3
时间窗: 3 days after extraction
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
Halitosis Day7
时间窗: 7 days after extraction
Halitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech
Pre-extraction Mouth opening
时间窗: Pre-extraction
Maximum Mouth opening is taken by a caliber
Pre-extraction Halitosis
时间窗: Pre-extraction
Halitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech
Mouth opening Day7
时间窗: 7 days after extraction
Maximum Mouth opening is taken by a caliber
Alveolar osteitis
时间窗: After 3 days of extraction
is diagnosed if the patient complains of pain (more than 5) between day 2 and day 4 with empty sockets and food debris, with or without halitosis
Pain score Day7
时间窗: 7 days after extraction
Pain measurement by VAS (0-10). 0: no pain. 10: worst pain
次要结局
未报告次要终点
研究者
Nedal Abu-Mostafa
Assistant Professor in Oral and Maxillofacial Surgery
Riyadh Colleges of Dentistry and Pharmacy