Comparison of efficacy of intra-socket application of Nano Hydroxyapatite with Hyaluronic Acid and Collagen as graft material after surgical removal of impacted mandibular 3rd molar - A Randomized Split-Mouth Clinical Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Evaluate the efficacy of hydroxyapatite with hyaluronic acid on postoperative pain and swelling after third molar removal.
研究概览
简要总结
As the the 3rd molar disimpaction is one of the most common surgical procedure performed in Oral and Maxillofacial Surgery, there is a need to reduce the unpleasant postoperative sequelae and provide newer methods of bone regenerative grafts to enhance and hasten the bone healing.
The surgical removal of Mandibular 3rd molar is a routinely performed minor oral surgical procedure with certain postoperative sequelae affecting the quality of life for some duration This study is conducted to evaluate efficacy of Hyaluronic Acid as an adjuvant to newer generation of graft materials. The duration of the study is approximately 2 month. Group of 11 participants are included in this study who have to undergo treatment for surgical removal of mandibular third molar.
Patients will recalled for follow up in time of 1,7,15 day to evaluate post operative pain,swelling,wound healing and mouth opening. They will be recalled after 30th day after removal of tooth for radiographic evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA class 1 patient .
- •Age 18-40 years.
- •Bilateral similar impacted mandibular third molars.
排除标准
- •Patients with any bony pathologies.
- •Patients with any hormonal imbalance which affects bone healing.
- •Patients on corticosteroids or oral contraceptives.
- •Pregnant and lactating mothers.
- •Patient allergic to any of the graft materials used in this study.
- •Patients with history of deleterious habits such as alcohol consumption, smoking, etc.
结局指标
主要结局
Evaluate the efficacy of hydroxyapatite with hyaluronic acid on postoperative pain and swelling after third molar removal.
时间窗: Compare pain using the Visual Analog Scale on the 1st, 7th, and 15th postoperative days after each extraction on the same patient. | Measure swelling using gonion-lateral canthus and tragus-angle of mouth distances on the 1st, 7th, and 15th postoperative days. | Assess wound healing using Landrys Index on the 1st, 7th, and 15th postoperative days. | Evaluate mouth opening or trismus on the 1st, 7th, and 15th postoperative days. | Take OPG on the 30th day post-op to assess bone density.
Assess the effect of hyaluronic acid on trismus after third molar extraction.
时间窗: Compare pain using the Visual Analog Scale on the 1st, 7th, and 15th postoperative days after each extraction on the same patient. | Measure swelling using gonion-lateral canthus and tragus-angle of mouth distances on the 1st, 7th, and 15th postoperative days. | Assess wound healing using Landrys Index on the 1st, 7th, and 15th postoperative days. | Evaluate mouth opening or trismus on the 1st, 7th, and 15th postoperative days. | Take OPG on the 30th day post-op to assess bone density.
Compare wound healing and bone density after using hydroxyapatite with collagen or hyaluronic acid grafts post-mandibular third molar extraction
时间窗: Compare pain using the Visual Analog Scale on the 1st, 7th, and 15th postoperative days after each extraction on the same patient. | Measure swelling using gonion-lateral canthus and tragus-angle of mouth distances on the 1st, 7th, and 15th postoperative days. | Assess wound healing using Landrys Index on the 1st, 7th, and 15th postoperative days. | Evaluate mouth opening or trismus on the 1st, 7th, and 15th postoperative days. | Take OPG on the 30th day post-op to assess bone density.
次要结局
- To assess a better morbidity & decrease of post op complications by fore said parameters(follow up after 1, 7, 15)
研究者
Dr. Himanshu Jain
Yenepoya Dental college