Evaluation of healing of extraction socket with and without Naturally Sourced (Eggshell derived) Nano-hydroxyapatite graft - A prospective study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- •Soft Tissue Healing using Modified Laundry et al. Index
研究概览
简要总结
This study is a randomized,parallel group trial evaluating the healing of extraction socket with andwithout eggshell derived nanohydroxyapatite graft and will be conducted in thedepartment of Clinical Research. The study subjects will be enrolled from theout-patient department of Oral and Maxillofacial Surgery. They will be randomlyallocated into two groups and the consent will be obtained from theparticipants. The study participants will undergo atraumatic extraction. Afterachievement of post extraction hemostasis, nano-hydroxyapatite graft will beplaced into the extraction socket till the crestal level in one group. Inanother group, pressure pack is applied to the extraction socket. After theprocedure, the subjects will be advised to follow post extraction instructions.All the subjects will be followed up for 90 days for any adverse events and theparameters like soft tissue healing, pain and alveolar width and height will beassessed on 7th, 14th and 90th-day post operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between l8-45 years with physical status falling under the category of ASA I and II.
- •Patients undergoing atraumatic extraction for grossly decayed or non-restorable teeth or periodontally weakened teeth.
- •Extraction sites that do not require primary closure or suturing.
- •Subjects who are willing to take part in the study.
排除标准
- •Any abnormal findings during clinical or radiological examination.
- •Immunosuppressive conditions such as AIDS, Cancer or Radiation therapies.
- •Pregnant/Lactating women.
结局指标
主要结局
•Soft Tissue Healing using Modified Laundry et al. Index
时间窗: 1) On 7th day | 2) On 14th day | 3) On 90th day
•Pain using Modified Wong-Baker Faces Pain Rating Scale
时间窗: 1) On 7th day | 2) On 14th day | 3) On 90th day
•Measurement of Alveolar Height and Width
时间窗: 1) On 7th day | 2) On 14th day | 3) On 90th day
次要结局
- Patient Comfort level will be assessed after the procedure on three time points(7th, 14th and 90th day)