Comparative Evaluation of the Effectiveness of Gas Combination Cryotherapy (using a refrigerant spray of propane, butane and isobutane) and 5-Fluorouracil Following Enucleation and Curettage in Management of Odontogenic Keratocyst
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
| The | |
| study will be a single-blinded, randomized, hospital-based clinical study. |
The intervention study will be carried out on patients visiting the Oral and Maxillofacial Surgery outpatient department, undergoing the enucleation and curettage of OKC.
The subjects who are willing to participate in study will be selected serially during the study period as per the inclusion and exclusion criteria.
| ASSESSMENT OF |
·
- PAIN
· 2. WOUND DEHISCENCE, INFECTION AND NECROSIS
· 3. SOFT TISSUE HEALING
· 4. HARD TISSUE HEALING
· 5. RECURRENCE
· 6. NEUROSENSORY DEFICIT
·
Will be done by the Primary Investigator & the Co-Investigators
Follow-up on post-operative days 1st day,7th day, 14th, 1 month, 3 months & 8 months.
Randomization of participants into two groups will be carried out as per computer generated list of random numbers into one of two as group A and group B. Participant will not be aware of the group in which he/she is included.
· GROUP A (Control Group): Patients having OKCs who receive 5-Fluorouracil as the adjunctive therapy
· GROUP B (Study Group): Patients having OKCs who receive Gas Combination Cryotherapy (GCC) as the adjunctive therapy
Willing participants who meet the inclusion criteria will be informed about the benefits and risks associated with the procedure after which a written, valid, informed consent will be taken from all the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Any patient with a cystic lesion involving the maxilla and/or mandible in which histopathology was suggestive of KCOT/OKC pre-operatively.
- •Patients presenting with one or multiple cysts.
- •Age greater than 13
- •Minimum of 8 mm vital bone is left from the nearest border of maxilla or mandible
- •Patients with well-controlled systemic conditions.
排除标准
- •Patients who refused to give consent for being included in the study.
- •Lesions with a risk of pathological bone fracture.
研究者
Prashit Upadhyay
Nair Hospital Dental College
