Evaluation of efficacy of n-butyl 2 cyanoacrylate in intra-oral soft tissue closure in alveoloplasty: Clinical split-mouth comparative study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intra-operative ease of closure of the surgical site and efficient hemostasis with use of cyanoacrylate glue.
研究概览
简要总结
This is a split-mouth comparative, clinical and prospective study of patients undergoing alveoloplasty reporting to the Department of Oral and Maxillofacial Surgery, SDS, KVV. Patients with bony spicules/protuberances indicated for alveoloplasty will be enrolled for the study.
All patients requiring alveoloplasty, fulfilling inclusion criteria and giving consent for the study will be included in study, after the approval of ethical committee. The participants will be analysed on the basis of bony spicules present on both sides of either maxilla or mandible. For this study, a split-mouth, comparative analysis will be done by the division of two operative sites; i.e. Site A (Control site) and Site B (Study site).
SITE A (Control site) will get treated with (closure with 3-0 silk suture) and
SITE B (Study site) will get treated with (closure with N-butyl 2 cyanoacrylate glue)
The right side of the arch will be taken as control site while the left will be study site.
Post-operatively, clinical assessment will be performed at immediate 3rd, 7th, 14th and 21st day post-operatively.
Parameters to be evaluated will include:
Intra-orally:
The time of intra-oral wound closure (in mins) will be divided by the length of incision margin taken (in mm) to evaluate the mean time taken to achieve intra-oral incision closure depending the length of incision.
Post-operatively:
The evaluation of pain assessment (by VAS Scale) and wound healing index score by Landry, Turnbull and Howley.
Clinical evaluation of the surgical sites will be done by blinded observer on 14th and 21st post-operative days.
All post-operative parameters will be recorded on 3rd, 7th, 14th and 21st follow-up days respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both genders aged between 30-70 years.
- •Patients indicated for alveoloplasty.
- •Patients non-allergic to cyanoacrylates and silk.
- •Patients willing for participation in the study and give written informed consent.
- •Patients indicated for alveoloplasty in both sides of either maxilla or mandible.
排除标准
- •Patients who are allergic to cyanoacrylates and silk.
- •Patients out of the age range of 30-70 years.
- •Patients with compromised systemic health.
- •uncontrolled diabetes, severe cardiovascular diseases or immunocompromised patients
- •Patients on steroid therapy etc.
- •Inadequate bone volume, active infections, poor oral hygiene, haemorrhagic disorders, severe anxiety, psychological disorders.
- •Chronic smoking habit, pregnancy and recent radiation therapy.
结局指标
主要结局
Intra-operative ease of closure of the surgical site and efficient hemostasis with use of cyanoacrylate glue.
时间窗: Follow up: | Clinical assessment will be performed at immediate post-operatively, 3rd, 7th, 14th and 21st days post-operatively.
次要结局
- Effective wound healing, lesser pain & no suture tracks evident on operative site, post-operatively,(can be used as relevantly as conventional method of wound closure, that is, suturing)
研究者
Simran Arawattigi
Krishna Vishwa Vidyapeeth, Karad