EFFICACY OF CURCUMIN (CURCUMA LONGA) AS AN ADJUVANT THERAPEUTIC AGENT AFTER SURGICAL REMOVAL OF IMPACTED MANDIBULAR THIRD MOLAR. A SPLIT MOUTH STUDY
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1)pain assessment
研究概览
简要总结
A total no. of 40 participants to be recruited in the study . Each patient will sign an informed consent form after receiving a thorough explanation regarding
the study. The patients requiring surgical removal of similar impacted bilateral mandibular third molars
will be chosen as per inclusion and exclusion criteria as the study subjects.
Surgical site will be randomly divided into two groups-Group A and Group B
Group A-Surgical site where crushed curcumin tablet(250mg) will be placed (Study group).
Group B-Surgical site which will undergo natural healing (Control group).
After intervention in the groups. the following parameters are assessed
· Pain assessment: : Pain intensity will be assessed using a 10-point Numerical rating scale of score ranging from “0†no pain to severe/unbearable pain “10â€. The severity of pain will be evaluated postoperatively after 3days and 1 week.
· Soft tissue healing assessment: Soft tissue healing will be assessed by colour of gingiva, bleeding on palpation, epithelization of margins and presence of suppuration. The quality of soft tissue healing will be clinically evaluated at 3, 7, 14 and 21 days postoperatively using Healing Index modified.
· For the assessment of Oedema: On 3rd and 7thday post-operatively, according to the study done by Kocer et al , oedema is evaluated using three facial lines
· (1) the distance from external canthus of the eye to the gonion angle (LC-Go)
(2) the distance from lower border of the tragus to the mouth commissure on the operated
side (Tr-C)
(3) the distance from lower border of the tragus to the soft pogonion (Tr-Pog)
For the assessment of Maximal inter-incisal opening: pre and post operative maximal inter-incisal opening (MIO) measurements are recorded on 3rd and 7th day using a Vernier caliper
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, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged between 18-65 years with similar impacted bilateral mandibular third molars undergoing extractions at two different intervals.
- •2.Patients classified under ASA I and ASA II requiring surgical extraction of similar impacted bilateral mandibular third molars 3.Selected patients will be non-smokers.
排除标准
- •1.Patients with poor oral hygiene.
- •2.Diseases of oral mucosa.
- •3.Patients with history of radiation therapy 4.Pregnant patients.
- •5.Patients with psychiatric illness.
- •6.Patients classified under ASA III and ASA IV.
结局指标
主要结局
1)pain assessment
时间窗: 1)pain assessment on 3rd and 7th day | 2)oedema assessment on 3rd and 7th day | 3)soft tissue healing (3rd,7th,14th,21st days) | 4)maximal interincisal opening(3rd and 7th day)
2)oedema assessment
时间窗: 1)pain assessment on 3rd and 7th day | 2)oedema assessment on 3rd and 7th day | 3)soft tissue healing (3rd,7th,14th,21st days) | 4)maximal interincisal opening(3rd and 7th day)
3)soft tissue healing
时间窗: 1)pain assessment on 3rd and 7th day | 2)oedema assessment on 3rd and 7th day | 3)soft tissue healing (3rd,7th,14th,21st days) | 4)maximal interincisal opening(3rd and 7th day)
4)maximal interincisal opening
时间窗: 1)pain assessment on 3rd and 7th day | 2)oedema assessment on 3rd and 7th day | 3)soft tissue healing (3rd,7th,14th,21st days) | 4)maximal interincisal opening(3rd and 7th day)
次要结局
- alveolar osteitis(7days)
研究者
Spoorthi Prabhu
Rajarajeswari dental college and hospital