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临床试验/CTRI/2018/05/014283
CTRI/2018/05/014283已完成Unknown

COMPARISON OF EFFICACY OF CRYOSURGERY AND LASER THERAPY IN THE TREATMENT OF ORAL LEUKOPLAKIA

Dr K N V Sai Praveen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年3月18日
适应症

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Healing of the lesion

研究概览

简要总结

The main aim of the present longitudinal comparative clinical study was to clinically evaluate the effectiveness of laser therapy and cryosurgery in the management of OL. A total of 30 subjects were included in the present study and were randomly allocated into two groups i.e., either cryo group wherein subjects were treated with cryotherapy or Laser group in which 810nm diode Laser was used for therapy. Patients were recalled for periodic review and check up at an interval of 1st, 2nd, 3rd week, 2nd and 3rd month respectively. 10cm VAS scale was used for evaluating the postoperative discomfort due to pain and Bates- Jensen Wound Assessment Tool was used to evaluate clinical wound healing. All the parameters were recorded in a specially designed proforma. Later the data was subjected to statistical analysis. Data analysis was done by using ONE WAY ANOVA for intra group variations and POST HOC TUKEY TEST for observing in depth difference between each time interval of same group. For inter group comparisons Paired t test was used. In the present study Bates-Jensen wound assessment tool with 13 components was used for assessment of clinical healing at operated site. To the best of the knowledge as evidenced in the existing scientific literature, the present study is first of its kind where all the parameters of healing were assessed and analysed. When post-operative pain was observed, it reduced by the end of 3rd week in both the groups. Healing was comparatively faster in cryo group than in Laser group. But significant number of recurrences was noticed in subjects of cryo group. In conclusion, though the results suggest that both cryosurgery and Laser therapy were effective in terms of patient comfort, owing to the number of recurrent cases recorded in the cryo group and also mild elevated post-operative edema make cryotherapy a little cumbersome to the patient. On the other hand not much recurrence and post-operative complications were observed in laser group. This suggests that Laser therapy is advantageous over cryosurgery.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with age above 20 years.
  • Lesions greater than 1 cm in diameter.
  • Patients willing to cease tobacco and alcohol habits.

排除标准

  • Patients diagnosed with systemic diseases that can interfere with healing.

结局指标

主要结局

Healing of the lesion

时间窗: Healing of the lesion using Wound healing assessment score

次要结局

  • Comfortability of the patient after the treatment(Recurrence of the lesion)

研究者

发起方
Dr K N V Sai Praveen
申办方类型
Other [self]

研究点 (1)

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