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临床试验/CTRI/2023/05/052243
CTRI/2023/05/052243已完成不适用

Wound Healing and Pain Assessment Following Low Level Laser Therapy After gingivectomy procedure: A Randomized Controlled Clinical Trial

Dr Kshipra P Kawadkar1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2023年8月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
1
主要终点
3)To measure degree of keratinization after scalpel gingivectomy and LLLT versus Scalpel gingivectomy alone.

研究概览

简要总结

Low-level laser therapy (LLLT) focused on bio stimulation/biomodulation effect, at specific wavelength, leads to modification of cellular activities.

Aim: This split-mouth study was used to assess effect of LLLT after scalpel gingivectomy, using diode laser on patient’s pain response; immediately after wearing off of local anesthetic effect; on first day followed by wound healing and degree of keratinization on third day, 15th day and after one month post-operatively.

Materials and methods: Thirteen patients with twenty-six sites exhibiting gingival enlargement in maxillary and mandibular regions will be included. Following scalpel gingivectomy, diode laser with 980 nm wavelength at 3W power in pulsed non-contact mode at gingivectomy treatment function will be used.  Test region tissues (randomly allotted by lottery method) will be lased 1-2 cm away from surgical wound on the day of gingivectomy. Surgical areas of control and test groups will be disclosed with methylene blue to visualize the areas where the epithelium was present.

Results: LLLT�’applied sites will be compared statistically with control surgical sites in terms of Wong Bakers faces pain scale, Huang et al.’s wound healing index and degree of keratinization.

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 Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Cases indicated for gingivectomy procedure in maxillary and mandibular anterior region.
  • Inflammatory and non-inflammatory gingival enlargement excluding drug induced enlargements.
  • Patients with no systemic diseases and have no history of medication in last six months.
  • Participants having good oral hygiene.
  • Patient willing to participate in the research.

排除标准

  • Pregnancy 2)History of any drug usage affecting the periodontium for the past 6 months 3)Previous periodontal treatment for the last 6 months 4)Patient with bleeding disorders 5)Smoking 6)Teeth with untreated caries, endodontic lesions and grade II or more mobility 7)Subjects with Acute exacerbation of periodontitis, herpetic lesions and Necrotizing Ulcerative Periodontitis (NUG) 8)Uncooperative patients.

结局指标

主要结局

3)To measure degree of keratinization after scalpel gingivectomy and LLLT versus Scalpel gingivectomy alone.

时间窗: 1st day, 3rd day, 15th day and 1 month

1)To evaluate pain response after scalpel gingivectomy and LLLT versus Scalpel gingivectomy alone.

时间窗: 1st day, 3rd day, 15th day and 1 month

2)To assess wound healing after scalpel gingivectomy and LLLT versus Scalpel gingivectomy alone.

时间窗: 1st day, 3rd day, 15th day and 1 month

次要结局

未报告次要终点

研究者

发起方
Dr Kshipra P Kawadkar
申办方类型
Other [self-sponsored]

研究点 (1)

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