Effects of Photobiomodulation with flap surgery versus flap surgery alone on wound healing and pain management: A randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Wound healing index (WHI)
研究概览
简要总结
The patients will be randomized into either the Photobiomodulation with flap surgery (test group) or flap surgery alone (control group) using the computer-assisted randomization technique. Local anesthetic will be administered using 2% lignocaine hydrochloride with 1:80,000 adrenaline in the area to be operated. The surgical procedure will involve the elevation of a mucoperiosteal flap followed by debridement and root planing. In the test group, gallium/ aluminum/arsenide (GA-AL-AS) diode laser (Novolase, Trio-blue); 980nm laser will be used. 4J/cm2 dosage will be irradiated on buccal and lingual flaps before surgery and immediately post-operatively, 1-day post-op and 3-day post-op. Flap closure will be done by 3-0 black braided silk sutures.
Post–operative anti-inflammatory drugs will be prescribed to the patient.
Patient will be discharged after giving post-operative instructions.
Follow up will be done for clinical parameters after 7 days.
The postoperative pain assessment will be done through two methods: the number of capsules taken by the patient and visual analogue scale [no pain (0) to unbearable pain (10)]
Patient will be recalled after 7 days for suture removal.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy individuals Subjects of age 30 – 60 years.
- •Subjects with probing pocket depth of ≥ 5mm after phase I therapy.
- •Subjects willing to participate in the study.
排除标准
- •Pregnant women.
- •Subjects consuming tobacco in any form.
- •Patients with a history of long-term use of antibiotics and corticosteroids Subjects who underwent periodontal therapy in the past 6 months Previous or current radiation therapy.
结局指标
主要结局
Wound healing index (WHI)
时间窗: immediate post-operative, 3 days, 7 days
次要结局
- Pain assessment(1 to 7 days)
研究者
Akanksha A Gugale
KLE VK Institute of Dental Sciences