Effect of Ozonized Gel Compared to Photobiomodulation Therapy on Wound Healing Following Surgical Gingivectomy : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Healing index (HI) using Landry index
研究概览
简要总结
The goal of this clinical trial is to compare the effect of photobiomodulation to ozonized gel on wound healing following gingivectomy procedure on adults. The main questions it aims to answer are:
Which treatment modality provides less painful and more efficient wound healing ? What are the patient's feedback on different treatment modalities ? Researchers will compare ozonized gel to photobiomodulation to normal gingivectomy procedure with no interference.
Participants will:
Receive either ozonized gel or photobiomodualtion treatment following surgical gingivectomy Visit the clinic every 3,7,14 and 28 days for checkups and investigations
详细描述
Surgical gingivectomy is performed for elimination of supra bony pockets and gingival enlargements and it can be considered the gold standard treatment for such cases. The healing of wound site after gingivectomy occurs slowly by secondary intention; therefore, several studies have been conducted evaluating the effect of various treatment modalities to accelerate the process of wound healing such as use of ozonized gel and photobiomodulation. Ozone, owing to its biocompatibility, healing, and antimicrobial properties, is used for wound healing and tissue repair. Photobiomodulation Therapy (PBMT) using diode laser is another treatment modality regarded as an effective modality for the repair of tissues, control of pain and wound healing. This study will be carried out to clinically compare and evaluate the healing of surgical gingivectomy wounds using ozonized gel and PBMT.
Aim: Compare the efficacy of the ozonized gel to photobiomodulation therapy in wound healing following surgical gingivectomy Materials and Methods: This randomized controlled clinical trial will involve 48 surgical gingivectomy wound sites, equally divided into three groups, Group-I (test group1): ozonized hydrogel will be applied to raw wound area following surgical gingivectomy and at days 3,7,14 post surgery. Group II (test group 2): the surgical site will be irradiated with a diode laser (635 nm) directly following surgery and at days 3,7,14 postoperative. Group III (control group) will include surgical gingivectomies that will be left to heal spontaneously. Wound healing will be assessed using Landry's Healing index and by measuring degree of epithelialization, and pain level will be assessed using a Visual analog scale on the 3rd, 7th, 14th, and 28th days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients indicated for surgical gingivectomy.
- •Adequate amount of keratinized tissue.
- •Average age between 18-40 years.
- •Well-educated patients as post-operative instructions need to be followed precisely.
- •Good oral hygiene with a full mouth O'Leary plaque index of less than or equal to 10% and a full mouth Gingival Index of zero
排除标准
- •History of smoking.
- •Patients who have any known systemic disease that interfere with performance of surgical gingivectomy or periodontal wound healing.
- •Patients who have any previous adverse reactions to the products (or similar products) used in this study.
- •Pregnant women.
研究组 & 干预措施
Control group
Spontaneous healing of wound area following surgical gingivectomy
Ozonized gel group
Application of ozonized gel to raw wound area following surgical gingivectomy.
干预措施: ozonized gel application (Drug)
Photobiomodulation therapy group
Application of diode laser 635nm to wound area following surgical gingivectomy
干预措施: photobiomodulation therapy using diode laser (Device)
结局指标
主要结局
Healing index (HI) using Landry index
时间窗: day 3,7,14,28 post surgical gingivectomy
The healing index (HI) scores will be assessed on the basis of redness, presence of granulation tissues, bleeding, suppuration, and epithelialization.
Evaluation of epithelialization of the wound area
时间窗: days 0,3,7,14,28 post surgical gingivectomy
A plaque disclosing agent is used to measure wound area epithelialization by dying the abraded and deepithelialized areas on the gingiva on postoperative days 3,7,14 and 28. By using this solution, assessment of degree of epithelialization and wound healing is made easier. Wound surface epithelialization in the obtaining photographs will be evaluated using an Image-analyzing software. To ensure standardization, all photographs will taken by the same person with the same camera at the same angle.
Postoperative pain using the VAS
时间窗: day 0. day 3, day 7, and day 14 post surgery.
Visual Analogue Scale (VAS) is a simple measurement tool that measures the intensity of pain as recorded by the patient. 10-point visual analog scale of pain rating, with 0 marked as "no pain" and 10 marked as "worst pain imaginable
Healing index (HI) using Landry index
时间窗: day 3,7,14,28 post surgical gingivectomy
The healing index (HI) scores will be assessed on the basis of redness, presence of granulation tissues, bleeding, suppuration, and epithelialization.
Evaluation of epithelialization of the wound area
时间窗: days 0,3,7,14,28 post surgical gingivectomy
A plaque disclosing agent is used to measure wound area epithelialization by dying the abraded and deepithelialized areas on the gingiva on postoperative days 3,7,14 and 28. By using this solution, assessment of degree of epithelialization and wound healing is made easier. Wound surface epithelialization in the obtaining photographs will be evaluated using an Image-analyzing software. To ensure standardization, all photographs will taken by the same person with the same camera at the same angle.
次要结局
- Gingival crevicular fluid sampling for Vascular Endothelial Growth Factor quantification(baseline(day 0), day 7,day14 and day 28 post gingivectomy)
研究者
Mennatullah osama ahmed zaki wahba
Dentist
Alexandria University