Effects of StellaLife Oral Care Recovery Kit on Palatal Wound Healing After Free Gingival Graft
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Wound Healing Estimation
研究概览
简要总结
This study looks to compare the clinical effects of StellaLife VEGA Oral Care Kit with chlorhexidine mouth-rinse on patient comfort, wound healing, wound epithelialization, bacterial levels, and colonization of the wounds.
详细描述
A total of 60 participants will be recruited from those needing and have been treatment planned for a free gingival graft surgery to increase keratinized gum. The study subjects will be randomly allocated to either negative control group (NC), chlorhexidine group (C) or StellaLife group (S) by randomization done using a computer-generated table.
The NC group is provided normal saline mouth-rinse to rinse 2 times per day along with placebo gel to be applied 2 times and placebo oral spray. The S group will use StellaLife Oral Care mouth-rinse, gel and spray 2 times per day. The C group will use chlorhexidine mouth-rinse and placebo gel and spray 2 times per day. All groups beginning the same day and continuing for the duration of two weeks. All patients will receive a protective splint. Following this, subjective and objective measurements on the success of the mouthwash and oral care kit will be measured.
Patients will be evaluated post operatively following surgery as mentioned below:
- Wound Healing Assessment and Epithelization Assessment: Postoperative Days 1, 5, 14, 21 and 28
- Oral Health Impact Profile-14 and Functional Pain Scale: Starting on the day of the surgery and Postoperative Days 1, 5, 14, 21 and 28
- Wound Exudate assessment: Samples collected on Postoperative Days 1, 5, 14, 21 and 28
- Wound Plaque assessment: Starting on the day of the surgery and Postoperative Days 1, 5, 14, 21 and 28
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The participants will be masked to which mouth-rinse, gel and spray they are receiving.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥18 years,
- •No history of medication affecting periodontal status in the last 6 months,
- •No history of allergy to study medication or material,
- •No use of tobacco,
- •No history of pregnancy or lactation or contraceptive medication
- •Good oral hygiene.
排除标准
- •Previous palatal surgery
- •Patient on anticoagulant therapy
- •Uncontrolled diabetes,
- •Rheumatoid arthritis,
- •Osteoporosis.
结局指标
主要结局
Wound Healing Estimation
时间窗: Samples collected on Postoperative days: day 1, day 5, day 14, day 21 and day 28
Clinical photographs of the donor site will be taken at baseline, immediately after surgery, and at each follow-up visit, to record the appearance A sterile paper measuring tape in millimeters will be placed on the length and width of the wound at the time getting the picture, then with use of the image analysis software the size (area in sq millimeter) and wound healing estimation will be made. The images will be analyzed with ImageJ software to determine area.
次要结局
- Oral Health Impact Profile-14(Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28)
- Epithelization Assessment(Samples collected on Postoperative days: day 1, day 5, day 14, day 21 and day 28)
- Wound Exudate assessment(Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28)
- Wound Plaque assessment(Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28)
- Functional Pain Scale(Starting on the day of the surgery and Postoperative Days: day 1, day 5, day 14, day 21 and day 28)