Evaluation of the Effect of Different Biomaterials on Palatal Wound Healing. A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Wound healing assessment
研究概览
简要总结
All study subjects will sign written informal consent form before enrolment.
They will be divided into four groups, 10 patients each:
- Group I: Palatal wound will be left to heal spontaneously,
- Group II: Palatal wound will be covered with Composite stent,
- Group III: Palatal wound will be covered with PRF,
- Group IV: Palatal wound will be covered with Ora-aid patch. III- Surgical Procedures: -
- After harvesting the palatal soft tissue graft with the standardized dimensions (12 × 7 mm) of the graft for all patients. Graft thickness was standardized as well to be approximately 1.5 to 2 mm and confirmed with a caliper at 3 points (ends and centre of the graft). Fixing of the graft at the recipient site will be performed, back to the donor site for management, the blood clot will be wiped with gauze, then placement of different materials according to each group.
- The dressing will be then pressed gently for 10 seconds, to aid its adherence to the wound. Fixation of the patch will be followed, using 5/0 propylene suture, with performing sling horizontal figure eight suture technique.
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are indicated for soft tissue augmentation procedures, either with root coverage or to increase the deficient keratinized tissue,
- •Medically free patients,
- •Non-smokers and
- •Patients with good oral hygiene.
排除标准
- •Pregnant or lactating females,
- •Patients with untreated periodontal condition and
- •Patients with uncontrolled systemic condition.
研究组 & 干预措施
control group
Palatal wound will be left to heal spontaneously
study group 1
Palatal wound will be covered with Composite stent
干预措施: Palatal wound will be covered with Composite stent (Device)
study group 2
Palatal wound will be covered with PRF
干预措施: Palatal wound will be covered with PRF (Combination Product)
study group 3
Palatal wound will be covered with Ora-aid patch
干预措施: Palatal wound will be covered with Ora-aid patch (Device)
结局指标
主要结局
Wound healing assessment
时间窗: From enrollment to the end of treatment at 4 weeks
The parameters of tissue color, bleeding response to palpation, presence of granulation tissue, characteristics of the incision margins, and the presence of suppuration were evaluated as this index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing gets a score of 5.
Pain using the visual analogue scale
时间窗: From enrollment to the end of treatment at 4 weeks
Patients were asked about their pain levels, swelling, and other experiences related to the surgical techniques and instruments to assess postoperative pain. The perceived discomfort was rated using a VAS, which is marked at two endpoints: "no discomfort" at one end (score of 0) and "unbearable discomfort" at the other end (score of 10). Patients completed the questionnaires on the 1st, 2nd, 4th, 7th, and 14th days after their surgery
次要结局
- Patient satisfaction through direct communication(From enrollment to the end of treatment at 4 weeks)
研究者
Fatma saad saad mahmoud elsherbini
PhD, Lecturer, Oral Medicine, Periodontology, Diagnosis, and Oral Radiology Department,
Mansoura University