Effect of Cold Atmospheric Pressure Plasma on Orthognathic Surgery Wound Healing: A randomized controlled clinical trial
- Conditions
- Healthy male and female participants between 20 and 35 years old who are planning to take orthognathic surgeries using bilateral sagittal split ramus osteotomy technique with rigid osteofixation will be included in this study. Postoperative wound healing and microbial accumulation around the wound will be studied.Orthognathic surgery, wound healing, microbial colony counts, non-thermal atmospheric pressure plasma
- Registration Number
- TCTR20230606004
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 60
1. Systematically healthy patient (ASA I)
2. Adult (20-35 years old) male or female
3. Patient with norma gingival health (Gingival index 0) preoperatively
4. Patient planned for orthognathic surgeries with bilateral sagittal split ramus osteotomies
5. Patient who agree to participate in research after explaining detail
1.Smoking or chronic alcoholic patient
2.Pregnant or lactating mother
3.Patients with systemic diseases such as uncontrolled diabetes mellitus, HIV, cancer, thyroid disease, immunocompromised host including HIV
4.Patients with hereditary healing disorders
5.Patients with long-term corticosteroids or immunosuppressive agents
6.Patient with a history of chemotherapy or radiotherapy
7.Patients with a previous history of oral surgery within 2 months
8.Patient with a plan for additional surgeries at the same time such as genioplasty or Lefort I osteotomies
9.Any errors such as bad split happened during their orthognathic surgery
10.Operative time more than 4 hours (since the first incision until the last suturing)
11.Patients show any allergies or feel uncomfortable with Cold Atmospheric Pressure Plasma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound healing assessment Postoperative day 1 Early wound healing score (EHS),Wound healing assessment Postoperative day 14 Wound healing index (WHI),Wound Healing assessment Postoperative day 14 Wound epithelialization assessment
- Secondary Outcome Measures
Name Time Method Patient's satisfaction assessment Postoperative day 14 Satisfaction questionnaires,Microbial accumulation assessment Postoperative day 1, 2, 3, 14 Bacterial colonization by CF