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Effect of Cold Atmospheric Pressure Plasma on Orthognathic Surgery Wound Healing: A randomized controlled clinical trial

Effect of Cold Atmospheric Pressure Plasma on Orthognathic Surgery Wound Healing: A randomized controlled clinical trial

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230606004
Enrollment
60
Registered
2023-06-06
Start date
2023-06-29
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Participants in intervention A group will receive cold plasma application on 24 hours of surgery. Duration is 20 mins, in the morning 7.30 am. Application is intraorally, on the surgical wound and it
Experimental Device,Experimental Device,Experimental Device,Experimental Device,No Intervention Device
Intervention A group,Intervention B group,Intervention C group,Intervention D group,Control group

Sponsors

Chulalongkorn University
Lead Sponsor
Mirari Thailand
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Patient's satisfaction assessment Postoperative day 14 Satisfaction questionnaires,Microbial accumulation assessment Postoperative day 1, 2, 3, 14 Bacterial colonization by CFU

Countries

Thailand

Contacts

Public ContactBoosana Kaboosaya

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand

boosana.k@chula.ac.th0625644295

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026