]>
IRCT20231213060357N2 IRCT 2025-04-11 Shiraz University of Medical Sciences Evaluation of Postsurgical Wound Healing, Pain and Complications of Plasma Pen-Assisted Surgery of Reactive Exophytic Oral Soft Tissue Lesions Evaluation of Postsurgical Wound Healing, Pain and Complications of Plasma Pen-Assisted Surgery of Reactive Exophytic Oral Soft Tissue Lesions Compared to Conventional Surgery: A Randomized Clinical Trial 2025-04-21 anticipated 30 Complete https://irct.ir/trial/82380 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation will be performed using a computer random number generator. For example, a random number (e.g., ۰ or ۱) will be generated. If the random number is ۰, the participant will be assigned to the control group ; if the random number is ۱, the participant will be assigned to the intervention group. N/A Reactive Exophytic Oral Soft Tissue Lesions. Intervention 1: Intervention group: After baseline examination and obtaining an informed consent, the lesions will be completely excised under local anesthesia using ۲% lidocaine with ۱:۱۰,۰۰۰ epinephrine using a plasma pen under perfectly aseptic conditions. Excision will be performed according to the standard oral surgical procedures. After retracting the basal part of the lesion superiorly using a clamp, excision will be performed such that the borders were in the intact tissue. It is important to note that the wounds occurred after the excisions with plasma pen will be allowed for secondary healing. Intervention 2: Control group: After baseline examination and obtaining an informed consent, the lesions will be completely excised under local anesthesia using ۲% lidocaine with ۱:۱۰,۰۰۰ epinephrine using a surgical blade under perfectly aseptic conditions. Excision will be performed according to the standard oral surgical procedures. After retracting the basal part of the lesion superiorly using a clamp, excision will be performed such that the borders were in the intact tissue.The incision will be closed by suture after bleeding has been controlled. Yes - There is a plan to make this available What will be shared: Data can be shared after de-identifying individuals. When: Data will be available up to 6 months after publication. To whom: The researchers in academic and scientific institutions Conditions: Data will be available after the trial is completed and results are published. This data can be used for research or educational purposes upon request, with a clear description of the intended use, and subject to approval by the study team and adherence to ethical research standards. Where to obtain: The data supporting the findings of this study will be available upon reasonable request from the corresponding author. How to obtain: The researchers in academic and scientific institutions can email the corresponding author and request for information. Comments:
public Asma Sookhakian
Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3628 0112 asma.soukhakian@gmail.com Shiraz University of Medical Sciences scientific Maryam Zahed
Shiraz School of Dentistry, Ghasrodasht street
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3628 0112 maryamzhd@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) subjects (both males and females) aged ۱۸ years or older Subjects diagnosed with reactive exophytic oral soft tissue lesions (less than one centimeter) on the buccal mucosa based on the clinical findings Subjects who are willing to participate and complete this study 18 years no limit Both Any subject diagnosed clinically with possible neoplastic changes such as rapid growth pattern and induration Any subject diagnosed with systemic diseases that could interfere with wound healing such as diabetes D10 Benign neoplasm of mouth and pharynx Treatment - Surgery Treatment - Surgery Intervention group: After baseline examination and obtaining an informed consent, the lesions will be completely excised under local anesthesia using ۲% lidocaine with ۱:۱۰,۰۰۰ epinephrine using a plasma pen under perfectly aseptic conditions. Excision will be performed according to the standard oral surgical procedures. After retracting the basal part of the lesion superiorly using a clamp, excision will be performed such that the borders were in the intact tissue. It is important to note that the wounds occurred after the excisions with plasma pen will be allowed for secondary healing. Control group: After baseline examination and obtaining an informed consent, the lesions will be completely excised under local anesthesia using ۲% lidocaine with ۱:۱۰,۰۰۰ epinephrine using a surgical blade under perfectly aseptic conditions. Excision will be performed according to the standard oral surgical procedures. After retracting the basal part of the lesion superiorly using a clamp, excision will be performed such that the borders were in the intact tissue.The incision will be closed by suture after bleeding has been controlled. Pain Level. Timepoint: 24 hours after the surgery, and again after 2, 3, 4, 5, 6, and 7 days. Method of measurement: Visual Analogue Scale. Wound Healing. Timepoint: On days 7, 14, 28, and 84 after surgery. Method of measurement: Wound healing index described by Landry et al, which evaluate parameters such as presence of bleeding, supporation, granulation tissue, tissue color, and epithelialization. Complications. Timepoint: On days 7, 14, 28, and 84 after surgery. Method of measurement: Visual inspection to examine the surgery site for any visible changes such as redness, swelling, discoloration, scar, or recurrence, and palpation to assess for any palpable abnormalities. Shiraz University of Medical Sciences Approved 2025-02-26 Research Ethics Committee of School of Dentistry-Shiraz University of Medical Sciences Shiraz University of Medical Science, Zand street Shiraz Fars Iran (Islamic Republic of)