Negative Pressure Wound Therapy in Oral Surgery

Not Applicable

Completed

• Conditions: Edema; Postoperative Pain; Postoperative Complications

• Registration Number: NCT06758258
• Lead Sponsor: Tokat Gaziosmanpasa University

Brief Summary

Inflammatory complications following the surgical removal of third molars remain a common and unavoidable challenge. These complications significantly impact patients' quality of life, prompting the development of numerous pharmacological and non-pharmacological interventions, as described in the current literature. However, non-interventional and non-pharmacological approaches remain a topic of debate.

Negative pressure wound therapy (NPWT) has demonstrated effectiveness in managing oral cavity wounds, such as orocutaneous and pharyngocutaneous fistulas, as well as drug-induced osteonecrosis. Despite its potential, no clinical studies with a systematic approach have evaluated its use in this context. Therefore, this study aims to assess the effectiveness of NPWT, a method with promising results in wound management, for reducing inflammatory complications following the extraction of impacted third molars, one of the most commonly performed oral surgical procedures.

Detailed Description

Impacted tooth surgeries are among the most frequently performed procedures in oral and maxillofacial surgery. These surgeries require intensive training, skill, and experience to minimize trauma during the procedure. Despite careful and atraumatic surgical techniques, complications such as pain, swelling, trismus, and bleeding often occur due to surgical trauma. While these postoperative complications are addressed through atraumatic approaches, their complete elimination remains unattainable. Consequently, numerous studies have been conducted to minimize postoperative inflammatory complications.

According to difficulty level parameters, surgical cases are categorized as uncomplicated, moderately difficult, and difficult. Expected physiological responses to surgical procedures, such as swelling, pain, mild bleeding, and muscle stiffness, may arise depending on these difficulty levels. However, even these expected complications can negatively impact the psychological well-being of patients and cause significant postoperative discomfort.

To alleviate such discomfort and facilitate a smoother recovery, pharmacological treatments, including non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, are commonly administered orally, intramuscularly, or submucosally before or after the procedure. Additionally, extraoral cold applications (e.g., ice packs) are recommended to reduce postoperative edema. However, the effectiveness of ice therapy remains controversial, and no universally accepted non-pharmacological treatment has yet been identified to mitigate expected postoperative inflammatory symptoms.

Negative Pressure Wound Therapy (NPWT) was first introduced in 1986. Its efficacy was demonstrated in an animal study by Morykwas et al. and subsequently in a clinical trial conducted by Argenta and Morykwas in 1997. These promising results led to the development of a systematic device marketed under the name Vacuum Assisted Closure (VAC) by Kinetic Concepts (KCI, San Antonio, TX, USA).

The beneficial effects of NPWT are thought to result from five primary mechanisms: macro tension, micro tension, fluid and edema removal, reduction of infective material, and wound stabilization. Given the inflammatory nature of complications following the surgical extraction of impacted third molars, NPWT is hypothesized to be effective in managing these issues. It is expected that NPWT may accelerate intraoral wound healing, reduce postoperative edema and bacterial load, and consequently improve patients' quality of life after surgery.

To date, there are no observational or interventional studies systematically examining the intraoral application of NPWT. However, some literature suggests its extraoral use in treating orocutaneous and pharyngocutaneous fistulas. Limited case reports have explored intraoral applications, such as in drug-induced jaw necrosis and the decompression of keratocystic lesions, showing promising outcomes.

This study aims to evaluate the effects of NPWT, a non-invasive and non-pharmacological technique, on inflammatory symptoms-pain, swelling, and restricted mouth opening-following the surgical extraction of impacted teeth. Furthermore, instead of employing commercially available NPWT devices, this study seeks to develop and validate a low-cost alternative using readily accessible materials. If successful, this approach could enable broader clinical use of NPWT by dentists and introduce a novel, cost-effective method to the existing literature.

Study Timeline

• Study Start: 2024-04-18
• Primary Completion: 2024-10-18
• Study Completion: 2024-11-18
• Status Verified: 2024-12
• Study First Submitted: 2024-12-26
• Study First Submitted QC: 2024-12-26
• Last Update Submitted: 2024-12-26
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Aged 18 to 65 years
• Undergone surgical extraction of a right or left impacted mandibular third molar

Exclusion Criteria

• Chronic Medical Conditions:

Patients with chronic diseases such as diabetes mellitus, chronic inflammatory diseases, chronic kidney or liver failure, chronic cardiovascular diseases, and autoimmune diseases.

• Immunocompromised Patients:

Immunosuppressed patients, including those diagnosed with malignancy.

• Allergies:

Patients with a history of allergy to any component of the NPWT treatment.

• Non-Adherence:

Patients who did not attend scheduled follow-up appointments within the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Preoperative Pain Intensity	On the day of surgery preoperatively	The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain on the day of surgery preoperatively.
Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits	Preoperatively on the day of surgery, postoperative second and seventh days.	All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
Change From Baseline Facial Measurements on Postoperative Follow Up Visits	Preoperatively on the day of surgery, postoperative second and seventh days.	Measurements were performed on the ipsilateral site between tragus and lateral commissura, lateral canthus and angle of mandible with a flexible ruler. The obtained values' average amounts were calculated and recorded for each patient.
Postoperative Pain Intensity-1	Postoperative Second Day	The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.
Postoperative Pain Intensity-2	Postoperative Seventh Day	The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.

Trial Locations

Locations (1)

Tokat Gaziosmanpasa University, Faculty of Dentistry; 🇹🇷 Tokat, Turkey