Clinical trial NCT06758258: Negative Pressure Wound Therapy in Oral Surgery
Official title: Evaluating the Impact of Negative Pressure Wound Therapy on Inflammatory Symptom Severity Following Impacted Third Molar Extractions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema
Postoperative Pain
Postoperative Complications
Keywords: Negative-Pressure Wound Therapy
Molar, Third
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as a randomized controlled parallel-group model. The required sample size will be equally divided into two groups: the study group and the control group. Participants in the study group will receive the targeted therapy, while those in the control group will receive sham appliances under identical conditions.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preoperative Pain Intensity
timeFrame: On the day of surgery preoperatively
measure: Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits
timeFrame: Preoperatively on the day of surgery, postoperative second and seventh days.
measure: Change From Baseline Facial Measurements on Postoperative Follow Up Visits
timeFrame: Preoperatively on the day of surgery, postoperative second and seventh days.
measure: Postoperative Pain Intensity-1
timeFrame: Postoperative Second Day
measure: Postoperative Pain Intensity-2
timeFrame: Postoperative Seventh Day
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University, Faculty of Dentistry
Study officials:
affiliation: Uşak University
name: Mehmet A Güngör, Prof Dr
role: STUDY_CHAIR
References:
citation: Sternick M, Gates JC, Champion A, Yampolsky A. Negative pressure wound therapy for complex oral wounds. J Surg Case Rep. 2023 Dec 6;2023(12):rjad638. doi: 10.1093/jscr/rjad638. eCollection 2023 Dec.
citation: Laimer J, Steinmassl O, Hechenberger M, Rasse M, Pikula R, Bruckmoser E. Intraoral Vacuum-Assisted Closure Therapy-A Pilot Study in Medication-Related Osteonecrosis of the Jaw. J Oral Maxillofac Surg. 2017 Oct;75(10):2154-2161. doi: 10.1016/j.joms.2017.02.033. Epub 2017 Mar 18.
citation: Mellott AJ, Zamierowski DS, Andrews BT. Negative Pressure Wound Therapy in Maxillofacial Applications. Dent J (Basel). 2016 Sep 6;4(3):30. doi: 10.3390/dj4030030.