Negative Pressure Wound Therapy in Oral Surgery

NCT ID: NCT06758258

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-18
• Study Completion Date: 2024-11-18

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.

Conditions

Edema; Postoperative Pain; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Negative Pressure Wound Therapy

Following third molar extraction, patients receive custom-fit, transparent splints fabricated from thermoformed acrylic resin. Splints are assessed for fit, adaptation, and leak-proof integrity.

Holes are created in the splints at the surgical site and connected to a physiodispenser irrigation hose using cyanoacrylate adhesive.

The splint is positioned intraorally, and the physiodispenser pump is operated in reverse to generate negative pressure.

Personalized negative pressure therapy is applied for three hours, with one-hour sessions

Group Type: EXPERIMENTAL

Negative Pressure Wound Therapy

Intervention Type: DEVICE

Preparations for NPWT:

1. Impressions & Model:

Lower jaw impressions were taken with alginate and modified trays for optimal tissue recording.

Dental plaster models were created.

2. Splint Fabrication & Connection:

2mm hard splints were thermoformed and modified for vacuum. Intraoral splint fit was assessed, and soft acrylic ensured an airtight seal. The irrigation hose was connected to the splint via cyanoacrylate adhesive. 3. NPWT Application: The physiodispenser pump was operated in reverse at reduced power (10-20%). Three 1-hour NPWT sessions were performed.

Sham Therapy

All surgical and prosthetic interventions planned for the negative pressure wound therapy (NPWT) arm will be conducted. However, for patients in this arm, while personalized appliances will be placed intraorally, the peristaltic pump of the physiodispenser will remain inactive. The duration (1 hour) and intervals (day of surgery, first and third postoperative days) of appliance application will mirror those of the active NPWT arm.

Group Type: SHAM_COMPARATOR

Sham Therapy

Intervention Type: DEVICE

The same preparations will be conducted for the sham application arm, except that the peristaltic pump of the physiodispenser will remain inactive during application.

Interventions

Negative Pressure Wound Therapy

Preparations for NPWT:

1. Impressions & Model:

Lower jaw impressions were taken with alginate and modified trays for optimal tissue recording.

Dental plaster models were created.

2. Splint Fabrication & Connection:

2mm hard splints were thermoformed and modified for vacuum. Intraoral splint fit was assessed, and soft acrylic ensured an airtight seal. The irrigation hose was connected to the splint via cyanoacrylate adhesive. 3. NPWT Application: The physiodispenser pump was operated in reverse at reduced power (10-20%). Three 1-hour NPWT sessions were performed.

Intervention Type: DEVICE

Sham Therapy

The same preparations will be conducted for the sham application arm, except that the peristaltic pump of the physiodispenser will remain inactive during application.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tokat Gaziosmanpasa University

OTHER

Sponsor Role: lead

Responsible Party

Aras Erdil

Assist. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet A Güngör, Prof Dr

Role: STUDY_CHAIR

Uşak University

Locations

Tokat Gaziosmanpasa University, Faculty of Dentistry

Tokat Province, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 38076307 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28396234 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29563472 (View on PubMed)

Other Identifiers

Usak-GOKA-500-500-05

Identifier Type: -

Identifier Source: org_study_id