Negative Pressure Wound Therapy in Oral Surgery

NCT06758258 | Completed

• 1 other identifier: Usak-GOKA-500-500-05
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Edema; Postoperative Pain; Postoperative Complications

Keywords

Negative-Pressure Wound Therapy; Molar, Third

Outcome Measures

Primary Outcomes (5)

• Preoperative Pain Intensity

  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.

  On the day of surgery preoperatively

• Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits

  All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.

  Preoperatively on the day of surgery, postoperative second and seventh days.

• Change From Baseline Facial Measurements on Postoperative Follow Up Visits

  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.

  Preoperatively on the day of surgery, postoperative second and seventh days.

• Postoperative Pain Intensity-1

  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 Second Day

• Postoperative Pain Intensity-2

  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 Seventh Day

Study Arms (2)

Negative Pressure Wound Therapy

EXPERIMENTAL

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

Device: Negative Pressure Wound Therapy

Sham Therapy

SHAM COMPARATOR

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.

Device: Sham Therapy

Interventions

Negative Pressure Wound Therapy 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.

Negative Pressure Wound Therapy

Sham Therapy 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.

Sham Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University, Faculty of Dentistry

Tokat Province, 60100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 38076307 BACKGROUND

• 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.

  PMID: 28396234 BACKGROUND

• 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.

  PMID: 29563472 BACKGROUND

• Erdil A, Celikkol O, Caymaz A, Son A. Effectiveness of topical vacuum assisted drainage in mandibular third molar surgeries: a randomized controlled clinical study. BMC Oral Health. 2025 Nov 25;25(1):1838. doi: 10.1186/s12903-025-07243-0.

  PMID: 41291693 DERIVED

MeSH Terms

Conditions

Edema; Pain, Postoperative; Postoperative Complications

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Mehmet A Güngör, Prof Dr

  Uşak University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The enrolled participants will be recorded anonymously, with each assigned a unique identification number. These numbers will then be randomized into two study groups using free online randomization software. As a result, both the researcher and the participants will remain blinded to the assigned study groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: April 18, 2024
• Primary Completion: October 18, 2024
• Study Completion: November 18, 2024
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon publication of the study results
• Access Criteria: Reasonable requests

Locations

TU (1)