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Negative Pressure Wound Therapy in Oral Surgery

NCT06758258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-01-03

No results posted yet for this study

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Tokat Gaziosmanpasa University

    lead OTHER

Principal Investigators

  • Mehmet A Güngör, Prof Dr · Uşak University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-18
Primary Completion
2024-10-18
Completion
2024-11-18

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06758258 on ClinicalTrials.gov