Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT06758258
Status:
COMPLETED
Last Update Posted:
2025-01-03
First Post:
2024-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Negative Pressure Wound Therapy in Oral Surgery
Sponsor:
Tokat Gaziosmanpasa University
Organization:
Study Overview
Official Title:
Evaluating the Impact of Negative Pressure Wound Therapy on Inflammatory Symptom Severity Following Impacted Third Molar Extractions
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: