EdemaNCT06758258
Negative Pressure Wound Therapy in Oral Surgery
A study testing Negative Pressure Wound Therapy in people with Edema and Postoperative Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Edema, Postoperative Pain, Postoperative Complications
- What is being tested?
- Negative Pressure Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2024to 18 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years
- Undergone surgical extraction of a right or left impacted mandibular third molar
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University, Faculty of Dentistry
Tokat Province, 60100
About this study
Official title: Evaluating the Impact of Negative Pressure Wound Therapy on Inflammatory Symptom Severity Following Impacted Third Molar Extractions
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.
Read the 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
- Being tested
- Negative Pressure Wound Therapy, Sham Therapy
- Keywords
- Negative-Pressure Wound Therapy, Molar, Third
- Medical subject headings
- Edema, Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
Preparations for NPWT:
- Impressions \& Model: Lower jaw impressions were taken with alginate and modified trays for optimal tissue recording. Dental plaster models were created.
- 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 TherapyDevice
The same preparations will be conducted for the sham application arm, except that the peristaltic pump of the physiodispenser will remain inactive during application.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Sham Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative Seventh Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start18 Apr 2024
- Primary completion18 Oct 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aras Erdil, Tokat Gaziosmanpasa University
- Investigators
- Mehmet A Güngör, Prof Dr, Study chair, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758258
- Sponsor's protocol ID
- Usak-GOKA-500-500-05
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication of the study findings in a peer-reviewed journal, requests for data sharing will be considered by the responsible researcher.
Publications
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.
PubMed 38076307Laimer 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.
PubMed 28396234Mellott 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.
PubMed 29563472Erdil 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.
PubMed 41291693
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Negative Pressure Wound Therapy on Inflammatory Symptom Severity Following Impacted Third Molar Extractions
- ClinicalTrials.gov ID
- NCT06758258
- Acronym / sponsor ID
- Usak-GOKA-500-500-05
- Conditions
- Edema, Postoperative Pain, Postoperative Complications
- Keywords
- Negative-Pressure Wound Therapy, Molar, Third
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: Negative Pressure Wound TherapyFollowing 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 |
| Sham Therapy | Sham comparator | Device: Sham TherapyAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 to 65 years
- Undergone surgical extraction of a right or left impacted mandibular third molar
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound TherapyPreparations 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 | Negative Pressure Wound Therapy |
| Sham TherapyThe same preparations will be conducted for the sham application arm, except that the peristaltic pump of the physiodispenser will remain inactive during application. | Device | Sham Therapy |
Primary outcome
Preoperative Pain Intensity
Time frame: On the day of surgery preoperatively
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.
Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits
Time frame: Preoperatively on the day of surgery, postoperative second and seventh days.
All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
Change From Baseline Facial Measurements on Postoperative Follow Up Visits
Time frame: Preoperatively on the day of surgery, postoperative second and seventh days.
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.
Postoperative Pain Intensity-1
Time frame: Postoperative Second Day
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 Pain Intensity-2
Time frame: Postoperative Seventh Day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Background: PubMed 38076307Sternick 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.
- Background: PubMed 28396234Laimer 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.
- Background: PubMed 29563472Mellott 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.
- Derived from this study: PubMed 41291693Erdil 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.
- Individual participant dataSharing planned: Yes. Following publication of the study findings in a peer-reviewed journal, requests for data sharing will be considered by the responsible researcher.
Related trials for Edema
Active, not recruitingPhase 3
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
Diabetic Retinopathy, Macular Edema
Recruiting
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Acute Kidney Injury, Fluid Overload
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
Diabetic Macular Edema (DME)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet A Güngör, Prof Dr study chair
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy in people with Edema and Postoperative Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Pain Intensity (time frame: On the day of surgery preoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06758258, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.