Postoperative Edema and PainPEMFNCT02376946
Third Molar Extraction and Pulsed Electromagnetic FieldTherapy
A study testing ActiPatch(TM) in people with Postoperative Edema and Pain, run by Tufts University at 1 site in United States.
Trial summary
This study is a prospective, randomized, double-blinded, controlled, clinical trial that evaluates the efficacy of using PEMF in the postoperative period in decreasing swelling and pain after extraction of impacted third molars. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Edema and Pain
- What is being tested?
- ActiPatch(TM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects of either sex and of any race between the ages of 18 and 30 years. 30 Years old is the upper age limit because wisdom teeth extraction is normally done between the ages of 18 and 30, since after the age of 30 additional complications can arise during surgeries.
- Subjects for whom a decision has been made to extract 2 to 4 third molars. At least two must be classified as full or partially bony impacted (as defined below) of any angulation under local anesthesia alone, local anesthesia and sedation or local anesthesia and general anesthesia all in an outpatient setting.
- Full/complete bony: The entire tooth is below the level of the alveolar bone. The tooth is completely encased in bone so that when the gingiva is cut and reflected back, the tooth is not seen. Bone removal (large amounts) together with root sectioning will be needed to remove the tooth.33
- Partial bony: A portion of the height of the contour of the tooth is below the level of the alveolar bone. The superficial portion of the tooth is covered only by soft tissue but the height of the tooth's contour is below the level of the surrounding alveolar bone.33
- Subjects must be physically able to tolerate conventional surgical procedures (ASA I/II)
- Subjects must agree to follow the study protocol.
Who cannot join
- Subjects who are known to be pregnant or think they may be pregnant. (A urine pregnancy test will be performed on female subjects at Day 0 - Visit 1. Subjects testing positive will be excluded from study participation.
- Subjects with a cardiac pacemaker, cardioverter defibrillator, neurostimulator or any active medical or metallic implant (including dental implant).
- Subjects with skeletal immaturity.
- Subjects with self-reported current or history of substance abuse.
- Subjects who are currently receiving any anti-inflammatory or pain medication chronically or they suffer from a chronic pain condition.
- Subjects with an allergy to vicodin (or its constituents, acetaminophen and hydrocodone).
- Subjects who are diagnosed with fibromyalgia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine Department of Oral and Maxillofacial Surgery
Boston, Massachusetts, 02111
About this study
Official title: Evaluation of Postoperative Edema and Pain Following Third Molar Extraction With Application of Pulsed Electromagnetic Field (PEMF) Therapy
This study is a prospective, randomized, double-blinded, controlled, clinical trial that evaluates the efficacy of using PEMF in the postoperative period in decreasing swelling and pain after extraction of impacted third molars. The study group will be comprised of subjects that will receive PEMF Actiband treatment for postoperative management of pain and edema. The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema.
Thirty (30) subjects will be randomly assigned to each group. Enrollment will continue until 60 qualified subjects have been recruited. Eligibility criteria will be based on the standards for conducting oral surgery procedures on third molar extractions, in addition to safety considerations and contraindications for the Actiband and other agents to be used. Moreover, the selected subjects will have the same surgical difficulty and surgical trauma anticipated standardized by classification system of impacted third molars. All inclusion and exclusion criteria will be thoroughly explained in the relevant section of this proposal. Postoperative edema and pain will be evaluated using 3dMD and Visual Analog Scale, respectively. Different measurements will be obtained immediately before the surgery and in standard periodic intervals as described in the Materials and Methods section of the proposal. Any difference in postoperative edema, pain, and site responsible for request of rescue pain medication will be compared and analyzed between the two groups.
Read the detailed description
This study is a prospective, randomized, double-blinded, controlled, clinical trial that evaluates the efficacy of using PEMF in the postoperative period in decreasing swelling and pain after extraction of partial or full/complete boney impacted third molars. The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema. The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema.
Thirty (30) subjects will be randomly assigned to each group. Enrollment will continue until sixty (60) qualified subjects have been recruited. Eligibility criteria will be based on the standards for conducting oral surgery procedures on third molar extractions, in addition to safety considerations and contraindications for the ActiPatch(TM) and other agents to be used. Moreover, the selected subjects will have the same surgical difficulty and surgical trauma anticipated standardized by classification system of impacted third molars. This classification system is utilized in the TUSDM (Tufts University School of Dental Medicine) oral surgery clinic. All inclusion and exclusion criteria will be thoroughly explained in the relevant section of this proposal. Postoperative edema and pain will be evaluated using 3dMD(TM) and Visual Analog Scale, respectively. Different measurements will be obtained immediately before the surgery and in standard periodic intervals as described in the Materials and Methods section of the proposal. Any difference in postoperative edema, pain, and site responsible for request of rescue pain medication will be compared and analyzed between the two groups.
Up to 200 subjects will be enrolled in the study to account for screen failures. Up to forty (40) subjects will be randomly assigned to each group. Recruitment will continue until up to eighty (80) subjects have qualified for study participation. This will allow for up to 25% dropout to end with 60 subjects completing the study.
The primary outcome, postoperative facial swelling at 72 hours (as measured by the 3dMD(TM)), will be compared between the two groups using independent sample t-test if the data are normally distributed, or the Mann Whitney U test if non-parametric methods need to be utilized. This approach will also be utilized for comparing pain (as measured by VAS). The percentage of subjects who will use rescue pain medication due to experience of postoperative pain on the group treated with PEMF ActiPatch(TM) will be compared with the percentage of subjects who will use rescue pain medication due to experience of postoperative pain for the group received placebo, using a Chi-square test. In addition, the volume measurements and the VAS scores will be analyzed using a repeated measures analysis, adjusting for subject age, gender and pain perception. Furthermore, a correlation between placebo group and the use of rescue pain medication will be determined and the association will be dictated by calculating the odds ratio. The statistical significance of this association will be examined using the Chi-square test. All p-values less than 0.025 will be considered statistically significant. Statistical analyses will be performed using SAS, Version 9.2 (SAS Institute, Cary, NC).
An initial 3dMD(TM) scan will be obtained for baseline evaluation at the extraction visit. A second 3dMD(TM) scan will be obtained for evaluation and determination of facial swelling at the 72 hour follow up visit. A third scan will be obtained at the 10 day follow up visit to evaluate the degree of resolution of swelling. The scan will result in a computer-generated image, on which the investigator will outline the area of clinical interest and calculate the volume using integration. The process of surface scanning and volume measurement will use the 3dMD(TM) Vultus software® (3dMD(TM), Atlanta, Georgia, United States).The Vultus software allows for pre and post-surgery superimposition of images as well as quantitative evaluation of surface and volume changes. The PI has had on site training at the Georgia 3dMD facility and had additional training when the camera array was installed. The technique of obtaining the image is straight forward and there is a set of instructions at the installation site for immediate review as necessary. The PI and a representative from 3dMD company will give training to the co-investigators who will be using the device.
The degree of facial swelling between the two groups at the two time points (72 hour follow up and 10 day follow up) will be compared using the data collected from 3dMD(TM). Furthermore, the change in volume between the two scans taken at the 72 hour follow up visit and the 10 day follow up within each group will also be compared. The volumetric difference between the two groups will be analyzed for any statistical significance.
- Conditions
- Postoperative Edema and Pain
- Being tested
- ActiPatch(TM), Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiPatch(TM)Device
Also called ActiBand(TM)
Assigned by randomization, this study group will be comprised of subjects that receive the PEMF ActiPatch(TM) treatment for postoperative management of pain and edema.
PlaceboDevice
Assigned by randomization, this control group will be comprised of the subjects that receive a placebo patch as treatment for postoperative management of pain and edema.
| Study group | Role | What they receive |
|---|---|---|
| Actipatch | Active comparator | The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema. Receives: Device: ActiPatch(TM) |
| Placebo | Placebo comparator | The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postoperative Facial Swelling
The primary outcome, postoperative facial swelling at 72 hours (as measured by the 3dMDTM), will be compared between the two groups using independent sample t-test if the data are normally distributed, or the Mann Whitney U test if non-parametric methods need to be utilized.
Measured: 72 Hours post surgery and 10 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative Edema and PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- BioElectronics Corporation
- Responsible party
- Principal investigator, Archana Viswanath, Tufts University
- Investigators
- Archana Viswanath, Principal investigator, Research Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376946
- Sponsor's protocol ID
- 10436
- Acronym
- PEMF
- Status last verified
- Oct 2021
- First submitted
- 18 Feb 2015
- Last updated
- 1 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Little RC, Ginsburg JM. The physiologic basis for clinical edema. Arch Intern Med. 1984 Aug;144(8):1661-4. doi: 10.1001/archinte.144.8.1661.
PubMed 6466021Conrad SM, Blakey GH, Shugars DA, Marciani RD, Phillips C, White RP Jr. Patients' perception of recovery after third molar surgery. J Oral Maxillofac Surg. 1999 Nov;57(11):1288-94; discussion 1295-6. doi: 10.1016/s0278-2391(99)90861-3.
PubMed 10555792van Gool AV, Ten Bosch JJ, Boering G. Clinical consequences of complaints and complications after removal of the mandibular third molar. Int J Oral Surg. 1977 Feb;6(1):29-37. doi: 10.1016/s0300-9785(77)80069-0.
PubMed 402320Zuniga JR, Phillips CL, Shugars D, Lyon JA, Peroutka SJ, Swarbrick J, Bon C. Analgesic safety and efficacy of diclofenac sodium softgels on postoperative third molar extraction pain. J Oral Maxillofac Surg. 2004 Jul;62(7):806-15. doi: 10.1016/j.joms.2003.12.019.
PubMed 15218558Urquhart E. Analgesic agents and strategies in the dental pain model. J Dent. 1994 Dec;22(6):336-41. doi: 10.1016/0300-5712(94)90084-1.
PubMed 7844260Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002 Jul;133(7):861-71. doi: 10.14219/jada.archive.2002.0300.
PubMed 12148679Troullos ES, Hargreaves KM, Butler DP, Dionne RA. Comparison of nonsteroidal anti-inflammatory drugs, ibuprofen and flurbiprofen, with methylprednisolone and placebo for acute pain, swelling, and trismus. J Oral Maxillofac Surg. 1990 Sep;48(9):945-52. doi: 10.1016/0278-2391(90)90007-o.
PubMed 2395047Schultze-Mosgau S, Schmelzeisen R, Frolich JC, Schmele H. Use of ibuprofen and methylprednisolone for the prevention of pain and swelling after removal of impacted third molars. J Oral Maxillofac Surg. 1995 Jan;53(1):2-7; discussion 7-8. doi: 10.1016/0278-2391(95)90486-7.
PubMed 7799116Ganzber S. Analgesics: opioids and nonopioids. In: Ciancio S, ed. ADA guide to dental therapeutics. Chicago: ADA Publishing; 1998:80-107.
Dionne RA, Gordon SM. Nonsteroidal anti-inflammatory drugs for acute pain control. Dent Clin North Am. 1994 Oct;38(4):645-67.
PubMed 7805940
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Edema and Pain Following Third Molar Extraction With Application of Pulsed Electromagnetic Field (PEMF) Therapy
- ClinicalTrials.gov ID
- NCT02376946
- Acronym / sponsor ID
- PEMF / 10436
- Conditions
- Postoperative Edema and Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- BioElectronics Corporation
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Posted 1 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, randomized, double-blinded, controlled, clinical trial that evaluates the efficacy of using PEMF in the postoperative period in decreasing swelling and pain after extraction of impacted third molars. The study group will be comprised of subjects that will receive PEMF Actiband treatment for postoperative management of pain and edema. The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema.
Thirty (30) subjects will be randomly assigned to each group. Enrollment will continue until 60 qualified subjects have been recruited. Eligibility criteria will be based on the standards for conducting oral surgery procedures on third molar extractions, in addition to safety considerations and contraindications for the Actiband and other agents to be used. Moreover, the selected subjects will have the same surgical difficulty and surgical trauma anticipated standardized by classification system of impacted third molars. All inclusion and exclusion criteria will be thoroughly explained in the relevant section of this proposal. Postoperative edema and pain will be evaluated using 3dMD and Visual Analog Scale, respectively. Different measurements will be obtained immediately before the surgery and in standard periodic intervals as described in the Materials and Methods section of the proposal. Any difference in postoperative edema, pain, and site responsible for request of rescue pain medication will be compared and analyzed between the two groups.
Detailed description
This study is a prospective, randomized, double-blinded, controlled, clinical trial that evaluates the efficacy of using PEMF in the postoperative period in decreasing swelling and pain after extraction of partial or full/complete boney impacted third molars. The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema. The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema.
Thirty (30) subjects will be randomly assigned to each group. Enrollment will continue until sixty (60) qualified subjects have been recruited. Eligibility criteria will be based on the standards for conducting oral surgery procedures on third molar extractions, in addition to safety considerations and contraindications for the ActiPatch(TM) and other agents to be used. Moreover, the selected subjects will have the same surgical difficulty and surgical trauma anticipated standardized by classification system of impacted third molars. This classification system is utilized in the TUSDM (Tufts University School of Dental Medicine) oral surgery clinic. All inclusion and exclusion criteria will be thoroughly explained in the relevant section of this proposal. Postoperative edema and pain will be evaluated using 3dMD(TM) and Visual Analog Scale, respectively. Different measurements will be obtained immediately before the surgery and in standard periodic intervals as described in the Materials and Methods section of the proposal. Any difference in postoperative edema, pain, and site responsible for request of rescue pain medication will be compared and analyzed between the two groups.
Up to 200 subjects will be enrolled in the study to account for screen failures. Up to forty (40) subjects will be randomly assigned to each group. Recruitment will continue until up to eighty (80) subjects have qualified for study participation. This will allow for up to 25% dropout to end with 60 subjects completing the study.
The primary outcome, postoperative facial swelling at 72 hours (as measured by the 3dMD(TM)), will be compared between the two groups using independent sample t-test if the data are normally distributed, or the Mann Whitney U test if non-parametric methods need to be utilized. This approach will also be utilized for comparing pain (as measured by VAS). The percentage of subjects who will use rescue pain medication due to experience of postoperative pain on the group treated with PEMF ActiPatch(TM) will be compared with the percentage of subjects who will use rescue pain medication due to experience of postoperative pain for the group received placebo, using a Chi-square test. In addition, the volume measurements and the VAS scores will be analyzed using a repeated measures analysis, adjusting for subject age, gender and pain perception. Furthermore, a correlation between placebo group and the use of rescue pain medication will be determined and the association will be dictated by calculating the odds ratio. The statistical significance of this association will be examined using the Chi-square test. All p-values less than 0.025 will be considered statistically significant. Statistical analyses will be performed using SAS, Version 9.2 (SAS Institute, Cary, NC).
An initial 3dMD(TM) scan will be obtained for baseline evaluation at the extraction visit. A second 3dMD(TM) scan will be obtained for evaluation and determination of facial swelling at the 72 hour follow up visit. A third scan will be obtained at the 10 day follow up visit to evaluate the degree of resolution of swelling. The scan will result in a computer-generated image, on which the investigator will outline the area of clinical interest and calculate the volume using integration. The process of surface scanning and volume measurement will use the 3dMD(TM) Vultus software® (3dMD(TM), Atlanta, Georgia, United States).The Vultus software allows for pre and post-surgery superimposition of images as well as quantitative evaluation of surface and volume changes. The PI has had on site training at the Georgia 3dMD facility and had additional training when the camera array was installed. The technique of obtaining the image is straight forward and there is a set of instructions at the installation site for immediate review as necessary. The PI and a representative from 3dMD company will give training to the co-investigators who will be using the device.
The degree of facial swelling between the two groups at the two time points (72 hour follow up and 10 day follow up) will be compared using the data collected from 3dMD(TM). Furthermore, the change in volume between the two scans taken at the 72 hour follow up visit and the 10 day follow up within each group will also be compared. The volumetric difference between the two groups will be analyzed for any statistical significance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actipatch | Active comparator | Device: ActiPatch(TM)The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema. |
| Placebo | Placebo comparator | Device: PlaceboThe control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects of either sex and of any race between the ages of 18 and 30 years. 30 Years old is the upper age limit because wisdom teeth extraction is normally done between the ages of 18 and 30, since after the age of 30 additional complications can arise during surgeries.
- Subjects for whom a decision has been made to extract 2 to 4 third molars. At least two must be classified as full or partially bony impacted (as defined below) of any angulation under local anesthesia alone, local anesthesia and sedation or local anesthesia and general anesthesia all in an outpatient setting.
- Subjects must be physically able to tolerate conventional surgical procedures (ASA I/II)
- Subjects must agree to follow the study protocol.
Key exclusion criteria (7 listed)
- Subjects who are known to be pregnant or think they may be pregnant. (A urine pregnancy test will be performed on female subjects at Day 0 - Visit 1. Subjects testing positive will be excluded from study participation.
- Subjects with a cardiac pacemaker, cardioverter defibrillator, neurostimulator or any active medical or metallic implant (including dental implant).
- Subjects with skeletal immaturity.
- Subjects with self-reported current or history of substance abuse.
- Subjects who are currently receiving any anti-inflammatory or pain medication chronically or they suffer from a chronic pain condition.
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 |
|---|---|---|
| ActiPatch(TM)Also: ActiBand(TM)Assigned by randomization, this study group will be comprised of subjects that receive the PEMF ActiPatch(TM) treatment for postoperative management of pain and edema. | Device | Actipatch |
| PlaceboAssigned by randomization, this control group will be comprised of the subjects that receive a placebo patch as treatment for postoperative management of pain and edema. | Device | Placebo |
Primary outcome
Change in Postoperative Facial Swelling
Time frame: 72 Hours post surgery and 10 days post surgery
The primary outcome, postoperative facial swelling at 72 hours (as measured by the 3dMDTM), will be compared between the two groups using independent sample t-test if the data are normally distributed, or the Mann Whitney U test if non-parametric methods need to be utilized.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6466021Little RC, Ginsburg JM. The physiologic basis for clinical edema. Arch Intern Med. 1984 Aug;144(8):1661-4. doi: 10.1001/archinte.144.8.1661.
- Background: PubMed 10555792Conrad SM, Blakey GH, Shugars DA, Marciani RD, Phillips C, White RP Jr. Patients' perception of recovery after third molar surgery. J Oral Maxillofac Surg. 1999 Nov;57(11):1288-94; discussion 1295-6. doi: 10.1016/s0278-2391(99)90861-3.
- Background: PubMed 402320van Gool AV, Ten Bosch JJ, Boering G. Clinical consequences of complaints and complications after removal of the mandibular third molar. Int J Oral Surg. 1977 Feb;6(1):29-37. doi: 10.1016/s0300-9785(77)80069-0.
- Background: PubMed 15218558Zuniga JR, Phillips CL, Shugars D, Lyon JA, Peroutka SJ, Swarbrick J, Bon C. Analgesic safety and efficacy of diclofenac sodium softgels on postoperative third molar extraction pain. J Oral Maxillofac Surg. 2004 Jul;62(7):806-15. doi: 10.1016/j.joms.2003.12.019.
- Background: PubMed 7844260Urquhart E. Analgesic agents and strategies in the dental pain model. J Dent. 1994 Dec;22(6):336-41. doi: 10.1016/0300-5712(94)90084-1.
- Background: PubMed 12148679Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002 Jul;133(7):861-71. doi: 10.14219/jada.archive.2002.0300.
- Background: PubMed 2395047Troullos ES, Hargreaves KM, Butler DP, Dionne RA. Comparison of nonsteroidal anti-inflammatory drugs, ibuprofen and flurbiprofen, with methylprednisolone and placebo for acute pain, swelling, and trismus. J Oral Maxillofac Surg. 1990 Sep;48(9):945-52. doi: 10.1016/0278-2391(90)90007-o.
- Background: PubMed 7799116Schultze-Mosgau S, Schmelzeisen R, Frolich JC, Schmele H. Use of ibuprofen and methylprednisolone for the prevention of pain and swelling after removal of impacted third molars. J Oral Maxillofac Surg. 1995 Jan;53(1):2-7; discussion 7-8. doi: 10.1016/0278-2391(95)90486-7.
- BackgroundGanzber S. Analgesics: opioids and nonopioids. In: Ciancio S, ed. ADA guide to dental therapeutics. Chicago: ADA Publishing; 1998:80-107.
- Background: PubMed 7805940Dionne RA, Gordon SM. Nonsteroidal anti-inflammatory drugs for acute pain control. Dent Clin North Am. 1994 Oct;38(4):645-67.
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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.
Archana Viswanath principal investigator
Research Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiPatch(TM) in people with Postoperative Edema and Pain, run by Tufts University at 1 site in United States.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 Nov 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Postoperative Facial Swelling (time frame: 72 Hours post surgery and 10 days post surgery). 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 NCT02376946, which also lists 10 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 1 Nov 2021.