Temporomandibular Joint DysfunctionNCT05422703
Manual Therapy and Kinesio Taping on Temporomandibular Joint Dysfunction Following Oral Surgeries
A study testing Kinesio tape, Gauze pack and ice pack in people with Temporomandibular Joint Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
Oral surgeries include various types such as impacted wisdom tooth surgery, oral cyst enucleation (cystectomy), surgical incision and drainage of odontogenic abcess, oral tumor excision and open reduction and internal fixation of mandibular fracture (ORIF). Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction
- What is being tested?
- Kinesio tape, Gauze pack and ice pack
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2022to 18 Aug 2022
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age ranged between 20-50 years
- both gender
- TMJ dysfunction following oral surgeries.
Who cannot join
- open wound in affected area
- facial trauma,smoker and infection
- sensitivity to tape
- allergies to medication administered in the study
- reluctance to shave facial hair (for men)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effect of Manual Therapy and Kinesio Taping on Temporomandibular Joint Dysfunction Following Oral Surgeries
Oral surgeries include various types such as impacted wisdom tooth surgery, oral cyst enucleation (cystectomy), surgical incision and drainage of odontogenic abcess, oral tumor excision and open reduction and internal fixation of mandibular fracture (ORIF). Oral surgeries are usually associated with pain, swelling and inability to open the mouth. Those symptoms reach the maximum intensity between the third to fifth days postoperatively for the swelling and 24 to 48 hours postoperatively for the pain and then, they gradually diminished until the 7th day postoperatively
Read the detailed description
Oral surgery concerned with the diagnosis and surgical treatment of congenital or acquired diseases, dysfunction, defects or injuries of the mouth and jaw. Oral surgeries include various types such as impacted wisdom tooth surgery, oral cyst enucleation (cystectomy), surgical incision and drainage of odontogenic abscess, oral tumor excision and open reduction and internal fixation of mandibular fracture (ORIF).
Temporomandibular joint dysfunction: It is one of post operative complications that occur post oral surgeries which include several symptoms as pain,edema and trismus. Pain is the most common and limiting clinical manifestation of this dysfunction, as well as decreased mobility of the jaw, both of which impacts quality of life. The multifactor etiology of temporomandibular joint dysfunction often requires multidisciplinary healthcare professionals to manage difficult symptoms, including chronic pain. Many studies have identified a variety of conservative interventions, such as physical therapy, for patients with temporomandibular joint disorders, including joint mobilization, tissue mobilization,dry needling, friction massage, patient education, splints, modalities, stretching, coordination activities,strengthening exercises, and combinations of these techniques. postoperative major complications such as pain, edema and trismus in various oral surgeries such as tooth extraction, maxillary expansion, and orthognathic surgeries. Oral surgical procedures are often accompanied by a multitude of complications including pain, swelling, and morbidity. These are the result of inflammatory processes induced by the surgical wound healing.
Facial edema: During surgeries, inflammatory chemicals such as prostaglandins, leukotrienes, bradykinins, and platelet-activation factors are secreted by damaged tissue. Moreover, excessive lymph production causes disturbances in local lymphatic circulation. Inflammatory chemicals create endothelial gaps to increase vascular permeability. In addition, macrophages and mast cells in damaged tissues produce histamine, serotonin, and eicosanoids; alter the local constitution of blood vessels; and release nitric oxide, eventually resulting in vasorelaxation. These chain reactions increase blood vessel relaxation and vascular permeability and result in the accumulation of interstitial fluid, eventually resulting in tissue swelling and pain.
Trismus: It is defined as prolonged tetanic spasm of masticatory muscles of jaw. the transient jaw stiffness usually reaches its peak on the 2nd day post surgery. It is diagnosed from clinical examination of the maximal interincisal distance (MID) <40-45 mm caused by contracture and not by obstructive joint impingement.The factors contributing to trismus are: (1) Multiple needle penetrations correlate with a greater incidence of post injection trismus. (2) Elevation of flap beyond the external oblique ridge. (3) At times, the patient hurts his/her own tongue or cheek under the effect of anesthesia resulting in reflex trismus.
kinesio taping (KT) was developed by the Japanese therapist and academic lecturer. More than 30 years ago, he created a special tape, which by the correct application, i.e. sticking with a small stretch (about 15%) to the skin, raises the surface of the skin, thereby increasing the space between the dermis and fascia . The expansion of this space, should reduce lymph retention. The patch used for this method has a thickness and weight similar to skin. The waterproof tape is made of 100% cotton, while the adhesive on the inside is applied in the shape of a fan strip, which allows the air to flow. When stretched beyond its normal length and applied, it recoils and creates a pulling force on the skin, thus improving blood and lymph flow by alleviating hemorrhage and congestion of lymphatic fluid.
Manual therapy (MT) is one of the various types of interventions for treating patients with temporomandibular joint dysfunction and include: Mobilization exercise stretching exercise, coordination exercise, rang of motion exercise and strengthening exercise. Within other body regions, manual therapy intervention has been detailed and summarize the efficacy of treatment approaches.Strengthening, stretching/flexibility, and motor control exercises have demonstrated to be efficacious in reducing pain and disability in patients with chronic low back pain,as well as mechanical neck pain. Despite a review and meta-analysis the efficacy of exercise therapy and dosage has yet to be determined for patients with temporomandibular joint dysfunction. exercises intended to increase mobility of the temporomandibular joint and/or muscles of the jaw. Exercise therapy aims to reduce clinical symptoms such as pain in the muscles and joints, and improve motor function by moving whole or part of the body.Exercise can be classified into self exercise by patients and manual therapy that physiotherapists apply to patients. Self exercise is often offered as home exercise or self-care program that can be done at home. manual exercise therapy includes mobilization, stretch,muscle strengthening exercise and coordination exercise.
- Conditions
- Temporomandibular Joint Dysfunction
- Being tested
- Kinesio tape, Gauze pack, ice pack, Manual therapy, Analgesic
- Keywords
- Kinesio taping, Manual therapy, Oral surgeries
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapeDevice
Skin-colored Kinesiology Tape (ARES tape,5 cm×5 m) is waterproof tape is made of 100% cotton,applied in the shape of a fan strip, waterproof. The width is 5 cm and thickness of 0.5 mm (5 cm×5 m ).This tape is sticking with a small stretch (about 15%).
Gauze packOther
Place gauze pack over surgical site for one hour after surgery.
ice packDevice
Ice packs will be applied for 6 hours after surgery in all patients
Manual therapyProcedure or surgery
Also called Exercises
passive and active range of motion, stretching exercises, resistive mouth exercises, mobilization exercises and coordination exercices.
AnalgesicDrug
NSAIDs like ibuprofen (600-800 mg) or declophenac sodium (50-150 mg) 3 times a day
Proteolytic enzymesDrug
1-2 ampoules daily IM box of 3 ampoules of 5 mg crystallized and lyophilized chymotrypsin (450 E. A. Units) + 3 ampoules of 3 ml apyrogenic saline for one week.
Mouth washDrug
use 0.12% chlorhexidine or povidone iodine mouthwash daily
Soft cold dietDietary supplement
For the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | patients who will receive manual therapy and Kinesio taping, in additional to basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ) 3 times per week for two weeks. Receives: Device: Kinesio tape; Other: Gauze pack; Device: ice pack; Procedure: Manual therapy; Drug: Analgesic; Drug: Proteolytic enzymes; Drug: Mouth wash; Dietary Supplement: Soft cold diet |
| Control group | Placebo comparator | patients who will receive basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ). Receives: Other: Gauze pack; Device: ice pack; Drug: Analgesic; Drug: Proteolytic enzymes; Drug: Mouth wash; Dietary Supplement: Soft cold diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
facial swelling
Facial swelling was assessed by a four-line measurement method using a flexible plastic tape measure. The corresponding lines were line A from the most posterior point of the tragus to the most lateral point of the lip commissure),line B (from the most posterior point of the tragus to the pogonion), line C from the most inferior point of the mandibular angle to lateral canthus of the eye ; and line D, most inferior point of the mandibular angle to (the nasal border - wing of the nostril. These measurements were performed with the patient sitting at 90° straight position with physiologic rest position of the mandible.
Measured: Two weeks
Facial pain
Visual analogue scale (VAS)measure, consists of a line usually 10 cm in length, with anchor descriptors such as (in the pain context) where 0 means no pain and 10 means worst conceivable pain. patients asked to mark the point corresponding to the intensity of their pain , and the distance from the left endpoint to the mark is measured, in cm.
Measured: Two weeks
Maximum mouth opening
measurement of maximal interincisal distance (mm) attained during the active mouth opening by the subject.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start15 Jan 2022
- Primary completion18 Jun 2022
- Study completion18 Aug 2022
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 Temporomandibular Joint DysfunctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Kamal Mousa Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422703
- Sponsor's protocol ID
- P.T.REC/012/003508
- Status last verified
- May 2025
- First submitted
- 10 Jun 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lietz-Kijak D, Kijak E, Krajczy M, Bogacz K, Luniewski J, Szczegielniak J. The Impact of the Use of Kinesio Taping Method on the Reduction of Swelling in Patients After Orthognathic Surgery: A Pilot Study. Med Sci Monit. 2018 Jun 4;24:3736-3743. doi: 10.12659/MSM.909915.
PubMed 29861496Yurttutan ME, Sancak KT. The effect of kinesio taping with the web strip technique on pain, edema, and trismus after impacted mandibular third molar surgery. Niger J Clin Pract. 2020 Sep;23(9):1260-1265. doi: 10.4103/njcp.njcp_23_20.
PubMed 32913166Jaron A, Preuss O, Grzywacz E, Trybek G. The Impact of Using Kinesio Tape on Non-Infectious Complications after Impacted Mandibular Third Molar Surgery. Int J Environ Res Public Health. 2021 Jan 6;18(2):399. doi: 10.3390/ijerph18020399.
PubMed 33419167Tatli U, Benlidayi IC, Salimov F, Guzel R. Effectiveness of kinesio taping on postoperative morbidity after impacted mandibular third molar surgery: a prospective, randomized, placebo-controlled clinical study. J Appl Oral Sci. 2020;28:e20200159. doi: 10.1590/1678-7757-2020-0159. Epub 2020 Jul 13.
PubMed 32667383
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Manual Therapy and Kinesio Taping on Temporomandibular Joint Dysfunction Following Oral Surgeries
- ClinicalTrials.gov ID
- NCT05422703
- Acronym / sponsor ID
- P.T.REC/012/003508
- Conditions
- Temporomandibular Joint Dysfunction
- Keywords
- Kinesio taping, Manual therapy, Oral surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 18 Jun 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 16 Jun 2022 (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.
Oral surgeries include various types such as impacted wisdom tooth surgery, oral cyst enucleation (cystectomy), surgical incision and drainage of odontogenic abcess, oral tumor excision and open reduction and internal fixation of mandibular fracture (ORIF). Oral surgeries are usually associated with pain, swelling and inability to open the mouth. Those symptoms reach the maximum intensity between the third to fifth days postoperatively for the swelling and 24 to 48 hours postoperatively for the pain and then, they gradually diminished until the 7th day postoperatively
Detailed description
Oral surgery concerned with the diagnosis and surgical treatment of congenital or acquired diseases, dysfunction, defects or injuries of the mouth and jaw. Oral surgeries include various types such as impacted wisdom tooth surgery, oral cyst enucleation (cystectomy), surgical incision and drainage of odontogenic abscess, oral tumor excision and open reduction and internal fixation of mandibular fracture (ORIF).
Temporomandibular joint dysfunction: It is one of post operative complications that occur post oral surgeries which include several symptoms as pain,edema and trismus. Pain is the most common and limiting clinical manifestation of this dysfunction, as well as decreased mobility of the jaw, both of which impacts quality of life. The multifactor etiology of temporomandibular joint dysfunction often requires multidisciplinary healthcare professionals to manage difficult symptoms, including chronic pain. Many studies have identified a variety of conservative interventions, such as physical therapy, for patients with temporomandibular joint disorders, including joint mobilization, tissue mobilization,dry needling, friction massage, patient education, splints, modalities, stretching, coordination activities,strengthening exercises, and combinations of these techniques. postoperative major complications such as pain, edema and trismus in various oral surgeries such as tooth extraction, maxillary expansion, and orthognathic surgeries. Oral surgical procedures are often accompanied by a multitude of complications including pain, swelling, and morbidity. These are the result of inflammatory processes induced by the surgical wound healing.
Facial edema: During surgeries, inflammatory chemicals such as prostaglandins, leukotrienes, bradykinins, and platelet-activation factors are secreted by damaged tissue. Moreover, excessive lymph production causes disturbances in local lymphatic circulation. Inflammatory chemicals create endothelial gaps to increase vascular permeability. In addition, macrophages and mast cells in damaged tissues produce histamine, serotonin, and eicosanoids; alter the local constitution of blood vessels; and release nitric oxide, eventually resulting in vasorelaxation. These chain reactions increase blood vessel relaxation and vascular permeability and result in the accumulation of interstitial fluid, eventually resulting in tissue swelling and pain.
Trismus: It is defined as prolonged tetanic spasm of masticatory muscles of jaw. the transient jaw stiffness usually reaches its peak on the 2nd day post surgery. It is diagnosed from clinical examination of the maximal interincisal distance (MID) <40-45 mm caused by contracture and not by obstructive joint impingement.The factors contributing to trismus are: (1) Multiple needle penetrations correlate with a greater incidence of post injection trismus. (2) Elevation of flap beyond the external oblique ridge. (3) At times, the patient hurts his/her own tongue or cheek under the effect of anesthesia resulting in reflex trismus.
kinesio taping (KT) was developed by the Japanese therapist and academic lecturer. More than 30 years ago, he created a special tape, which by the correct application, i.e. sticking with a small stretch (about 15%) to the skin, raises the surface of the skin, thereby increasing the space between the dermis and fascia . The expansion of this space, should reduce lymph retention. The patch used for this method has a thickness and weight similar to skin. The waterproof tape is made of 100% cotton, while the adhesive on the inside is applied in the shape of a fan strip, which allows the air to flow. When stretched beyond its normal length and applied, it recoils and creates a pulling force on the skin, thus improving blood and lymph flow by alleviating hemorrhage and congestion of lymphatic fluid.
Manual therapy (MT) is one of the various types of interventions for treating patients with temporomandibular joint dysfunction and include: Mobilization exercise stretching exercise, coordination exercise, rang of motion exercise and strengthening exercise. Within other body regions, manual therapy intervention has been detailed and summarize the efficacy of treatment approaches.Strengthening, stretching/flexibility, and motor control exercises have demonstrated to be efficacious in reducing pain and disability in patients with chronic low back pain,as well as mechanical neck pain. Despite a review and meta-analysis the efficacy of exercise therapy and dosage has yet to be determined for patients with temporomandibular joint dysfunction. exercises intended to increase mobility of the temporomandibular joint and/or muscles of the jaw. Exercise therapy aims to reduce clinical symptoms such as pain in the muscles and joints, and improve motor function by moving whole or part of the body.Exercise can be classified into self exercise by patients and manual therapy that physiotherapists apply to patients. Self exercise is often offered as home exercise or self-care program that can be done at home. manual exercise therapy includes mobilization, stretch,muscle strengthening exercise and coordination exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Kinesio tape, Other: Gauze pack, Device: ice pack, Procedure: Manual therapy, Drug: Analgesic, Drug: Proteolytic enzymes, Drug: Mouth wash, Dietary Supplement: Soft cold dietpatients who will receive manual therapy and Kinesio taping, in additional to basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ) 3 times per week for two weeks. |
| Control group | Placebo comparator | Other: Gauze pack, Device: ice pack, Drug: Analgesic, Drug: Proteolytic enzymes, Drug: Mouth wash, Dietary Supplement: Soft cold dietpatients who will receive basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age ranged between 20-50 years
- both gender
- TMJ dysfunction following oral surgeries.
Key exclusion criteria (5 listed)
- open wound in affected area
- facial trauma,smoker and infection
- sensitivity to tape
- allergies to medication administered in the study
- reluctance to shave facial hair (for men)
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 |
|---|---|---|
| Kinesio tapeSkin-colored Kinesiology Tape (ARES tape,5 cm×5 m) is waterproof tape is made of 100% cotton,applied in the shape of a fan strip, waterproof. The width is 5 cm and thickness of 0.5 mm (5 cm×5 m ).This tape is sticking with a small stretch (about 15%). | Device | Study group |
| Gauze packPlace gauze pack over surgical site for one hour after surgery. | Other | Control group, Study group |
| ice packIce packs will be applied for 6 hours after surgery in all patients | Device | Control group, Study group |
| Manual therapyAlso: Exercisespassive and active range of motion, stretching exercises, resistive mouth exercises, mobilization exercises and coordination exercices. | Procedure or surgery | Study group |
| AnalgesicNSAIDs like ibuprofen (600-800 mg) or declophenac sodium (50-150 mg) 3 times a day | Drug | Control group, Study group |
| Proteolytic enzymes1-2 ampoules daily IM box of 3 ampoules of 5 mg crystallized and lyophilized chymotrypsin (450 E. A. Units) + 3 ampoules of 3 ml apyrogenic saline for one week. | Drug | Control group, Study group |
| Mouth washuse 0.12% chlorhexidine or povidone iodine mouthwash daily | Drug | Control group, Study group |
| Soft cold dietFor the day of surgery | Dietary supplement | Control group, Study group |
Primary outcome
facial swelling
Time frame: Two weeks
Facial swelling was assessed by a four-line measurement method using a flexible plastic tape measure. The corresponding lines were line A from the most posterior point of the tragus to the most lateral point of the lip commissure),line B (from the most posterior point of the tragus to the pogonion), line C from the most inferior point of the mandibular angle to lateral canthus of the eye ; and line D, most inferior point of the mandibular angle to (the nasal border - wing of the nostril. These measurements were performed with the patient sitting at 90° straight position with physiologic rest position of the mandible.
Facial pain
Time frame: Two weeks
Visual analogue scale (VAS)measure, consists of a line usually 10 cm in length, with anchor descriptors such as (in the pain context) where 0 means no pain and 10 means worst conceivable pain. patients asked to mark the point corresponding to the intensity of their pain , and the distance from the left endpoint to the mark is measured, in cm.
Maximum mouth opening
Time frame: Two weeks
measurement of maximal interincisal distance (mm) attained during the active mouth opening by the subject.
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 21 May 2025.
- Background: PubMed 29861496Lietz-Kijak D, Kijak E, Krajczy M, Bogacz K, Luniewski J, Szczegielniak J. The Impact of the Use of Kinesio Taping Method on the Reduction of Swelling in Patients After Orthognathic Surgery: A Pilot Study. Med Sci Monit. 2018 Jun 4;24:3736-3743. doi: 10.12659/MSM.909915.
- Background: PubMed 32913166Yurttutan ME, Sancak KT. The effect of kinesio taping with the web strip technique on pain, edema, and trismus after impacted mandibular third molar surgery. Niger J Clin Pract. 2020 Sep;23(9):1260-1265. doi: 10.4103/njcp.njcp_23_20.
- Background: PubMed 33419167Jaron A, Preuss O, Grzywacz E, Trybek G. The Impact of Using Kinesio Tape on Non-Infectious Complications after Impacted Mandibular Third Molar Surgery. Int J Environ Res Public Health. 2021 Jan 6;18(2):399. doi: 10.3390/ijerph18020399.
- Background: PubMed 32667383Tatli U, Benlidayi IC, Salimov F, Guzel R. Effectiveness of kinesio taping on postoperative morbidity after impacted mandibular third molar surgery: a prospective, randomized, placebo-controlled clinical study. J Appl Oral Sci. 2020;28:e20200159. doi: 10.1590/1678-7757-2020-0159. Epub 2020 Jul 13.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio tape, Gauze pack and ice pack in people with Temporomandibular Joint Dysfunction, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 5 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 21 May 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 Egypt. 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?
facial swelling (time frame: Two weeks). The study lists 3 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 NCT05422703, 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 21 May 2025.