Swelling/ EdemaPhase 4NCT06953440
The Effect of Dexamethasone Submucosal Injection After Surgical Extraction of Lower Impacted Third Molars on Trismus and Edema
A Phase 4 study testing Dexamethasone Sodium Phosphate Injection in people with Swelling/ Edema and Trismus, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
This clinical trial aims to investigate whether dexamethasone decreases edema and trismus in adults undergoing lower third molar surgical extraction. The main question it aims to answer is: Does dexamethasone submucosal injection have a positive impact on trismus and edema after third molar surgery compared to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Swelling/ Edema, Trismus
- What is being tested?
- Dexamethasone Sodium Phosphate Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2024to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with impacted lower third molars requiring surgical extraction.
- Adults over the age of 18 years old.
- American Society of Anaesthesiologists (ASA) 1, and ASA 2
Who cannot join
- Patients with preoperative intraoral or extraoral swelling.
- Patients requiring simple extraction (Class I group A according to Pell and ---Gregory classification).
- Patients with uncontrolled systemic disease such as uncontrolled diabetic - patients.
- Patients who are allergic to corticosteroids.
- Patients who are contraindicated to use corticosteroids such as uncontrolled diabetic patients, and osteoporotic patients.
- Patients who require extraction of additional teeth at the same visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz University, Faculty of Dentistry
Jeddah, Mecca Region
Lojain Bassyoni, BDS, MSc, FRCDC, 00966504623553, lbassyoni@kau.edu.sa
Lujain Bassyoni, BDS, MS, FRCDC
About this study
Official title: The Effect of Dexamethasone Submucosal Injection After Third Molar Surgery on Trismus and Edema
This clinical trial aims to investigate whether dexamethasone decreases edema and trismus in adults undergoing lower third molar surgical extraction.
The main question it aims to answer is:
Does dexamethasone submucosal injection have a positive impact on trismus and edema after third molar surgery compared to conventional postoperative prescription?
Participants will:
- Be administered with dexamethasone submucosal injection or a placebo after the surgery.
- Visit the clinic three times the week after the extraction for follow-up.
Read the detailed description
Patients will be randomly allocated to the test group or the control group by an allocation sequence that is done by the statistician.
To ensure that the patient and OMFS resident are blinded in this study, the corticosteroid and placebo injections are of the same color and size, are stored in similar bottles, and are coded as drug 1 or drug 2. Additionally, they will be placed in sealed envelopes by a dental assistant.
The OMFS resident will withdraw an envelope randomly. The number is recorded in the patient file. Then, the drug will be administered in the buccal vestibule next to the site of extraction after surgery. Thus, the patient, surgeon, and the person responsible for the assessments of swelling and trismus are masked to the type of medication used during each surgical procedure. The drugs used in the different surgeries are only revealed after the acquisition and analysis of all data. Baseline and follow-up measurements will be measured by a standardized ruler. At the first visit, interincisal distance will be recorded to measure trismus. Distance from the angle of the mandible to the outer canthus of the eye, distance from the tragus of the ear to the corner of the mouth, and distance from the tragus of the ear to soft tissue pogonion will be recorded and their mean will be calculated to measure edema. Pell and Gregory classification of the tooth and impaction angulation will be recorded. Facial symmetry and whether the angle of the mandible is palpable or not will be recorded as well. The number of drug that was given to the patient will be recorded.
At the 2nd, 4th, and 7th visits, interincisal distance will be recorded to measure trismus. Distance from the angle of the mandible to the outer canthus of the eye, distance from the tragus of the ear to the corner of the mouth, and distance from the tragus of the ear to soft tissue pogonion will be recorded to measure edema. Facial symmetry and whether the angle of the mandible is palpable or not will be recorded. Whether the patient is able to interact socially or not. If not, was it due to edema, feeling sick, or bad mood. The patient's ability to work, the patient\'s ability to eat the food he is used to eating, and the presence of sleep impairment will be recorded as well.
Surgery will be done by calibrated OMFS residents. After the surgery, the surgeon will use the preassigned randomly picked envelope and administer it in the buccal vestibule next to the surgical site. Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
- Conditions
- Swelling/ Edema, Trismus
- Being tested
- Dexamethasone Sodium Phosphate Injection, Normal Saline (Placebo)
- Keywords
- Extraction, third molar, wisdom teeth, dexamethasone, steroids, submucosal
- Medical subject headings
- Edema, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Sodium Phosphate InjectionDrug
Patients will receive 4 milligrams of dexamethasone submucosal injection next to the extraction site.
Normal Saline (Placebo)Other
Patients will receive 4 milligrams of normal saline solution next to the extraction site.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Group | Experimental | Patient received 4 milligrams of dexamethasone Receives: Drug: Dexamethasone Sodium Phosphate Injection |
| Control Group | Placebo comparator | Patient received 4 milligrams of normal saline solution Receives: Other: Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trismus and Swelling
Baseline and follow-up measurements will be measured by a standardized ruler. At the first visit, interincisal distance will be recorded in millimeters to measure trismus. Distance from the angle of the mandible to the outer canthus of the eye, distance from the tragus of the ear to the corner of the mouth, and distance from the tragus of the ear to soft tissue pogonion will be recorded in millimeters and their mean will be calculated to measure edema. Pell and Gregory classification of the tooth and impaction angulation will be recorded. Facial symmetry and whether the angle of the mandible is palpable or not will be recorded as well.
At the 2nd, 4th, and 7th visits, interincisal distance will be recorded in millimeters to measure trismus. Distance from the angle of the mandible to the outer canthus of the eye, distance from the tragus of the ear to the corner of the mouth, and distance from the tragus of the ear to soft tissue pogonion will be recorded in millimeters
Measured: From the day of extraction, the 2nd day of surgery, 4th day, and 7th day of surgery.
Secondary outcomes (4)
Social Interaction
Whether the patient is able to interact socially or not, if not, was it due to edema, feeling sick, or bad mood.
The patient will be asked a yes or no question, and their answer will be recorded.
Measured: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Work Ability
Whether the patient is able to work on his job or perform daily chores.
The patient will be asked a yes or no question, and their answer will be recorded.
Measured: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Eating Ability
Whether the patient can eat the food he is used to.
The patient will be asked a yes or no question, and their answer will be recorded.
Measured: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Sleep Impairment
Whether the patient is able to sleep without impairment.
The patient will be asked a yes or no question, and their answer will be recorded.
Measured: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Feb 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Swelling/ 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups. The test group will receive 4mg/1ml dexamethasone submucosal injection at the buccal vestibule next to the surgical site. The control group will receive 1 ml of normal saline injection in the buccal vestibule next to the surgical site. The primary objective of this study is to compare mean change in trismus and mean edema between 2 independent groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lojain Bassyoni, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953440
- Sponsor's protocol ID
- 225-11-23
- Status last verified
- Apr 2025
- First submitted
- 11 Feb 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data gathered and agreed upon by the institution's research ethical committee throughout the conduction of the clinical trial will be shared at the time of publication.
Publications
Hou C, Liu F, Liu C. Comparison of Submucosal With Intramuscular or Intravenous Administration of Dexamethasone for Third Molar Surgeries: A Systematic Review and Meta-Analysis. Front Surg. 2021 Aug 10;8:714950. doi: 10.3389/fsurg.2021.714950. eCollection 2021.
PubMed 34447785Grossi GB, Maiorana C, Garramone RA, Borgonovo A, Beretta M, Farronato D, Santoro F. Effect of submucosal injection of dexamethasone on postoperative discomfort after third molar surgery: a prospective study. J Oral Maxillofac Surg. 2007 Nov;65(11):2218-26. doi: 10.1016/j.joms.2006.11.036.
PubMed 17954317Wanithanont P, Chaiyasamut T, Vongsavan K, Bhattarai BP, Pairuchvej V, Kiattavorncharoen S, Wongsirichat N. Comparative efficiency of the preoperative pterygomandibular space injection of two doses of dexamethasone in mandibular third molar surgery. J Dent Anesth Pain Med. 2021 Feb;21(1):29-39. doi: 10.17245/jdapm.2021.21.1.29. Epub 2021 Jan 29.
PubMed 33585682Warraich R, Faisal M, Rana M, Shaheen A, Gellrich NC, Rana M. Evaluation of postoperative discomfort following third molar surgery using submucosal dexamethasone - a randomized observer blind prospective study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Jul;116(1):16-22. doi: 10.1016/j.oooo.2012.12.007. Epub 2013 Feb 28.
PubMed 23453611Mojsa IM, Pokrowiecki R, Lipczynski K, Czerwonka D, Szczeklik K, Zaleska M. Effect of submucosal dexamethasone injection on postoperative pain, oedema, and trismus following mandibular third molar surgery: a prospective, randomized, double-blind clinical trial. Int J Oral Maxillofac Surg. 2017 Apr;46(4):524-530. doi: 10.1016/j.ijom.2016.11.006. Epub 2016 Dec 21.
PubMed 28012633Parhizkar P, Schmidlin PR, Bornstein MM, Fakheran O. Can adjunctive corticosteroid therapy improve patient-centered outcomes following third molar surgery? A systematic review. Med Oral Patol Oral Cir Bucal. 2022 Sep 1;27(5):e410-e418. doi: 10.4317/medoral.25177.
PubMed 35975802Moraschini V, Hidalgo R, Porto Barboza Ed. Effect of submucosal injection of dexamethasone after third molar surgery: a meta-analysis of randomized controlled trials. Int J Oral Maxillofac Surg. 2016 Feb;45(2):232-40. doi: 10.1016/j.ijom.2015.09.008. Epub 2015 Oct 14.
PubMed 26458538Kiencalo A, Jamka-Kasprzyk M, Panas M, Wyszynska-Pawelec G. Analysis of complications after the removal of 339 third molars. Dent Med Probl. 2021 Jan-Mar;58(1):75-80. doi: 10.17219/dmp/127028.
PubMed 33789003Aljafar A, Alibrahim H, Alahmed A, AbuAli A, Nazir M, Alakel A, Almas K. Reasons for Permanent Teeth Extractions and Related Factors among Adult Patients in the Eastern Province of Saudi Arabia. ScientificWorldJournal. 2021 Feb 22;2021:5534455. doi: 10.1155/2021/5534455. eCollection 2021.
PubMed 33688305
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone Submucosal Injection After Third Molar Surgery on Trismus and Edema
- ClinicalTrials.gov ID
- NCT06953440
- Acronym / sponsor ID
- 225-11-23
- Conditions
- Swelling/ Edema, Trismus
- Keywords
- Extraction, third molar, wisdom teeth, dexamethasone, steroids, submucosal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 May 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.
This clinical trial aims to investigate whether dexamethasone decreases edema and trismus in adults undergoing lower third molar surgical extraction.
The main question it aims to answer is:
Does dexamethasone submucosal injection have a positive impact on trismus and edema after third molar surgery compared to conventional postoperative prescription?
Participants will:
- Be administered with dexamethasone submucosal injection or a placebo after the surgery.
- Visit the clinic three times the week after the extraction for follow-up.
Detailed description
Patients will be randomly allocated to the test group or the control group by an allocation sequence that is done by the statistician.
To ensure that the patient and OMFS resident are blinded in this study, the corticosteroid and placebo injections are of the same color and size, are stored in similar bottles, and are coded as drug 1 or drug 2. Additionally, they will be placed in sealed envelopes by a dental assistant.
The OMFS resident will withdraw an envelope randomly. The number is recorded in the patient file. Then, the drug will be administered in the buccal vestibule next to the site of extraction after surgery. Thus, the patient, surgeon, and the person responsible for the assessments of swelling and trismus are masked to the type of medication used during each surgical procedure. The drugs used in the different surgeries are only revealed after the acquisition and analysis of all data. Baseline and follow-up measurements will be measured by a standardized ruler. At the first visit, interincisal distance will be recorded to measure trismus. Distance from the angle of the mandible to the outer canthus of the eye, distance from the tragus of the ear to the corner of the mouth, and distance from the tragus of the ear to soft tissue pogonion will be recorded and their mean will be calculated to measure edema. Pell and Gregory classification of the tooth and impaction angulation will be recorded. Facial symmetry and whether the angle of the mandible is palpable or not will be recorded as well. The number of drug that was given to the patient will be recorded.
At the 2nd, 4th, and 7th visits, interincisal distance will be recorded to measure trismus. Distance from the angle of the mandible to the outer canthus of the eye, distance from the tragus of the ear to the corner of the mouth, and distance from the tragus of the ear to soft tissue pogonion will be recorded to measure edema. Facial symmetry and whether the angle of the mandible is palpable or not will be recorded. Whether the patient is able to interact socially or not. If not, was it due to edema, feeling sick, or bad mood. The patient's ability to work, the patient\'s ability to eat the food he is used to eating, and the presence of sleep impairment will be recorded as well.
Surgery will be done by calibrated OMFS residents. After the surgery, the surgeon will use the preassigned randomly picked envelope and administer it in the buccal vestibule next to the surgical site. Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- There will be two groups. The test group will receive 4mg/1ml dexamethasone submucosal injection at the buccal vestibule next to the surgical site. The control group will receive 1 ml of normal saline injection in the buccal vestibule next to the surgical site. The primary objective of this study is to compare mean change in trismus and mean edema between 2 independent groups.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Group | Experimental | Drug: Dexamethasone Sodium Phosphate InjectionPatient received 4 milligrams of dexamethasone |
| Control Group | Placebo comparator | Other: Normal Saline (Placebo)Patient received 4 milligrams of normal saline solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with impacted lower third molars requiring surgical extraction.
- Adults over the age of 18 years old.
- American Society of Anaesthesiologists (ASA) 1, and ASA 2
Key exclusion criteria (6 listed)
- Patients with preoperative intraoral or extraoral swelling.
- Patients requiring simple extraction (Class I group A according to Pell and ---Gregory classification).
- Patients with uncontrolled systemic disease such as uncontrolled diabetic - patients.
- Patients who are allergic to corticosteroids.
- Patients who are contraindicated to use corticosteroids such as uncontrolled diabetic patients, and osteoporotic patients.
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 |
|---|---|---|
| Dexamethasone Sodium Phosphate InjectionPatients will receive 4 milligrams of dexamethasone submucosal injection next to the extraction site. | Drug | Dexamethasone Group |
| Normal Saline (Placebo)Patients will receive 4 milligrams of normal saline solution next to the extraction site. | Other | Control Group |
Primary outcome
Trismus and Swelling
Time frame: From the day of extraction, the 2nd day of surgery, 4th day, and 7th day of surgery.
Baseline and follow-up measurements will be measured by a standardized ruler. At the first visit, interincisal distance will be recorded in millimeters to measure trismus. Distance from the angle of the mandible to the outer canthus of the eye, distance from the tragus of the ear to the corner of the mouth, and distance from the tragus of the ear to soft tissue pogonion will be recorded in millimeters and their mean will be calculated to measure edema. Pell and Gregory classification of the tooth and impaction angulation will be recorded. Facial symmetry and whether the angle of the mandible is palpable or not will be recorded as well. At the 2nd, 4th, and 7th visits, interincisal distance will be recorded in millimeters to measure trismus. Distance from the angle of the mandible to the outer canthus of the eye, distance from the tragus of the ear to the corner of the mouth, and distance from the tragus of the ear to soft tissue pogonion will be recorded in millimeters
4 secondary outcomes
Social Interaction
Time frame: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Work Ability
Time frame: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Eating Ability
Time frame: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Sleep Impairment
Time frame: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Background: PubMed 34447785Hou C, Liu F, Liu C. Comparison of Submucosal With Intramuscular or Intravenous Administration of Dexamethasone for Third Molar Surgeries: A Systematic Review and Meta-Analysis. Front Surg. 2021 Aug 10;8:714950. doi: 10.3389/fsurg.2021.714950. eCollection 2021.
- Background: PubMed 17954317Grossi GB, Maiorana C, Garramone RA, Borgonovo A, Beretta M, Farronato D, Santoro F. Effect of submucosal injection of dexamethasone on postoperative discomfort after third molar surgery: a prospective study. J Oral Maxillofac Surg. 2007 Nov;65(11):2218-26. doi: 10.1016/j.joms.2006.11.036.
- Background: PubMed 33585682Wanithanont P, Chaiyasamut T, Vongsavan K, Bhattarai BP, Pairuchvej V, Kiattavorncharoen S, Wongsirichat N. Comparative efficiency of the preoperative pterygomandibular space injection of two doses of dexamethasone in mandibular third molar surgery. J Dent Anesth Pain Med. 2021 Feb;21(1):29-39. doi: 10.17245/jdapm.2021.21.1.29. Epub 2021 Jan 29.
- Background: PubMed 23453611Warraich R, Faisal M, Rana M, Shaheen A, Gellrich NC, Rana M. Evaluation of postoperative discomfort following third molar surgery using submucosal dexamethasone - a randomized observer blind prospective study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Jul;116(1):16-22. doi: 10.1016/j.oooo.2012.12.007. Epub 2013 Feb 28.
- Background: PubMed 28012633Mojsa IM, Pokrowiecki R, Lipczynski K, Czerwonka D, Szczeklik K, Zaleska M. Effect of submucosal dexamethasone injection on postoperative pain, oedema, and trismus following mandibular third molar surgery: a prospective, randomized, double-blind clinical trial. Int J Oral Maxillofac Surg. 2017 Apr;46(4):524-530. doi: 10.1016/j.ijom.2016.11.006. Epub 2016 Dec 21.
- Background: PubMed 35975802Parhizkar P, Schmidlin PR, Bornstein MM, Fakheran O. Can adjunctive corticosteroid therapy improve patient-centered outcomes following third molar surgery? A systematic review. Med Oral Patol Oral Cir Bucal. 2022 Sep 1;27(5):e410-e418. doi: 10.4317/medoral.25177.
- Background: PubMed 26458538Moraschini V, Hidalgo R, Porto Barboza Ed. Effect of submucosal injection of dexamethasone after third molar surgery: a meta-analysis of randomized controlled trials. Int J Oral Maxillofac Surg. 2016 Feb;45(2):232-40. doi: 10.1016/j.ijom.2015.09.008. Epub 2015 Oct 14.
- Background: PubMed 33789003Kiencalo A, Jamka-Kasprzyk M, Panas M, Wyszynska-Pawelec G. Analysis of complications after the removal of 339 third molars. Dent Med Probl. 2021 Jan-Mar;58(1):75-80. doi: 10.17219/dmp/127028.
- Background: PubMed 33688305Aljafar A, Alibrahim H, Alahmed A, AbuAli A, Nazir M, Alakel A, Almas K. Reasons for Permanent Teeth Extractions and Related Factors among Adult Patients in the Eastern Province of Saudi Arabia. ScientificWorldJournal. 2021 Feb 22;2021:5534455. doi: 10.1155/2021/5534455. eCollection 2021.
- Google drive link that contains all information regarding the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. All data gathered and agreed upon by the institution's research ethical committee throughout the conduction of the clinical trial will be shared at the time of publication.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Sodium Phosphate Injection in people with Swelling/ Edema and Trismus, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 6 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: looking for participants now, as of the sponsor's last update on 1 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 Saudi Arabia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lojain Bassyoni, BDS, MSc, FRCDC (00966504623553, lbassyoni@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trismus and Swelling (time frame: From the day of extraction, the 2nd day of surgery, 4th day, and 7th day of 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 NCT06953440, which also lists 9 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 May 2025.