A Phase 4 interventional study of Dexamethasone Sodium Phosphate Injection and Normal Saline (Placebo) in Swelling/ Edema and Trismus, sponsored by King Abdulaziz University. Recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by King Abdulaziz University · Phase 4, Interventional, and Supportive care
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:
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.
566 studies on the registry are indexed under Edema; 95 are open to participants now.
This study's planned enrollment of 66 is above the median of 52 across 401 interventional studies indexed under Edema.
Browse Edema studies →King Abdulaziz University is the lead sponsor of 98 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient received 4 milligrams of dexamethasone
Drug: Dexamethasone Sodium Phosphate Injection
Patient received 4 milligrams of normal saline solution
Other: Normal Saline (Placebo)
Patients will receive 4 milligrams of dexamethasone submucosal injection next to the extraction site.
Patients will receive 4 milligrams of normal saline solution next to the extraction site.
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
Time frame: From the day of extraction, the 2nd day of surgery, 4th day, and 7th day of surgery.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Plan to share: 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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Studies of the drug tested here: Dexamethasone phosphate
King Abdulaziz University