Swelling/ Edema, Trismus
Conditions
Keywords
Extraction, third molar, wisdom teeth, dexamethasone, steroids, submucosal
Brief 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 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.
Interventions
Patients will receive 4 milligrams of dexamethasone submucosal injection next to the extraction site.
OTHERNormal Saline (Placebo)
Patients will receive 4 milligrams of normal saline solution next to the extraction site.
Sponsors
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
To ensure that the patient and OMFS resident were blinded in this study, the corticosteroid and placebo injections were of the same color and size, were stored in similar syringes, and were coded as drug 1 or drug 2. The OMFS resident received the syringe corresponding to the patient's random allocation prior to the beginning of the procedure. The number of the drug was recorded in the patient file. Then, the drug was 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 were masked to the type of medication used during each surgical procedure. The drugs used in the different surgeries were only revealed after the acquisition and analysis of all data.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trismus and Swelling | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eating Ability | Patients will be followed up in the 2nd, 4th, and 7th postoperative days. | 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. |
| Sleep Impairment | Patients will be followed up in the 2nd, 4th, and 7th postoperative days. | 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. |
| Social Interaction | Patients will be followed up in the 2nd, 4th, and 7th postoperative days. | 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. |
| Work Ability | Patients will be followed up in the 2nd, 4th, and 7th postoperative days. | 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. |
Countries
Saudi Arabia
Contacts
Primary ContactLojain Bassyoni, BDS, MSc, FRCDC
Backup ContactRazan Baabdullah, BDS, MSc, FRCDC
Outcome results
None listed