The Effect of Dexamethasone Submucosal Injection After Surgical Extraction of Lower Impacted Third Molars on Trismus and Edema

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKing Abdulaziz University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone Sodium Phosphate Injection

    Drug

    Patients will receive 4 milligrams of dexamethasone submucosal injection next to the extraction site.

  • Normal Saline (Placebo)

    Other intervention

    Patients will receive 4 milligrams of normal saline solution next to the extraction site.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Dexamethasone GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

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