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NCT Number: NCT06953440

The Effect of Dexamethasone Submucosal Injection After Surgical Extraction of Lower Impacted Third Molars 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Abdulaziz University, Faculty of Dentistry

Jeddah, Mecca Region, Saudi Arabia

Location status: Recruiting

Location contact

Badr Alharthi, BDS

SUB_INVESTIGATOR

Lojain Bassyoni, BDS, MSc, FRCDC

CONTACT

[email protected]

00966504623553

Lujain Bassyoni, BDS, MS, FRCDC

PRINCIPAL_INVESTIGATOR

Mohammed Bajunaid, BDS

SUB_INVESTIGATOR

Razan Baabdullah, BDS, MS, FRCDC

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone sodium phosphate injection

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Social Interaction

    Time frame: 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.

  2. Work Ability

    Time frame: 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.

  3. Eating Ability

    Time frame: 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.

  4. Sleep Impairment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lojain Bassyoni, BDS, MSc, FRCDC

CONTACT

[email protected]

00966504623553

Razan Baabdullah, BDS, MSc, FRCDC

CONTACT

[email protected]

00966555015167

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

The Effect of Dexamethasone Submucosal Injection After Third Molar Surgery on Trismus and Edema

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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