Impacted Mandibular Third MolarNCT07450638
Effect of Preoperative Long-Acting Corticosteroids on Pain, Swelling, and Trismus After Impacted Lower Third Molar Surgery
A study testing Dexamethasone 8 mg IM and Normal Saline IM in people with Impacted Mandibular Third Molar and Postoperative Pain, run by Al Salam University at 1 site in Egypt.
Trial summary
This study evaluated whether giving a single dose of long-acting corticosteroids before wisdom tooth surgery reduces pain, facial swelling, and limited jaw opening (trismus) after surgery. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Mandibular Third Molar, Postoperative Pain, Trismus
- What is being tested?
- Dexamethasone 8 mg IM and Normal Saline IM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jan 2026to 15 Apr 2026
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-35 years
- Indicated for surgical removal of impacted mandibular third molars (Pell \& Gregory Class II-III)
- ASA I or II (healthy or mild systemic disease)
- Willing to provide informed consent
Who cannot join
- Known allergy to corticosteroids
- Systemic diseases contraindicating steroid use (e.g., uncontrolled diabetes, immunosuppression)
- Pregnancy or lactation
- Acute pericoronitis or local infection
- Current use of steroids or NSAIDs
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Oral & Maxillofacial Surgery, Al Salam University
Tanta, Gharbia Governorate
About this study
Official title: Efficacy of Preoperative Long-acting Corticosteroids on Postoperative Pain, Swelling, and Trismus Following Impacted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Trial.
This study evaluated whether giving a single dose of long-acting corticosteroids before wisdom tooth surgery reduces pain, facial swelling, and limited jaw opening (trismus) after surgery. Adult patients aged 18-35 undergoing impacted lower wisdom tooth removal were randomly assigned to receive either 8 mg dexamethasone or a placebo before surgery. Pain, swelling, and jaw mobility were measured at several time points after surgery. The study aimed to determine if preoperative corticosteroids improve recovery and reduce discomfort following surgery.
Read the detailed description
Surgical removal of impacted lower wisdom teeth often causes pain, swelling, and reduced jaw opening (trismus) due to tissue inflammation. This study examined whether giving a single dose of long-acting corticosteroids before surgery could reduce these postoperative problems.
Adult patients aged 18-35 years who required surgical extraction of impacted mandibular third molars were randomly assigned to receive either 8 mg dexamethasone (treatment group) or a placebo (control group) 30 minutes before surgery. The study measured pain using a visual analog scale, facial swelling with standard facial landmarks, and jaw opening with calipers at multiple time points after surgery. Analgesic consumption was also recorded.
The goal was to determine whether preoperative corticosteroid administration could improve recovery, reduce discomfort, and enhance patient comfort after third molar surgery. This information may help guide oral surgeons in postoperative care and improve outcomes for patients undergoing similar procedures.
- Being tested
- Dexamethasone 8 mg IM, Normal Saline IM
- Keywords
- Impacted third molar, Dexamethasone, Postoperative pain, Facial swelling, Trismus, Third molar surgery, Oral surgery, Randomized clinical trial
- Medical subject headings
- Pain, Postoperative, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 8 mg IMDrug
Patients receive a single intramuscular injection of 8 mg dexamethasone 30 minutes before surgical removal of impacted mandibular third molars. This intervention is intended to reduce postoperative pain, facial swelling, and trismus. No additional steroids are allowed postoperatively.
Normal Saline IMDrug
Patients receive a single intramuscular injection of 2 mL normal saline 30 minutes before surgical removal of impacted mandibular third molars. This placebo control is used to compare the effect of preoperative dexamethasone on postoperative pain, facial swelling, and trismus.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Group (Treatment) | Experimental | Participants receive a single dose of 8 mg dexamethasone administered intramuscularly 30 minutes before impacted mandibular third molar surgery. This intervention is intended to reduce postoperative pain, facial swelling, and limited jaw opening (trismus). Participants, care providers, investigators, and outcome assessors are blinded to group allocation. Receives: Drug: Dexamethasone 8 mg IM |
| Placebo Group (Control) | Placebo comparator | Participants receive a single dose of normal saline (placebo) administered intramuscularly 30 minutes before impacted mandibular third molar surgery. This arm serves as the control group for comparison with the dexamethasone group. Blinding is maintained for participants, care providers, investigators, and outcome assessors. Receives: Drug: Normal Saline IM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Measured: 6, 24, 48, and 72 hours postoperatively.
Facial Swelling Measured by Linear Facial Measurements (Tragus-Pogonion and Gonion-Lateral Canthus Distances)
Facial swelling will be assessed using standardized linear facial measurements between anatomical landmarks (tragus to pogonion and gonion to lateral canthus) using a flexible measuring tape. Measurements will be recorded in millimeters (mm). An increase in distance compared to preoperative values indicates greater facial swelling.
Measured: Preoperatively, Day 2, and Day 7 postoperatively
Trismus (Maximum interincisal opening)
Trismus will be measured by maximum interincisal mouth opening using calipers.
Measured: Preoperatively, Day 2, and Day 7 postoperatively
Secondary outcomes (2)
Analgesic consumption
Total number of rescue analgesic tablets (ibuprofen 400 mg) taken postoperatively.
Measured: Postoperative days 1-7
Number of rescue analgesic tablets taken
Number of additional analgesic tablets consumed by each participant after surgery.
Measured: Postoperative days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start4 Jan 2026
- Primary completion4 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third MolarStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to receive either preoperative intramuscular dexamethasone or placebo before impacted mandibular third molar surgery, and outcomes are compared between both groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Salam University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omaima M Sakr, BDS, MSc, PhD, Principal investigator, Al Salam University, Faculty of Oral & Dental Medicine, EgyptAhmed K Fawzi, BDS, MSc, PhD, Study director, Al Salam University, Faculty of Oral & Dental Medicine, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450638
- Sponsor's protocol ID
- Sue010401262
- Other IDs
- Sue010401262
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared outside the study team due to privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Long-acting Corticosteroids on Postoperative Pain, Swelling, and Trismus Following Impacted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07450638
- Acronym / sponsor ID
- Sue010401262
- Keywords
- Impacted third molar, Dexamethasone, Postoperative pain, Facial swelling, Trismus, Third molar surgery, Oral surgery, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al Salam UniversityUniversity, hospital or other
- Study start
- 4 Jan 2026 (actual)
- Primary completion
- 4 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 5 Mar 2026 (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 study evaluated whether giving a single dose of long-acting corticosteroids before wisdom tooth surgery reduces pain, facial swelling, and limited jaw opening (trismus) after surgery. Adult patients aged 18-35 undergoing impacted lower wisdom tooth removal were randomly assigned to receive either 8 mg dexamethasone or a placebo before surgery. Pain, swelling, and jaw mobility were measured at several time points after surgery. The study aimed to determine if preoperative corticosteroids improve recovery and reduce discomfort following surgery.
Detailed description
Surgical removal of impacted lower wisdom teeth often causes pain, swelling, and reduced jaw opening (trismus) due to tissue inflammation. This study examined whether giving a single dose of long-acting corticosteroids before surgery could reduce these postoperative problems.
Adult patients aged 18-35 years who required surgical extraction of impacted mandibular third molars were randomly assigned to receive either 8 mg dexamethasone (treatment group) or a placebo (control group) 30 minutes before surgery. The study measured pain using a visual analog scale, facial swelling with standard facial landmarks, and jaw opening with calipers at multiple time points after surgery. Analgesic consumption was also recorded.
The goal was to determine whether preoperative corticosteroid administration could improve recovery, reduce discomfort, and enhance patient comfort after third molar surgery. This information may help guide oral surgeons in postoperative care and improve outcomes for patients undergoing similar procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to receive either preoperative intramuscular dexamethasone or placebo before impacted mandibular third molar surgery, and outcomes are compared between both groups.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Group (Treatment) | Experimental | Drug: Dexamethasone 8 mg IMParticipants receive a single dose of 8 mg dexamethasone administered intramuscularly 30 minutes before impacted mandibular third molar surgery. This intervention is intended to reduce postoperative pain, facial swelling, and limited jaw opening (trismus). Participants, care providers, investigators, and outcome assessors are blinded to group allocation. |
| Placebo Group (Control) | Placebo comparator | Drug: Normal Saline IMParticipants receive a single dose of normal saline (placebo) administered intramuscularly 30 minutes before impacted mandibular third molar surgery. This arm serves as the control group for comparison with the dexamethasone group. Blinding is maintained for participants, care providers, investigators, and outcome assessors. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-35 years
- Indicated for surgical removal of impacted mandibular third molars (Pell \& Gregory Class II-III)
- ASA I or II (healthy or mild systemic disease)
- Willing to provide informed consent
Key exclusion criteria (5 listed)
- Known allergy to corticosteroids
- Systemic diseases contraindicating steroid use (e.g., uncontrolled diabetes, immunosuppression)
- Pregnancy or lactation
- Acute pericoronitis or local infection
- Current use of steroids or NSAIDs
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 8 mg IMPatients receive a single intramuscular injection of 8 mg dexamethasone 30 minutes before surgical removal of impacted mandibular third molars. This intervention is intended to reduce postoperative pain, facial swelling, and trismus. No additional steroids are allowed postoperatively. | Drug | Dexamethasone Group (Treatment) |
| Normal Saline IMPatients receive a single intramuscular injection of 2 mL normal saline 30 minutes before surgical removal of impacted mandibular third molars. This placebo control is used to compare the effect of preoperative dexamethasone on postoperative pain, facial swelling, and trismus. | Drug | Placebo Group (Control) |
Primary outcome
Postoperative pain
Time frame: 6, 24, 48, and 72 hours postoperatively.
Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Facial Swelling Measured by Linear Facial Measurements (Tragus-Pogonion and Gonion-Lateral Canthus Distances)
Time frame: Preoperatively, Day 2, and Day 7 postoperatively
Facial swelling will be assessed using standardized linear facial measurements between anatomical landmarks (tragus to pogonion and gonion to lateral canthus) using a flexible measuring tape. Measurements will be recorded in millimeters (mm). An increase in distance compared to preoperative values indicates greater facial swelling.
Trismus (Maximum interincisal opening)
Time frame: Preoperatively, Day 2, and Day 7 postoperatively
Trismus will be measured by maximum interincisal mouth opening using calipers.
2 secondary outcomes
Analgesic consumption
Time frame: Postoperative days 1-7
Number of rescue analgesic tablets taken
Time frame: Postoperative days 1-7
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 5 Mar 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared outside the study team due to privacy and confidentiality considerations.
Related trials for Impacted Mandibular Third Molar
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect
Not yet recruiting
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
Impacted Third Molar Tooth, Surgical Wound Healing
Active, not recruiting
Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery
Facial Swelling, Tooth Position Anomalies
Recruiting
Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
Alveolar Bone Loss
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. This study is not recruiting at the moment.
Omaima M Sakr, BDS, MSc, PhD principal investigator
Al Salam University, Faculty of Oral & Dental Medicine, Egypt
Ahmed K Fawzi, BDS, MSc, PhD study director
Al Salam University, Faculty of Oral & Dental Medicine, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone 8 mg IM and Normal Saline IM in people with Impacted Mandibular Third Molar and Postoperative Pain, run by Al Salam University at 1 site in Egypt.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. 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 Egypt. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 6, 24, 48, and 72 hours postoperatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.