Impacted Mandibular Third Molar ExtractionPhase 4NCT07258498
Submucosal Dexamethasone for Control of Post-operative Pain, Trismus, and Swelling After Mandibular Third Molar Surgery
A Phase 4 study testing Dexamethasone and Normal Saline in people with Impacted Mandibular Third Molar Extraction, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
Trial summary
Purpose: The aim of this study is to determine the efficacy of submucosal injection of dexamethasone in reducing pain, swelling and trismus, thus to minimize patient's discomfort after surgery, so that the patients could pursue their daily activities without delay. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Impacted Mandibular Third Molar Extraction
- What is being tested?
- Dexamethasone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to 30 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cases of impacted mandibular third molar according to Pell and Gregory classification (class l, 2. 3 and A. B, C)
- Both genders (male and female)
- Age limit: 18 - 45 years
Who cannot join
- Patients with pericoronitis.
- Patients with known allergy to corticosteroids.
- Medically compromised patients.
- Current pregnancy.
- Lactating women.
- Use of medication by the patients that could interfere with the healing process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Submucosal Injection of Dexamethasone for the Control of Post-operative Sequelae After Mandibular Third Molar Surgery
Purpose: The aim of this study is to determine the efficacy of submucosal injection of dexamethasone in reducing pain, swelling and trismus, thus to minimize patient's discomfort after surgery, so that the patients could pursue their daily activities without delay. Moreover, the submucosal injection is convenient to the patient and surgeon both, as it is injected after application of local anesthesia and easily administered. OBJECTIVES: To evaluate the outcome of submucosal injection of 4mg/ml dexamethasone in comparison with submucosal injection of normal saline (N/S) on mean post-operative pain, trismus and swelling following mandibular third molar surgery.
Read the detailed description
OPERATIONAL DEFINITIONS:
Pain: Post-operative pain outcome when measured using Visual Analogue Scale (VAS) would determine the subjective pain experience of patients. VAS is a straight, 10 cm long horizontal line. VAS represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicate their level of pain (in cm) by marking a single point on the line.
Swelling: Post-operative facial swelling would be assessed by using Gabka and Matsumara technique. Linear distance between angle of the mandible to lateral corner of the eye (A), distance between tragus to corner of the mouth (B), and distance between tragus to soft tissue pogonion (C) would be quantified in millimeters using measuring tape. The sum of these measurements would be calculated as facial dimension and used to measure the level of swelling in millimeters.
Trismus: Trismus i.e., reduced mouth opening would be quantified in millimeters by measuring interincisal distance at maximum mouth opening using a vernier caliper. Normal mouth opening ranges from 40 to 60 mm. Mouth opening less than 40 mm is considered trismus.
HYPOTHESIS:
Submucosal injection of 4mg/ml dexamethasone will result in lower mean postoperative pain, reduced trismus and less swelling after mandibular third molar surgery.
- Being tested
- Dexamethasone, Normal Saline
- Keywords
- submucosal dexamethasone, impacted mandibular third molar, surgical extraction, pain, swelling, trismus
- Medical subject headings
- Pain, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
In this study submucosal injection of dexamethasone would be given to the patient 30 minutes before surgical extraction of impacted mandibular third molar surgery to reduce pain, swelling and trismus, thus to minimize patient's discomfort after surgery, so that the patients could pursue their daily activities without delay
Normal SalineDrug
submucosal injection of normal saline (N/S) would not reduce trismus, swelling, and pain
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | submucosal injection of dexamethasone would be used in this study to prevent post-operative pain , swelling and trismus in patient having surgical extraction of impacted mandibular third molars. Receives: Drug: Dexamethasone |
| Normal saline (placebo) | Placebo comparator | Out of 70 patients 35 patients would be given submucosal injection of normal saline as a placebo. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of post-operative pain, in patients who have undergone surgery for impacted mandibular third molars.
Pain: Post-operative pain outcome when measured using Visual Analogue Scale (VAS) would determine the subjective pain experience of patients. VAS is a straight, 10 cm long horizontal line. VAS represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicate their level of pain (in cm). by marking a single point on the line.
Measured: from enrolment to 7th post operative day
measurement of post-operative trismus in patients who have undergone surgery for impacted mandibular third molars.
Trismus i.e., reduced mouth opening would be quantified in millimeters by measuring interincisal distance at maximum mouth opening using a vernier caliper. Normal mouth opening ranges from 40 to 60 mm. Mouth opening less than 40 mm is considered trismus.
Measured: From enrollment to the 7th Postoperative day
measurement of post-operative swelling in patients who have undergone surgery for impacted mandibular third molars.
Swelling: Post-operative facial swelling would be assessed by using Gabka and Matsumara technique. Linear distance between angle of the mandible to lateral corner of the eye (A), distance between tragus to corner of the mouth (B), and distance between tragus to soft tissue pogonion (C) would be quantified in millimeters using measuring tape. The sum of these measurements would be calculated as facial dimension and used to measure the level of swelling in millimeters.
Measured: from enrolment to 7th post operative day
Secondary outcomes (3)
demographic data (name, age, gender)
name, age, gender would be used to assess the effects of demographic data on post operative sequelae
Measured: from enrolment to 7th post operative day
tooth number of impacted tooth according to FDI tooth numbering system, type of impaction
tooth number of impacted tooth according to FDI tooth numbering system, type of impaction according to pell and gregory classification would be used to assess any effect of these outcomes on post-operative sequelae after mandibular third molar surgery.
Measured: from enrolment to 7th post operative day
No. of Paracetamol 500 mg tablets taken orally postoperatively
No. of Paracetamol 500 mg tablets taken orally postoperatively would be used to assess if patient was pain free or had pain post-operatively following impacted mandibular third molar surgery.
Measured: from enrolment to 7th post operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Oct 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third Molar ExtractionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study design: Randomized controlled trial (RCT). Setting: Department of Oral \& Maxillofacial Surgery, Pakistan Atomic Energy Commission General Hospital, Islamabad. Duration: 12 months (after approval of synopsis from CPSP)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- PAEC General Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kanza Ateeque, PAEC General Hospital, Islamabad
- Investigators
- Dr Kanza Ateeque, BDS, Principal investigator, PAEC General Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258498
- Sponsor's protocol ID
- PGHI-IRB (DMe)-RCD-06-068
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the hospital where this study is being conducted does allow to share any collected data with other researchers due to patient confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submucosal Injection of Dexamethasone for the Control of Post-operative Sequelae After Mandibular Third Molar Surgery
- ClinicalTrials.gov ID
- NCT07258498
- Acronym / sponsor ID
- PGHI-IRB (DMe)-RCD-06-068
- Keywords
- submucosal dexamethasone, impacted mandibular third molar, surgical extraction, pain, swelling, trismus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- PAEC General Hospital, IslamabadUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 2 Dec 2025 (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.
Purpose: The aim of this study is to determine the efficacy of submucosal injection of dexamethasone in reducing pain, swelling and trismus, thus to minimize patient's discomfort after surgery, so that the patients could pursue their daily activities without delay. Moreover, the submucosal injection is convenient to the patient and surgeon both, as it is injected after application of local anesthesia and easily administered. OBJECTIVES: To evaluate the outcome of submucosal injection of 4mg/ml dexamethasone in comparison with submucosal injection of normal saline (N/S) on mean post-operative pain, trismus and swelling following mandibular third molar surgery.
Detailed description
OPERATIONAL DEFINITIONS:
Pain: Post-operative pain outcome when measured using Visual Analogue Scale (VAS) would determine the subjective pain experience of patients. VAS is a straight, 10 cm long horizontal line. VAS represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicate their level of pain (in cm) by marking a single point on the line.
Swelling: Post-operative facial swelling would be assessed by using Gabka and Matsumara technique. Linear distance between angle of the mandible to lateral corner of the eye (A), distance between tragus to corner of the mouth (B), and distance between tragus to soft tissue pogonion (C) would be quantified in millimeters using measuring tape. The sum of these measurements would be calculated as facial dimension and used to measure the level of swelling in millimeters.
Trismus: Trismus i.e., reduced mouth opening would be quantified in millimeters by measuring interincisal distance at maximum mouth opening using a vernier caliper. Normal mouth opening ranges from 40 to 60 mm. Mouth opening less than 40 mm is considered trismus.
HYPOTHESIS:
Submucosal injection of 4mg/ml dexamethasone will result in lower mean postoperative pain, reduced trismus and less swelling after mandibular third molar surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Study design: Randomized controlled trial (RCT). Setting: Department of Oral \& Maxillofacial Surgery, Pakistan Atomic Energy Commission General Hospital, Islamabad. Duration: 12 months (after approval of synopsis from CPSP)
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasonesubmucosal injection of dexamethasone would be used in this study to prevent post-operative pain , swelling and trismus in patient having surgical extraction of impacted mandibular third molars. |
| Normal saline (placebo) | Placebo comparator | Drug: Normal SalineOut of 70 patients 35 patients would be given submucosal injection of normal saline as a placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cases of impacted mandibular third molar according to Pell and Gregory classification (class l, 2. 3 and A. B, C)
- Both genders (male and female)
- Age limit: 18 - 45 years
Key exclusion criteria (6 listed)
- Patients with pericoronitis.
- Patients with known allergy to corticosteroids.
- Medically compromised patients.
- Current pregnancy.
- Lactating women.
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 |
|---|---|---|
| DexamethasoneIn this study submucosal injection of dexamethasone would be given to the patient 30 minutes before surgical extraction of impacted mandibular third molar surgery to reduce pain, swelling and trismus, thus to minimize patient's discomfort after surgery, so that the patients could pursue their daily activities without delay | Drug | Dexamethasone |
| Normal Salinesubmucosal injection of normal saline (N/S) would not reduce trismus, swelling, and pain | Drug | Normal saline (placebo) |
Primary outcome
measurement of post-operative pain, in patients who have undergone surgery for impacted mandibular third molars.
Time frame: from enrolment to 7th post operative day
Pain: Post-operative pain outcome when measured using Visual Analogue Scale (VAS) would determine the subjective pain experience of patients. VAS is a straight, 10 cm long horizontal line. VAS represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicate their level of pain (in cm). by marking a single point on the line.
measurement of post-operative trismus in patients who have undergone surgery for impacted mandibular third molars.
Time frame: From enrollment to the 7th Postoperative day
Trismus i.e., reduced mouth opening would be quantified in millimeters by measuring interincisal distance at maximum mouth opening using a vernier caliper. Normal mouth opening ranges from 40 to 60 mm. Mouth opening less than 40 mm is considered trismus.
measurement of post-operative swelling in patients who have undergone surgery for impacted mandibular third molars.
Time frame: from enrolment to 7th post operative day
Swelling: Post-operative facial swelling would be assessed by using Gabka and Matsumara technique. Linear distance between angle of the mandible to lateral corner of the eye (A), distance between tragus to corner of the mouth (B), and distance between tragus to soft tissue pogonion (C) would be quantified in millimeters using measuring tape. The sum of these measurements would be calculated as facial dimension and used to measure the level of swelling in millimeters.
3 secondary outcomes
demographic data (name, age, gender)
Time frame: from enrolment to 7th post operative day
tooth number of impacted tooth according to FDI tooth numbering system, type of impaction
Time frame: from enrolment to 7th post operative day
No. of Paracetamol 500 mg tablets taken orally postoperatively
Time frame: from enrolment to 7th post operative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. As the hospital where this study is being conducted does allow to share any collected data with other researchers due to patient confidentiality
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Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
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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.
Dr Kanza Ateeque, BDS principal investigator
PAEC General Hospital, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Normal Saline in people with Impacted Mandibular Third Molar Extraction, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 2 Dec 2025. 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
measurement of post-operative pain, in patients who have undergone surgery for impacted mandibular third molars. (time frame: from enrolment to 7th post operative day). 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 2 Dec 2025.