Impacted Mandibular Third MolarPhase 4DEXA-M3MNCT07554963
"Effect of Preoperative Submucosal Dexamethasone on Postoperative Discomfort After Mandibular Third Molar Surgery"
A Phase 4 study testing Dexamethasone in people with Impacted Mandibular Third Molar and Postoperative Pain, run by Hayat Abad Medical Complex, Peshawar.
Trial summary
This study aims to determine whether giving a single dose of dexamethasone before surgery can reduce pain and difficulty in opening the mouth after removal of an impacted lower wisdom tooth. Pain and limited mouth opening are common problems after this procedure and can affect eating, speaking, and daily activities. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Impacted Mandibular Third Molar, Postoperative Pain, Trismus
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Oct 2026
- Phase
- Phase 4
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 55 years
- Patients requiring surgical extraction of impacted mandibular third molars
- Patients willing to provide informed consent
Who cannot join
- Patients with systemic diseases
- Patients with periodontal disease
- Pregnant or lactating women
- Patients who have used antibiotics or anti-inflammatory drugs within the past 7 days
- Patients with known hypersensitivity to dexamethasone
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Preoperative 4 mg Submucosal Dexamethasone on Postoperative Discomfort After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial
This study aims to determine whether giving a single dose of dexamethasone before surgery can reduce pain and difficulty in opening the mouth after removal of an impacted lower wisdom tooth. Pain and limited mouth opening are common problems after this procedure and can affect eating, speaking, and daily activities.
A total of 268 patients aged 18 to 55 years who require surgical removal of an impacted mandibular third molar will be included. Participants will be randomly assigned to one of two groups. One group will receive a 4 mg dexamethasone injection under the gum before surgery, while the other group will not receive this medication. All patients will undergo the same surgical procedure and receive standard postoperative care.
Read more
Pain will be measured using a visual analogue scale, and mouth opening will be assessed using a standard measuring method. These outcomes will be recorded on the second and seventh days after surgery.
The results of this study will help determine whether preoperative dexamethasone is an effective and simple method to reduce postoperative discomfort and improve recovery after third molar surgery.
Read the detailed description
This randomized controlled trial is designed to evaluate the efficacy of a single preoperative 4 mg submucosal dexamethasone injection in reducing postoperative discomfort following surgical removal of impacted mandibular third molars. Postoperative discomfort is defined by two primary components: pain intensity and degree of trismus.
The study will be conducted at the Department of Oral and Maxillofacial Surgery, MTI-Hayatabad Medical Complex, Peshawar, Pakistan. A total of 268 participants aged 18-55 years requiring surgical extraction of impacted mandibular third molars will be enrolled using non-probability consecutive sampling. Participants with systemic disease, pregnancy, lactation, recent use of antibiotics or anti-inflammatory drugs, or periodontal disease will be excluded.
Eligible participants will be randomly allocated into two equal groups (n=134 each) using a computer-generated randomization method. The intervention group will receive a single 4 mg submucosal injection of dexamethasone at the surgical site following administration of local anesthesia. The control group will undergo the same surgical procedure without administration of dexamethasone.
All procedures will be standardized, including surgical technique (Ward's incision, bone removal, and suturing) and postoperative analgesia (diclofenac 50 mg). No blinding will be performed due to the nature of the intervention.
Pain intensity will be assessed using a 10-cm visual analogue scale (VAS), while trismus will be evaluated by measuring maximum inter-incisal distance (in millimeters) using a vernier caliper. Measurements will be recorded preoperatively and on postoperative days 2 and 7.
Data will be analyzed using SPSS. Continuous variables will be assessed for normality using the Shapiro-Wilk test and expressed as mean ± standard deviation. Between-group comparisons will be performed using independent samples t-test or Mann-Whitney U test, as appropriate. Categorical variables will be expressed as frequencies and percentages and analyzed using chi-square or Fisher's exact test. A p-value ≤0.05 will be considered statistically significant.
This study is expected to provide evidence on the effectiveness of submucosal dexamethasone as a simple, cost-effective intervention to reduce postoperative morbidity following third molar surgery.
- Conditions
- Impacted Mandibular Third Molar, Postoperative Pain, Trismus
- Being tested
- Dexamethasone, No intervention
- Keywords
- Dexamethasone, Third Molar Surgery, Impacted Tooth, Postoperative Pain
- Medical subject headings
- Pain, Postoperative, Trismus, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
A single 4 mg dose of dexamethasone is administered via submucosal injection at the surgical site following local anesthesia prior to extraction of the impacted mandibular third molar.
No interventionOther
Participants do not receive dexamethasone or any study drug. Standard surgical extraction of impacted mandibular third molars is performed, followed by routine postoperative care including analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Group | Experimental | Participants receive a single preoperative 4 mg submucosal injection of dexamethasone at the surgical site following administration of local anesthesia. All patients undergo standardized surgical extraction of impacted mandibular third molars and receive identical postoperative care. Receives: Drug: Dexamethasone; Other: No intervention |
| No Drug Control Group | No intervention | Participants undergo standardized surgical extraction of impacted mandibular third molars without receiving dexamethasone or any study drug. All patients receive identical postoperative care, including analgesia, as per institutional protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Assessed by Visual Analogue Scale (VAS)
Pain intensity will be measured using a 10-cm visual analogue scale (VAS), where 0 indicates no pain and 10 indicates worst possible pain. Scores will be recorded on postoperative day 2 and day 7.
Measured: Postoperative Days 2 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group (preoperative 4 mg submucosal dexamethasone) or the control group (no study drug). Allocation will be performed using a computer-generated randomization sequence. Both groups will undergo the same standardized surgical procedure and receive identical postoperative care. Outcomes will be assessed at predefined time points (postoperative days 2 and 7). The study follows a parallel design in which participants remain in their assigned groups throughout the study period.
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayat Abad Medical Complex, Peshawar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdul Basit Khan, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554963
- Sponsor's protocol ID
- HMC-OMFS-DEXA-2025
- Acronym
- DEXA-M3M
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share individual participant data has not been finalized at this stage. Data sharing will be considered following study completion and publication, subject to institutional policies, ethical considerations, and participant confidentiality safeguards.
Publications
Gaballah K, Eldohaji T, Tannir ME, Shaban R, Habib R, Ali K. Pain control following impacted mandibular third molar surgery: a comparison of the effectiveness of two different protocols. Sci Rep. 2025 Apr 3;15(1):11519. doi: 10.1038/s41598-025-89744-0.
PubMed 40181005Selvido DI, Bhattarai BP, Niyomtham N, Riddhabhaya A, Vongsawan K, Pairuchvej V, Wongsirichat N. Review of dexamethasone administration for management of complications in postoperative third molar surgery. J Korean Assoc Oral Maxillofac Surg. 2021 Oct 31;47(5):341-350. doi: 10.5125/jkaoms.2021.47.5.341.
PubMed 34713808Hou C, Liu F, Liu C. Comparison of Submucosal With Intramuscular or Intravenous Administration of Dexamethasone for Third Molar Surgeries: A Systematic Review and Meta-Analysis. Front Surg. 2021 Aug 10;8:714950. doi: 10.3389/fsurg.2021.714950. eCollection 2021.
PubMed 344477853. Gojayeva N, Pashtayeva N, Nagiyev N, Aliyev A, Özmeriç N, Gülşahı A, et al. Comparison of postoperative pain, swelling, and trismus after impacted mandibular third molar extraction using different cold applications: a randomized controlled clinical trial. BMC Oral Health. 2024;24:131. doi:10.1186/s12903-024-03877-8
Rizqiawan A, Lesmaya YD, Rasyida AZ, Amir MS, Ono S, Kamadjaja DB. Postoperative Complications of Impacted Mandibular Third Molar Extraction Related to Patient's Age and Surgical Difficulty Level: A Cross-Sectional Retrospective Study. Int J Dent. 2022 Jan 3;2022:7239339. doi: 10.1155/2022/7239339. eCollection 2022.
PubMed 35027927Synan W, Stein K. Management of Impacted Third Molars. Oral Maxillofac Surg Clin North Am. 2020 Nov;32(4):519-559. doi: 10.1016/j.coms.2020.07.002. Epub 2020 Sep 9.
PubMed 32919832