A Phase 4 interventional study of Dexamethasone and No intervention in Impacted Mandibular Third Molar, Postoperative Pain and Trismus, sponsored by Hayat Abad Medical Complex, Peshawar. Not yet recruiting. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Hayat Abad Medical Complex, Peshawar · Phase 4, Interventional, and Treatment
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.
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 268 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Hayat Abad Medical Complex, Peshawar is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dexamethasone · Other: 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.
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.
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.
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.
Time frame: Postoperative Days 2 and 7
No study locations are listed for this record.
Plan to share: 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.
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Studies of the drug tested here: Dexamethasone
Hayat Abad Medical Complex, Peshawar