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"Effect of Preoperative Submucosal Dexamethasone on Postoperative Discomfort After Mandibular Third Molar Surgery"

Effect of Preoperative 4 mg Submucosal Dexamethasone on Postoperative Discomfort After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07554963
Acronym
DEXA-M3M
Enrollment
268
Registered
2026-04-28
Start date
2026-05-01
Completion date
2026-10-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted Mandibular Third Molar, Postoperative Pain, Trismus

Keywords

Dexamethasone, Third Molar Surgery, Impacted Tooth, Postoperative Pain

Brief 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. 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.

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.

Interventions

DRUGDexamethasone

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.

OTHERNo intervention

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.

Sponsors

Hayat Abad Medical Complex, Peshawar
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

This study is conducted as an open-label trial. No blinding is applied to participants, care providers, investigators, or outcome assessors due to the nature of the intervention (submucosal injection versus no intervention).

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Adults aged 18 to 55 years * Patients requiring surgical extraction of impacted mandibular third molars * Patients willing to provide informed consent

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Assessed by Visual Analogue Scale (VAS)Postoperative Days 2 and 7Pain 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.

Contacts

CONTACTAbdul Basit Khan, FCPS I
drbasitkhan7@gmail.com+92 318 6809664

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026