Topical Dexamethasone/Diclofenac Hydrogel for Postoperative Pain and Swelling in Facial Soft Tissue Injuries

NCT07853664 | Recruiting Phase 2

• 1 other identifier: EC/FD/2025/014
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, controlled clinical trial will evaluate the clinical effects of a topical thermoresponsive hydrogel containing dexamethasone sodium phosphate and diclofenac sodium on postoperative pain and facial swelling in patients undergoing extraoral maxillofacial surgical procedures or primary closure of clean facial soft tissue wounds. Participants will be stratified according to fracture status and randomly assigned to receive either the active hydrogel or an identical placebo hydrogel. Pain, facial swelling, wound healing, adverse events, patient satisfaction, and rescue analgesic consumption will be evaluated during the postoperative period.

Conditions

Facial Injuries; Pain; Swelling

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Severit

  Assessment of pain intensity using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).

  8 hours, 3 days, and 7 days post-treatment.

• Facial Edema

  Assessment of facial swelling using the Ristow 5-line anatomic measurement method.

  Baseline, 8 hours, 3 days, and 7 days post-treatment.

Study Arms (2)

Pluronic Hydrogel Group

EXPERIMENTAL

Topical application of Pluronic F-127 hydrogel loaded with dexamethasone and diclofenac on facial soft tissue wounds.

Drug: Poloxmer F-127 Hydrogel with Dexamethasone/Diclofenac

Placebo Control Group

ACTIVE COMPARATOR

Topical application of plain Pluronic F-127 hydrogel base without active ingredients (dexamethasone or diclofenac).

Other: Plain Pluronic F-127 Hydrogel Placebo

Interventions

Poloxmer F-127 Hydrogel with Dexamethasone/Diclofenac DRUG

Active topical hydrogel formulation containing dexamethasone and diclofenac for pain and edema control.

Pluronic Hydrogel Group

Plain Pluronic F-127 Hydrogel Placebo OTHER

Blank hydrogel vehicle without active pharmacologic agents.

Placebo Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients undergoing oral and maxillofacial fracture surgeries involving clean surgical incisions .
• Patients presenting with clean oral and maxillofacial soft tissue injuries due to trauma, suitable for primary closure
• ASA class I-II .
• Willing to comply with postoperative follow-up and consent procedures .
• Patients with infected, contaminated, or extensive avulsive wounds .
• Wounds requiring secondary healing or grafting .
• Patients with systemic conditions affecting healing (e.g., diabetes, immunosuppression) .
• Patients with known allergy to DEX or DIC .
• Pregnant or lactating females .
• Patients with chronic steroid or NSAID use .
• Active infections at the surgical site .

Sponsors & Collaborators

• Thamar University: lead

Study Sites (1)

Alwehdah University Teaching Hospital

Dhamar, Yemen

RECRUITING

MeSH Terms

Conditions

Facial Injuries; Pain

Interventions

Dexamethasone; Diclofenac

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Nashwan Hamid Al-Tairi, Associate Professor

  Faculty of Dentistry, Thamar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arshad Mohammed Almansori, BDS

CONTACT

0771697007; arshadalmansori987@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Candidate

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)