Effects of Hyaluronic Acid Complex and Dexamethasone on Pain, Swelling, and Trismus After Mandibular Third Molar Surgery

NCT07853196 | Completed

• 1 other identifier: KSTU//2026/009
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to comparatively evaluate the effects of a hyaluronic acid complex and dexamethasone on postoperative pain, swelling, and trismus following mandibular third molar surgery, compared with a control group. Participants were evaluated in three groups: a hyaluronic acid complex group, a dexamethasone group, and a control group. Postoperative pain, facial swelling, and limitation of mouth opening were assessed during the postoperative follow-up period to compare postoperative outcomes among the groups.

Conditions

Postoperative Morbidity Following Mandibular Third Molar Surgery

Keywords

Mandibular Third Molar Surgery Hyaluronic Acid Dexamethasone Postoperative Pain Facial Swelling Trismus

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain Assessed Using the Visual Analog Scale (VAS)

  Postoperative pain was assessed using a patient-reported Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicated no pain and 10 indicated unbearable/worst pain. Participants indicated their perceived pain intensity on the scale. No preoperative VAS measurement was performed

  Postoperative days 1, 2, 3, and 7

• Facial Swelling Assessed Using Facial Measurements

  Facial swelling was assessed in millimeters (mm) using a flexible measuring tape. Three anatomical distances were measured: tragus to labial commissure, tragus to pogonion, and mandibular angle to lateral canthus. The arithmetic mean of the three measurements was calculated for each participant. Postoperative percentage change from the preoperative baseline was calculated as \[(postoperative mean - preoperative mean) / \|preoperative mean\|\] × 100. Positive values indicated an increase in facial measurements.

  Preoperatively and on postoperative days 1, 2, 3, and 7

• Trismus Assessed by Maximum Interincisal Mouth Opening

  Trismus was assessed by measuring maximum interincisal mouth opening in millimeters (mm) using a digital caliper. The distance between the incisal edges of the maxillary and mandibular central incisors was measured once at each assessment. Postoperative percentage change from the preoperative baseline was calculated as \[(postoperative value - preoperative value) / \|preoperative value\|\] × 100. Negative values indicated a reduction in maximum mouth opening.

  Preoperatively and on postoperative days 1, 2, 3, and 7

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Following mandibular third molar extraction, SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge (MS0005; 1 × 1 × 1 cm; Ethicon, Johnson \& Johnson) was placed into the extraction socket. No hyaluronic acid complex or dexamethasone was administered. The surgical site was primarily closed with 3/0 silk sutures, which were removed on postoperative day 7.

Device: Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental)

Hyaluronic Acid Complex Group

EXPERIMENTAL

Following mandibular third molar extraction, 0.2 mL of Monovisc® (22 mg/mL cross-linked high-molecular-weight sodium hyaluronate; Anika Therapeutics, Inc., Bedford, MA, USA), corresponding to 4.4 mg of sodium hyaluronate, was applied directly into the extraction socket. SPONGOSTAN™ Dental was subsequently placed to enhance retention within the socket. The surgical site was primarily closed with 3/0 silk sutures, which were removed on postoperative day 7.

Drug: Hyaluronic Acid Complex; Device: Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental)

Dexamethasone Group

EXPERIMENTAL

Following mandibular third molar extraction, 1.5 mL of DEKORT® 8 mg/2 mL I.M./I.V. solution for injection (DEVA Holding A.Ş., Türkiye), corresponding to 6 mg of dexamethasone, was absorbed into SPONGOSTAN™ Dental and placed into the extraction socket. The surgical site was primarily closed with 3/0 silk sutures, which were removed on postoperative day 7.

Drug: Dexamethasone; Device: Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental)

Interventions

Hyaluronic Acid Complex DRUG

Monovisc® (Anika Therapeutics, Inc., Bedford, MA, USA), containing 22 mg/mL cross-linked, high-molecular-weight sodium hyaluronate, was used. A 0.2 mL volume of the preparation (equivalent to 4.4 mg sodium hyaluronate) was applied directly into the extraction socket using a sterile applicator. SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge was subsequently placed into the socket to enhance retention of the preparation.

Hyaluronic Acid Complex Group

Dexamethasone DRUG

DEKORT® 8 mg/2 mL solution for I.M./I.V. injection (DEVA Holding A.Ş., Türkiye) was used. A 1.5 mL volume of the solution, corresponding to 6 mg dexamethasone, was absorbed into a SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge and placed directly into the extraction socket.

Dexamethasone Group

Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental) DEVICE

SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge (MS0005; 1 × 1 × 1 cm; Ethicon, Johnson \& Johnson) was placed directly into the extraction socket. In the control group, the gelatin sponge was used without hyaluronic acid or dexamethasone.

Control Group; Dexamethasone Group; Hyaluronic Acid Complex Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Cyprus Health and Social Sciences University: lead

Study Sites (1)

NEW Cyprus Health and Social Sciences University

Mórfou, Guzelyurt, 99750, Cyprus

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant/PhD Student

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 1, 2026
• Study Start: March 5, 2026
• Primary Completion: July 25, 2026
• Study Completion: July 25, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)