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

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 35 years
• All sexes
• No healthy volunteers
• Adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Comparative Evaluation of the Effects of Hyaluronic Acid Complex and Dexamethasone on Postoperative Pain, Edema, and Trismus Following Mandibular Third Molar Surgery

Conditions

Postoperative Morbidity

Being tested

Hyaluronic Acid Complex, Dexamethasone, Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental)

Keywords

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

Medical subject headings

Pain, Postoperative, Trismus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Hyaluronic Acid ComplexDrug

  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.

• DexamethasoneDrug

  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.

• 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

   Measured: Postoperative days 1, 2, 3, and 7

2. 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.

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

3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted1 Oct 2026
2. Study start5 Mar 2026
3. Primary completion25 Jul 2026
4. Study completion25 Jul 2026

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Postoperative MorbidityStudies 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.