Comparing Methylprednisolone And Hyaluronic Acid To Reduce Wisdom Tooth Surgery Complications

NCT07317596 | Enrolling By Invitation Phase 3 DMC

• 1 other identifier: 742
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess and compare the effectiveness of methylprednisolone and hyaluronic acid (HA), alone and in combination, in managing post-operative complications following the surgical extraction of impacted mandibular third molars (wisdom teeth). It will also learn about the safety and side effects of these treatments. The main questions it aims to answer are:

• How effectively does methylprednisolone reduce post-operative pain, swelling (edema), and limited mouth opening (trismus)?
• How effectively does hyaluronic acid reduce post-operative pain, swelling (edema), and limited mouth opening (trismus)?
• Is the combination of methylprednisolone and hyaluronic acid more effective than either treatment alone in controlling these post-operative complications?
• What complications (e.g., soft tissue issues, infection) do participants experience with each treatment group? Researchers will compare the effects of methylprednisolone (given intravenously before surgery), hyaluronic acid (placed in the tooth socket after extraction), and a combination of both, against a control group that receives standard care (saline irrigation) to see which treatment or combination is most effective. Participants will be medically healthy adults between the ages of 18 and 40 who are undergoing the surgical extraction of a fully impacted mandibular third molar. Participants will be randomly assigned to one of four groups:
• Group I (Control): Receive standard care (saline irrigation of the wound).
• Group II (Methylprednisolone): Receive a single 125 mg dose of methylprednisolone intravenously one hour before surgery.
• Group III (Hyaluronic Acid): Receive 2 ml of hyaluronic acid placed directly into the tooth socket after extraction.
• Group IV (Combination): Receive both the pre-operative methylprednisolone injection and the post-extraction hyaluronic acid in the socket. All participants will receive standard post-operative care, including antibiotics and pain medication, and will be followed up periodically to monitor for complications such as soft tissue issues or infection.

Conditions

Hyaluronic Acid; Methylprednisolone; Wisdom Tooth Removal; Post Operative Complications

Keywords

Mandibular third molar; Surgical extraction; Complications; Efficacy; Hyaluronic acid; Methylprednisolone

Outcome Measures

Primary Outcomes (1)

• Comparison of Post-operative Complications (Pain, Swelling, and Trismus

  Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.

Secondary Outcomes (3)

• Change in Maximum Interincisal Opening (MIO)

  Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours and 7 days post-surgery.

• Change in Facial Swelling in Millimeters (Anthropometric Measurement).

  Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery

• Incidence of Post-operative Adverse Events.

  Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.

Study Arms (4)

Control group

NO INTERVENTION

The control group will receive neither hyaluronic acid nor methylprednisolone

Hyaluronic acid only

EXPERIMENTAL

Hyaluronic acid placement only

Biological: Hyaluronic Acid (HA)

Methylprednisolone only

EXPERIMENTAL

Methylprednisolone injection only

Drug: Methyl Prednisolone (MP)

Combination

EXPERIMENTAL

Methylprednisolone + Hyaluronic acid

Drug: Methyl Prednisolone (MP); Biological: Hyaluronic Acid (HA)

Interventions

Hyaluronic Acid (HA) BIOLOGICAL

Hyaluronic acid (HA) is a naturally occurring glycosaminoglycan that is placed directly into the tooth socket after the surgical extraction of the impacted mandibular third molar. A volume of 2 ml of HA is applied before the surgical site is closed. This intervention is intended to promote tissue healing, reduce inflammation, and aid in the control of post-operative pain and swelling.

Also known as: Sodium Hyaluronate

Combination; Hyaluronic acid only

Methyl Prednisolone (MP) DRUG

Methylprednisolone sodium succinate is a synthetic glucocorticoid (corticosteroid) administered intravenously at a single dose of 125 mg one hour prior to the surgical extraction of the impacted mandibular third molar. The purpose of this intervention is to reduce the inflammatory response, thereby controlling post-operative complications such as pain, swelling (edema), and limited mouth opening (trismus).

Also known as: Methylprednisolone sodium succinate

Combination; Methylprednisolone only

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient medically healthy.
• Patient between the ages of 18 and 40
• Patient had impacted mandibular third molar indication for extraction( mesio angler full impaction)
• Patients who were cooperative, motivated, to attend the follow-up

You may not qualify if:

• Pregnant women, children, elderly (\>40 years), physically and mentally challenged, terminally and seriously ill.
• Patients who had severe pericoronitis, concomitant carious and/or periodontal disease.
• Patient who had contraindications to the medicines or anesthetics.
• Uncooperative Patients who won't be able to maintain the follow up visits.

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (1)

Sana'a University

Sanaa, 0000, Yemen

Location

Related Publications (3)

• Blondeau F, Daniel NG. Extraction of impacted mandibular third molars: postoperative complications and their risk factors. J Can Dent Assoc. 2007 May;73(4):325.

  PMID: 17484797 BACKGROUND

• Altaweel AA, Gaber AE, Alnaffar MZ, Alshomrani EA, Alrehaili RA, Alshaikh RA, Baeshin JN, Al-Akhdar ES. Methylprednisolone and Hyaluronic Acid versus Each Agent Alone to Control Complication of Impacted Wisdom Removal. Evid Based Complement Alternat Med. 2022 Mar 24;2022:1563513. doi: 10.1155/2022/1563513. eCollection 2022.

  PMID: 35368756 BACKGROUND

• Alenazi A, Alqhtani NR, Alghannam SS, Alghanim AM, Alasmari M, Almalki S, Eid MK. Effect of Hyaluronic Acid on Socket Healing After Lower Impacted Third Molar Tooth Extraction in 40 Dental Patients. Med Sci Monit. 2024 Sep 16;30:e945386. doi: 10.12659/MSM.945386.

  PMID: 39279207 BACKGROUND

MeSH Terms

Interventions

Methylprednisolone Hemisuccinate; Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Amal Y Al-Eryani

  Sana'a University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maxillofacial Surgeon

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: June 27, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)