Comparing Methylprednisolone And Hyaluronic Acid To Reduce Wisdom Tooth Surgery Complications

Efficacy of Methylprednisolone and Hyaluronic Acid, Individually and in Combination, on Reducing Postoperative Complications After Mandibular Third Molar Extraction

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Methylprednisolone; Hyaluronic Acid; Post Operative Complications; Wisdom Tooth Removal
• Intervention / Treatment: Biological: Hyaluronic Acid (HA); Drug: Methyl Prednisolone (MP)

Detailed Description

The surgical extraction of impacted mandibular third molars is a common procedure in oral and maxillofacial surgery, frequently associated with considerable postoperative complications such as pain, facial edema, and limited mandibular movement (trismus). Minimizing these adverse effects is crucial for the success of surgical procedures and patient comfort.While various methods are used to reduce these sequelae, adverse effects still pose a major challenge. Corticosteroids, such as methylprednisolone sodium succinate, offer potent anti-inflammatory actions that inhibit vasodilatation and decrease cellular exudates, which helps in reducing postoperative edema and pain. Additionally, Hyaluronic Acid (HA), a biocompatible glycosaminoglycan, plays a critical role in soft tissue structure, demonstrating anti-inflammatory impacts during oral wound healing and supporting tissue integrity.This prospective randomized controlled clinical trial is designed to evaluate and compare the individual and synergistic effectiveness of intravenous methylprednisolone sodium succinate and local application of hyaluronic acid in controlling post-extraction complications. The study will strictly monitor and objectively evaluate clinical outcomes including facial swelling, pain intensity, mouth opening, wound healing, and total analgesic consumption over a 7-day postoperative follow-up period.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Yemen
  • Sanaa, Yemen, 0000
    • Sana'a University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The control group will receive neither hyaluronic acid nor methylprednisolone
Experimental: Hyaluronic acid only; Hyaluronic acid placement only	Biological: Hyaluronic Acid (HA); 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.; Other Names: Sodium Hyaluronate
Experimental: Methylprednisolone only; Methylprednisolone injection only	Drug: Methyl Prednisolone (MP); 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).; Other Names: Methylprednisolone sodium succinate
Experimental: Combination; Methylprednisolone + Hyaluronic acid	Biological: Hyaluronic Acid (HA); 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.; Other Names: Sodium Hyaluronate; Drug: Methyl Prednisolone (MP); 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).; Other Names: Methylprednisolone sodium succinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum Interincisal Opening (MIO)	Mean Change in Maximum Interincisal Opening (MIO) from Baseline to 7 Days Post-surgery. Maximum Interincisal Opening (MIO) is defined as the maximum distance between the incisal edges of the upper and lower central incisors. Measurements will be recorded in millimeters (mm) using a standard surgical ruler. The reported value will be the mean change (decrease or recovery) from the pre-operative baseline measurement at each designated follow-up interval. Unit of Measure: Millimeters (mm).	Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours and 7 days post-surgery.
Incidence of Post-operative Adverse Events.	Number of Participants with Post-operative Adverse Events. This outcome measures the safety and tolerability of the treatment by recording the number of participants who experience any post-operative complications. Adverse events include, but are not limited to: surgical site infection, alveolar osteitis (dry socket), soft tissue dehiscence. Unit of Measure: Number of Participants (Count).	Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.
Change in Facial Swelling in Millimeters (Anthropometric Measurement).	Mean Change in Facial Swelling (Anthropometric Linear Measurements) Mean Change in Facial Swelling Based on the Sum of Two Linear Distances. Facial swelling is assessed using horizontal and vertical linear measurements between four reference points. Facial swelling will be objectively assessed using standardized anthropometric linear measurements (in mm) with a flexible tape or ruler. The total swelling value is calculated as the sum of two distances: From the angle of the mouth (Labial Commissure) to the tragus of the ear. From the external canthus of the eye to the angle of the mandible (Gonion). The reported data will be the mean change in the sum of these two distances compared to the pre-operative baseline. Unit of Measure: Millimeters (mm).	Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery

Collaborators and Investigators

• Sponsor: Sana'a University
• Investigators: Principal Investigator: Amal Y Al-Eryani, Sana'a University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Efficacy; Complications; Methylprednisolone; Hyaluronic acid; Mandibular third molar; Surgical extraction
• Additional Relevant MeSH Terms: Carbohydrates; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Glycosaminoglycans; Polysaccharides; Pregnadienetriols; Methylprednisolone; Prednisolone; Methylprednisolone Hemisuccinate; Hyaluronic Acid
• Other Study ID Numbers: 742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No