Comparing Methylprednisolone And Hyaluronic Acid To Reduce Wisdom Tooth Surgery Complications

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

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

Interventions

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.

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).

Sponsors & Collaborators

• Sana'a University

  lead OTHER

Principal Investigators

• Amal Y Al-Eryani · Sana'a University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-27

Primary Completion

2026-07-15

Completion

2026-07-15

Countries

• Yemen

Study Locations