Comparing Methylprednisolone And Hyaluronic Acid To Reduce Wisdom Tooth Surgery Complications

Sana'a University

Status and phase: Invitation-only; Phase 3

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07317596

742

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Control group

No Intervention group

Description:

The control group will receive neither hyaluronic acid nor methylprednisolone

Hyaluronic acid only

Experimental group

Description:

Hyaluronic acid placement only

Treatment:

Biological: Hyaluronic Acid (HA)

Methylprednisolone only

Experimental group

Description:

Methylprednisolone injection only

Treatment:

Drug: Methyl Prednisolone (MP)

Combination

Experimental group

Description:

Methylprednisolone + Hyaluronic acid

Treatment:

Biological: Hyaluronic Acid (HA)

Drug: Methyl Prednisolone (MP)