Comparing Methylprednisolone And Hyaluronic Acid To Reduce Wisdom Tooth Surgery Complications

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-27

Study Completion Date

2026-01-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Wisdom Tooth Removal Post Operative Complications Hyaluronic Acid Methylprednisolone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

The control group will receive neither hyaluronic acid nor methylprednisolone

Group Type NO_INTERVENTION

No interventions assigned to this group

Hyaluronic acid only

Hyaluronic acid placement only

Group Type EXPERIMENTAL

Hyaluronic Acid (HA)

Intervention Type 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.

Methylprednisolone only

Methylprednisolone injection only

Group Type EXPERIMENTAL

Methyl Prednisolone (MP)

Intervention Type 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).

Combination

Methylprednisolone + Hyaluronic acid

Group Type EXPERIMENTAL

Methyl Prednisolone (MP)

Intervention Type 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).

Hyaluronic Acid (HA)

Intervention Type 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.

Interventions

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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).

Intervention Type DRUG

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No