Comparing Methylprednisolone And Hyaluronic Acid To Reduce Wisdom Tooth Surgery Complications

Official title

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

Overview

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.

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.

Interventions

• 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).
• 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.

Primary outcome measures

• Comparison of Post-operative Complications (Pain, Swelling, and Trismus [Time frame: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.]

Secondary outcome measures (3)

• Change in Maximum Interincisal Opening (MIO) [Time frame: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours and 7 days post-surgery.]
• Change in Facial Swelling in Millimeters (Anthropometric Measurement). [Time frame: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery]
• Incidence of Post-operative Adverse Events. [Time frame: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Open label

Primary purpose

Treatment

Study locations

Yemen · 1 center

• Sana'a University — Sanaa

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. PMID 17484797
• 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
• 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

Identifiers

NCT: NCT07317596 · 742

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗