A Phase 3 interventional study of Methyl Prednisolone (MP) and Hyaluronic Acid (HA) in Wisdom Tooth Removal, Post Operative Complications and Hyaluronic Acid, sponsored by Sana'a University. Enrolling by invitation at 1 site in Yemen. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Sana'a University · Phase 3, Interventional, and Treatment
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:
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:
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.
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.
Sana'a University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group will receive neither hyaluronic acid nor methylprednisolone
Hyaluronic acid placement only
Biological: Hyaluronic Acid (HA)
Methylprednisolone injection only
Drug: Methyl Prednisolone (MP)
Methylprednisolone + Hyaluronic acid
Drug: Methyl Prednisolone (MP) · Biological: Hyaluronic Acid (HA)
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).
Also known as: Methylprednisolone sodium succinate
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.
Also known as: Sodium Hyaluronate
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.
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).
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).
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).
Time frame: 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).
Time frame: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.
Plan to share: No
Started Jun 2024 (actual). Primary completion is estimated for Jul 2026, 24 months after the start.
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Studies of the drugs tested here: Methylprednisolone · Hyaluronic Acid
Sana'a University