Efficacy of Methylprednisolone and Hyaluronic Acid, Individually and in Combination, on Reducing Postoperative Complications After Mandibular Third Molar Extraction
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparison of Post-operative Complications (Pain, Swelling, and Trismus
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Combination
Methylprednisolone + Hyaluronic acid
干预措施: Hyaluronic Acid (HA) (Biological)
Hyaluronic acid only
Hyaluronic acid placement only
干预措施: Hyaluronic Acid (HA) (Biological)
Combination
Methylprednisolone + Hyaluronic acid
干预措施: Methyl Prednisolone (MP) (Drug)
Methylprednisolone only
Methylprednisolone injection only
干预措施: Methyl Prednisolone (MP) (Drug)
Control group
The control group will receive neither hyaluronic acid nor methylprednisolone
结局指标
主要结局
Comparison of Post-operative Complications (Pain, Swelling, and Trismus
时间窗: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.
次要结局
- Change in Facial Swelling in Millimeters (Anthropometric Measurement).(Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery)
- Change in Maximum Interincisal Opening (MIO)(Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours and 7 days post-surgery.)
- Change in Facial Swelling (Anthropometric Measurement).(Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery)
- Incidence of Post-operative Adverse Events.(Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.)
研究者
Amal Yahya Mohammed Al-Eryani
Maxillofacial Surgeon
Sana'a University