Evaluation of Corticosteroid Administration Following Impacted Third Molar Surgery Using 3-Dimensional Facial Analysis
2026年6月1日 更新者：Irfan Üstündağ
Local Submucosal Dexamethasone Versus Methylprednisolone for Pain and Three-Dimensional Facial Edema After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial
The purpose of this prospective, randomized, controlled, single-blind clinical trial is to compare the efficacy of local submucosal administration of dexamethasone versus methylprednisolone on postoperative morbidity following impacted lower third molar surgery.
The study evaluates postoperative pain using the Visual Analog Scale (VAS) and quantifies three-dimensional facial edema using a mobile smartphone-based scanning workflow (Qlone aligned in CloudCompare).
Patients requiring unilateral extraction of fully bone-impacted mandibular third molars are randomly allocated into three parallel groups: Control (no injection), Methylprednisolone (40 mg), and Dexamethasone (8 mg).
研究概览
地位
完全的
详细说明
Surgical extraction of impacted mandibular third molars routinely induces significant inflammatory sequelae, including pain, edema, and trismus, which substantially impair patient quality of life.
Although local submucosal corticosteroid delivery is a well-established adjunctive approach to minimize postoperative discomfort, head-to-head volumetric comparisons using three-dimensional facial analysis workflows remain limited.
This clinical trial implements a rigorous parallel design to isolate the anti-inflammatory efficacy of two widely utilized corticosteroids.
Following a standardized surgical osteotomy and tooth removal performed by a single experienced surgeon, participants receive either a standardized 2 mL submucosal injection of 40 mg methylprednisolone sodium succinate, 8 mg dexamethasone sodium phosphate, or no injection at the distobuccal aspect of the adjacent second molar.
Three-dimensional digital surface models are acquired preoperatively and longitudinally on postoperative days 3 and 7 to evaluate precise volumetric facial changes.
Concurrently, subjective patient-reported pain kinetics are systematically dökümante edilmiştir via regular VAS recordings.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Malatya
-
Malatya、Malatya、土耳其（türkiye）、44050
- Inonu University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
-
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
1. Systemically healthy individuals classified as ASA I according to the American Society of Anesthesiologists.
2. Patients between 18 and 35 years of age. 3. Presence of a unilateral, fully bone-impacted mandibular third molar with an indication for surgical extraction.
4. Impacted teeth classified as Class II or III and Position B or C according to the Pell-Gregory classification system.
5. Impacted teeth with mesioangular or vertical angulation based on Winter's classification.
6. A moderate surgical difficulty level (score of 5 to 7) confirmed via the Pederson difficulty index.
7. Competency to provide written informed consent and willingness to adhere to follow-up schedules.
Exclusion Criteria:
1. Presence of any systemic disease or medical condition that contraindicates the use of systemic or local corticosteroids.
2. Pregnancy or lactation. 3. Active pericoronitis, acute infection, or pathology (e.g., cysts, tumors) associated with the target third molar or adjacent structures.
4. Use of antibiotics, systemic corticosteroids, or regular anti-inflammatory medications within the past 30 days prior to surgery.
5. History of daily tobacco smoking within the past 6 months. 6. Known allergy or hypersensitivity to local anesthetics, dexamethasone, methylprednisolone, or the prescribed postoperative medications (amoxicillin, clavulanic acid, paracetamol, dexketoprofen).
7. Inability to comply with the 3D facial scanning protocols or postoperative follow-up appointments.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1: Control Group
Patients in this arm undergo the standardized surgical extraction of a fully bone-impacted mandibular third molar under local anesthesia.
No local pharmacological adjuncts, sham injections, or submucosal applications of any corticosteroid or alternative therapeutic agents are administered following the completion of the tooth extraction and surgical debridement.
|
All patients in the study undergo a standardized surgical removal of a fully bone-impacted lower third molar performed by a single experienced surgeon.
Under general anesthesia, a triangular flap is elevated, followed by conservative osteotomy and tooth division using rotary instruments under continuous sterile saline irrigation.
After tooth delivery, the socket is thoroughly debrided, irrigated, and closed primarily using 3-0 silk sutures.
其他名称：
|
|
有源比较器：Group 2: Methylprednisolone Group
Following the standardized surgical extraction of the impacted mandibular third molar, patients in this arm receive a local submucosal injection of 40 mg methylprednisolone sodium succinate (Prednol-L).
The drug is reconstituted with its specific solvent to a final volume of 2 mL and slowly delivered directly into the adjacent mandibular mucobuccal fold.
|
All patients in the study undergo a standardized surgical removal of a fully bone-impacted lower third molar performed by a single experienced surgeon.
Under general anesthesia, a triangular flap is elevated, followed by conservative osteotomy and tooth division using rotary instruments under continuous sterile saline irrigation.
After tooth delivery, the socket is thoroughly debrided, irrigated, and closed primarily using 3-0 silk sutures.
其他名称：
Immediately following the completion of the tooth extraction and before structural flap closure, a single local dose of 40 mg methylprednisolone sodium succinate is administered.
The lyophilized powder is reconstituted with its commercial solvent to a final volume of 2 mL and injected slowly into the adjacent submucosal mucobuccal fold.
其他名称：
|
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有源比较器：Group 3: Dexamethasone Group
Following the standardized surgical extraction of the impacted mandibular third molar, patients in this arm receive a local submucosal injection of 8 mg/2 mL dexamethasone sodium phosphate (Dekort).
The commercial solution is administered slowly in its ready-to-use form directly into the adjacent mucobuccal fold.
|
All patients in the study undergo a standardized surgical removal of a fully bone-impacted lower third molar performed by a single experienced surgeon.
Under general anesthesia, a triangular flap is elevated, followed by conservative osteotomy and tooth division using rotary instruments under continuous sterile saline irrigation.
After tooth delivery, the socket is thoroughly debrided, irrigated, and closed primarily using 3-0 silk sutures.
其他名称：
Immediately following the completion of the tooth extraction and before structural flap closure, a single local dose of 8 mg/2 mL dexamethasone sodium phosphate is administered.
The ready-to-use commercial solution is injected slowly directly into the adjacent submucosal mucobuccal fold.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Three-Dimensional Facial Edema
大体时间：Baseline (Preoperative) and Postoperative Day 3 and 7
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Volumetric soft tissue swelling on the operated side is quantified in cubic millimeters (mm³).
Facial edema is calculated via digital superimposition and surface alignment of Qlone mobile 3D scans in CloudCompare software using the root mean square (RMS) method relative to the baseline scan.
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Baseline (Preoperative) and Postoperative Day 3 and 7
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative Pain Intensity via Visual Analog Scale
大体时间：Postoperative Days 1, 3, and 7
|
Patient-reported subjective pain intensity scored on a standard 10-cm horizontal Visual Analog Scale (VAS), where 0 centimeters indicates "no pain" and 10 centimeters indicates "unbearable/worst imaginable pain".
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Postoperative Days 1, 3, and 7
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Rescue Analgesic Consumption
大体时间：Up to 7 days postoperatively
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The total number of rescue analgesic tablets (25 mg dexketoprofen trometamol) consumed by each participant for breakthrough postoperative pain management during the follow-up period.
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Up to 7 days postoperatively
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：irfan ustundag, dr.ogr.uyesi、inonu universitesi
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ngeow WC, Lim D. Do Corticosteroids Still Have a Role in the Management of Third Molar Surgery? Adv Ther. 2016 Jul;33(7):1105-39. doi: 10.1007/s12325-016-0357-y. Epub 2016 Jun 10.
- Lim D, Ngeow WC. A Comparative Study on the Efficacy of Submucosal Injection of Dexamethasone Versus Methylprednisolone in Reducing Postoperative Sequelae After Third Molar Surgery. J Oral Maxillofac Surg. 2017 Nov;75(11):2278-2286. doi: 10.1016/j.joms.2017.05.033. Epub 2017 Jun 8.
- Fernandez-Martin U, Lisbona-Gonzalez MJ, Vallecillo-Rivas M, Mallo-Magarinos M, Herrera-Briones FJ. Effect of Preoperative Administration of Dexamethasone vs. Methylprednisolone in Surgical Extraction of Impacted Lower Third Molars: Randomized Controlled Clinical Trial. J Clin Med. 2024 Aug 7;13(16):4614. doi: 10.3390/jcm13164614.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年3月2日
初级完成 (实际的)
2026年4月1日
研究完成 (实际的)
2026年4月9日
研究注册日期
首次提交
2026年6月1日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年6月4日
上次提交的符合 QC 标准的更新
2026年6月1日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 2024-KAEK-08-3D
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified individual participant data underlying the results reported in the final manuscript (including demographic characteristics, baseline surgical parameters, 3D facial volumetric measurements, and pain VAS scores) will be made available to qualified researchers upon reasonable academic request.
IPD 共享时间框架
The data will become available immediately following publication of the final manuscript and will remain accessible for up to 3 years.
IPD 共享访问标准
Data will be accessible to qualified clinical researchers upon submitting a scientifically sound research proposal.
Requests should be directed via email to the corresponding author (dt.irfanustundag@gmail.com) and require a signed data use agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.