Impacted Mandibular Third Molar Extraction, Postoperative Edema and Pain, Postoperative Pain Control
Conditions
Keywords
Mandibular Third Molar Surgery, Impacted Tooth Extraction, Submucosal Dexamethasone, Submucosal Methylprednisolone, Postoperative Pain, Three-Dimensional Facial Analysis, Facial Edema Volumetric Measurement
Brief summary
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).
Detailed description
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.
Interventions
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.
DRUGmethylprednisolone sodium succinate
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.
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.
Sponsors
Irfan Üstündağ
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the absence of a placebo injection in the control group, complete patient and surgeon blinding could not be achieved. However, a single-blind design was rigorously maintained by completely blinding the clinical outcomes assessor, who performed the digital three-dimensional facial scanning superimpositions and volumetric edema data calculations in CloudCompare software, to the group allocations.
Intervention model description
This is a prospective, randomized, controlled, parallel-group clinical trial designed to compare the efficacy of local submucosal injections of dexamethasone versus methylprednisolone on postoperative pain and three-dimensional facial edema following the surgical extraction of fully bone-impacted mandibular third molars. Patients are assigned to one of three parallel arms at a 1:1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Three-Dimensional Facial Edema | Baseline (Preoperative) and Postoperative Day 3 and 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity via Visual Analog Scale | 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". |
| Rescue Analgesic Consumption | Up to 7 days postoperatively | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORirfan ustundag, dr.ogr.uyesi
inonu universitesi
Outcome results
None listed