Impacted Mandibular Third Molar ExtractionNCT07628166
Evaluation of Corticosteroid Administration Following Impacted Third Molar Surgery Using 3-Dimensional Facial Analysis
A study testing Surgical Extraction of Impacted Mandibular Third Molar, methylprednisolone sodium succinate and Dexamethasone Sodium Phosphate Injection in people with Impacted Mandibular Third Molar Extraction and Postoperative Pain Control, run by Irfan Üstündağ at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Mandibular Third Molar Extraction, Postoperative Pain Control, Postoperative Edema and Pain
- What is being tested?
- Surgical Extraction of Impacted Mandibular Third Molar, methylprednisolone sodium succinate and Dexamethasone Sodium Phosphate Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2026to 9 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Malatya, Malatya, 44050
About this study
Official title: 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).
Read the 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.
- Conditions
- Impacted Mandibular Third Molar Extraction, Postoperative Pain Control, Postoperative Edema and Pain
- Being tested
- Surgical Extraction of Impacted Mandibular Third Molar, methylprednisolone sodium succinate, Dexamethasone Sodium Phosphate Injection
- Keywords
- Mandibular Third Molar Surgery, Impacted Tooth Extraction, Submucosal Dexamethasone, Submucosal Methylprednisolone, Postoperative Pain, Three-Dimensional Facial Analysis, Facial Edema Volumetric Measurement
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Extraction of Impacted Mandibular Third MolarProcedure or surgery
Also called Impacted third molar surgery, Mandibular third molar odontectomy
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.
methylprednisolone sodium succinateDrug
Also called Prednol-L
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.
Dexamethasone Sodium Phosphate InjectionDrug
Also called dekort
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Control Group | Experimental | 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. Receives: Procedure: Surgical Extraction of Impacted Mandibular Third Molar |
| Group 2: Methylprednisolone Group | Active comparator | 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. Receives: Procedure: Surgical Extraction of Impacted Mandibular Third Molar; Drug: methylprednisolone sodium succinate |
| Group 3: Dexamethasone Group | Active comparator | 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. Receives: Procedure: Surgical Extraction of Impacted Mandibular Third Molar; Drug: Dexamethasone Sodium Phosphate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Three-Dimensional Facial Edema
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.
Measured: Baseline (Preoperative) and Postoperative Day 3 and 7
Secondary outcomes (2)
Postoperative Pain Intensity via Visual Analog Scale
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".
Measured: Postoperative Days 1, 3, and 7
Rescue Analgesic Consumption
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.
Measured: Up to 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start2 Mar 2026
- Primary completion1 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Impacted Mandibular Third Molar ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irfan Üstündağ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Irfan Üstündağ, Inonu University
- Investigators
- irfan ustundag, dr.ogr.uyesi, Principal investigator, inonu universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628166
- Sponsor's protocol ID
- 2024-KAEK-08-3D
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 28666096Fernandez-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.
PubMed 39200756Ngeow 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.
PubMed 27287853
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Submucosal Dexamethasone Versus Methylprednisolone for Pain and Three-Dimensional Facial Edema After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07628166
- Acronym / sponsor ID
- 2024-KAEK-08-3D
- Conditions
- Impacted Mandibular Third Molar Extraction, Postoperative Pain Control, Postoperative Edema and Pain
- Keywords
- Mandibular Third Molar Surgery, Impacted Tooth Extraction, Submucosal Dexamethasone, Submucosal Methylprednisolone, Postoperative Pain, Three-Dimensional Facial Analysis, Facial Edema Volumetric Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Irfan ÜstündağUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Control Group | Experimental | Procedure: Surgical Extraction of Impacted Mandibular Third MolarPatients 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. |
| Group 2: Methylprednisolone Group | Active comparator | Procedure: Surgical Extraction of Impacted Mandibular Third Molar, Drug: methylprednisolone sodium succinateFollowing 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. |
| Group 3: Dexamethasone Group | Active comparator | Procedure: Surgical Extraction of Impacted Mandibular Third Molar, Drug: Dexamethasone Sodium Phosphate InjectionFollowing 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Extraction of Impacted Mandibular Third MolarAlso: Impacted third molar surgery, Mandibular third molar odontectomyAll 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. | Procedure or surgery | Group 1: Control Group, Group 2: Methylprednisolone Group, Group 3: Dexamethasone Group |
| methylprednisolone sodium succinateAlso: Prednol-LImmediately 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. | Drug | Group 2: Methylprednisolone Group |
| Dexamethasone Sodium Phosphate InjectionAlso: dekortImmediately 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. | Drug | Group 3: Dexamethasone Group |
Primary outcome
Change in Three-Dimensional Facial Edema
Time frame: 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.
2 secondary outcomes
Postoperative Pain Intensity via Visual Analog Scale
Time frame: Postoperative Days 1, 3, and 7
Rescue Analgesic Consumption
Time frame: Up to 7 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Results publication: PubMed 28666096Lim 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.
- Results publication: PubMed 39200756Fernandez-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.
- Results publication: PubMed 27287853Ngeow 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
irfan ustundag, dr.ogr.uyesi principal investigator
inonu universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Extraction of Impacted Mandibular Third Molar, methylprednisolone sodium succinate and Dexamethasone Sodium Phosphate Injection in people with Impacted Mandibular Third Molar Extraction and Postoperative Pain Control, run by Irfan Üstündağ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Three-Dimensional Facial Edema (time frame: Baseline (Preoperative) and Postoperative Day 3 and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07628166, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.