Effect of Preemptive Etoricoxib and Dexamethasone on Wound Healing and Clinical Parameters After Third Molar Surgery

NCT05791721 | Completed Phase 4 DMC

• 1 other identifier: 36/22
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare preemptive single-dose selective cyclooxygenase 2 (COX-2) inhibitor - etoricoxib and dexamethasone use in systemically healthy patients during the surgical extraction of impacted mandibular third molars. The main questions it aims to answer/evaluate are:

• the level of inflammatory and early wound healing mediators in patients' saliva during early postoperative phase
• clinical postoperative parameters such as pain, swelling and trismus
• patient satisfaction with the treatment
• rescue medication consumed during the postoperative period
• incidence of adverse events Participants indicated for mandibular third molar surgery will be asked to:
• take premedication (etoricoxib or dexamethasone) before surgical extraction
• provide saliva samples before and following the surgery at regular check-ups
• note the amount of rescue medication taken and pain intensity in different time points
• perform clinical measurements of swelling and trismus at regular check-up visits
• answer the questions about satisfaction and potential adverse events, if occur Researchers will compare preemptive single-dose etoricoxib, preemptive single-dose dexamethasone, and no premedication in impacted mandibular third molar surgery, to see if there are differences in inflammatory response and early wound healing, as well as in clinical postoperative parameters, patient satisfaction with the treatment and incidence of potential adverse events.

Conditions

Surgical Wound; Post Operative Pain

Keywords

Third Molar; Analgesia; Saliva

Outcome Measures

Primary Outcomes (8)

• Relative gene expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use

  To measure the relative gene expression of COX-2, PGE2, ALP, RUNX2, OCN in saliva samples obtained 1 hour before surgical removal of impacted mandibular third molar

  1 hour before surgery

• Protein expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use

  To measure the protein expression of PGE2 and MAR1 in saliva samples obtained 1 hour before surgical removal of impacted mandibular third molar

  1 hour before surgery

• Relative gene expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use

  To measure the relative gene expression of COX-2, PGE2, ALP, RUNX2, OCN in saliva samples obtained immediately after surgical removal of impacted mandibular third molar

  immediately after surgery

• Protein expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use

  To measure the protein expression of PGE2 and MAR1 in saliva samples obtained immediately after surgical removal of impacted mandibular third molar

  immediately after surgery

• Relative gene expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use

  To measure the relative gene expression of COX-2, PGE2, ALP, RUNX2, OCN in saliva samples obtained 48 hours after surgical removal of impacted mandibular third molar

  48 hours after surgery

• Protein expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use

  To measure the protein expression of PGE2 and MAR1 in saliva samples obtained 48 hours after surgical removal of impacted mandibular third molar

  48 hours after surgery

• Relative gene expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use

  To measure the relative gene expression of COX-2, PGE2, ALP, RUNX2, OCN in saliva samples obtained on Day 7 after surgical removal of impacted mandibular third molar

  Day 7 after surgery

• Protein expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use

  To measure the protein expression of PGE2 and MAR1 in saliva samples obtained on Day 7 after surgical removal of impacted mandibular third molar

  Day 7 after surgery

Secondary Outcomes (41)

• Evaluation of preoperative pain on visual analog scale

  1 hour before surgery

• Evaluation of postoperative pain on visual analog scale

  Hour 2 after surgery

• Evaluation of postoperative pain on visual analog scale

  Hour 4 after surgery

• Evaluation of postoperative pain on visual analog scale

  Hour 6 after surgery

• Evaluation of postoperative pain on visual analog scale

  Hour 8 after surgery

Study Arms (3)

Etoricoxib group

ACTIVE COMPARATOR

One hour preoperatively, preemptive, single-dose etoricoxib tablet in dosage of 90 mg will be administered orally

Drug: Etoricoxib 90 Mg Oral Tablet

Dexamethasone group

ACTIVE COMPARATOR

One hour preoperatively, preemptive, single-dose dexamethasone in dosage of 4 mg will be administered intramuscularly

Drug: Dexamethasone 4mg

Control group

NO INTERVENTION

In this group, one hour preoperatively no medication will be administered

Interventions

Etoricoxib 90 Mg Oral Tablet DRUG

Intervention will be applied one hour before surgical extraction of impacted mandibular third molar

Also known as: There is no other intervention name

Etoricoxib group

Dexamethasone 4mg DRUG

Intervention will be applied one hour before surgical extraction of impacted mandibular third molar

Also known as: There is no other intervention name

Dexamethasone group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy individuals (ASA I by American Society of Anesthesiologists classification);
• Age 18-30 years;
• Absence of hypersensitivity to any of the medications in the study;
• Subjects capable to understand the protocol and sign an informed consent form.

You may not qualify if:

• Systemic disorders;
• Individuals in gestation or lactation period;
• Radiographic presence of potential cystic or tumorous lesions in the region of the extraction-required IMTM;
• Any symptoms or clinical signs of the infection caused by the extraction-required IMTM up to 10 days preoperatively;
• Use of NSAIDs or corticosteroids within 10 days before the surgery.

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

School of Dental medicine, University of Belgrade

Belgrade, 11000, Serbia

Location

Related Publications (2)

• Martins-de-Barros AV, Barros AM, Siqueira AK, Lucena EE, Sette de Souza PH, Araujo FA. Is Dexamethasone superior to Ketorolac in reducing pain, swelling and trismus following mandibular third molar removal? A split mouth triple-blind randomized clinical trial. Med Oral Patol Oral Cir Bucal. 2021 Mar 1;26(2):e141-e150. doi: 10.4317/medoral.24088.

  PMID: 33247572 BACKGROUND

• Mijailovic I, Janjic B, Milicic B, Todorovic A, Ilic B, Misic T, Markovic N, Markovic A. Comparison of preemptive etoricoxib and dexamethasone in third molar surgery - a randomized controlled clinical trial of patient-reported and clinical outcomes. Clin Oral Investig. 2023 Sep;27(9):5263-5273. doi: 10.1007/s00784-023-05146-4. Epub 2023 Jul 14.

  PMID: 37452140 DERIVED

Related Links

• The study was conducted with ASA I individuals who were submitted to preemptive 8mg dexamethasone or 20mg ketorolac tromethamine 1h before surgical third molar extraction

MeSH Terms

Conditions

Surgical Wound; Pain, Postoperative; Agnosia

Interventions

Etoricoxib; Tablets; Dexamethasone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Aleksa B Markovic

  School of Dental Medicine, University of Belgrade

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: March 30, 2023
• Study Start: October 11, 2021
• Primary Completion: December 26, 2022
• Study Completion: December 26, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)