Post Operative Pain Clinical Trial
Official title:
Preemptive Use of Etoricoxib and Dexamethasone: Effect on Early Bone Healing, Inflammatory Response, and Postoperative Parameters After Impacted Lower Third Molar Surgery
Verified date | March 2023 |
Source | University of Belgrade |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | December 26, 2022 |
Est. primary completion date | December 26, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Serbia | School of Dental medicine, University of Belgrade | Belgrade |
Lead Sponsor | Collaborator |
---|---|
University of Belgrade |
Serbia,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Evaluation of preoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | 1 hour before surgery | |
Secondary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | Hour 2 after surgery | |
Secondary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | Hour 4 after surgery | |
Secondary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | Hour 6 after surgery | |
Secondary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | Hour 8 after surgery | |
Secondary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | Hour 10 after surgery | |
Secondary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | Hour 12 after surgery | |
Secondary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | Hour 24 after surgery | |
Secondary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | Hour 48 after surgery | |
Secondary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | Hour 72 after surgery | |
Secondary | Evaluation of postoperative pain on visual analog scale | Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | Day 7 after surgery | |
Secondary | Evaluation of preoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | 1 hour before surgery | |
Secondary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | Hour 2 after surgery | |
Secondary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | Hour 4 after surgery | |
Secondary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | Hour 6 after surgery | |
Secondary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | Hour 8 after surgery | |
Secondary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | Hour 10 after surgery | |
Secondary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | Hour 12 after surgery | |
Secondary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | Hour 24 after surgery | |
Secondary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | Hour 48 after surgery | |
Secondary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | Hour 72 after surgery | |
Secondary | Evaluation of postoperative pain on verbal rating scale | Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | Day 7 after surgery | |
Secondary | Evaluation of preoperative lobule-pogonion distance | Baseline lobule-pogonion distance will be measured on the side requiring operation by means of a soft tape, and expressed in millimeters (mm). | 1 hour before surgery | |
Secondary | Evaluation of postoperative swelling | Postoperative swelling will be assessed through measurement of lobule-pogonion distance on the operated side by means of a soft tape, and expressed in millimeters (mm). | Hour 24 after surgery | |
Secondary | Evaluation of postoperative swelling | Postoperative swelling will be assessed through measurement of lobule-pogonion distance on the operated side by means of a soft tape, and expressed in millimeters (mm). | Hour 48 after surgery | |
Secondary | Evaluation of postoperative swelling | Postoperative swelling will be assessed through measurement of lobule-pogonion distance on the operated side by means of a soft tape, and expressed in millimeters (mm). | Day 7 after surgery | |
Secondary | Evaluation of preoperative maximal inter-incisor distance | Maximal inter-incisor distance at baseline will be measured by means of a soft tape, and expressed in millimeters (mm). | 1 hour before surgery | |
Secondary | Evaluation of postoperative trismus | Trismus will be measured through assessment of a maximal inter-incisor distance by means of a soft tape, expressed in millimeters (mm). | Hour 24 after surgery | |
Secondary | Evaluation of postoperative trismus | Trismus will be measured through assessment of a maximal inter-incisor distance by means of a soft tape, expressed in millimeters (mm). | Hour 48 after surgery | |
Secondary | Evaluation of postoperative trismus | Trismus will be measured through assessment of a maximal inter-incisor distance by means of a soft tape, expressed in millimeters (mm). | Day 7 after surgery | |
Secondary | Patient satisfaction with the treatment | Patient will mark their satisfaction with the treatment using 5-point Likert scale. The question that will be asked to the patients will be as follows: "How satisfied are you at this moment with the impacted mandibular third molar surgery?". Possible answers on the 5-point Likert scale would be: "5-very satisfied", "4-satisfied", "3-neutral", "2-dissatisfied", and "1-very dissatisfied". Higher scores mean better outcome. | Hour 24 after surgery | |
Secondary | Patient satisfaction with the treatment | Patient will mark their satisfaction with the treatment using 5-point Likert scale. The question that will be asked to the patients will be as follows: "How satisfied are you at this moment with the impacted mandibular third molar surgery?". Possible answers on the 5-point Likert scale would be: "5-very satisfied", "4-satisfied", "3-neutral", "2-dissatisfied", and "1-very dissatisfied". Higher scores mean better outcome. | Hour 48 after surgery | |
Secondary | Patient satisfaction with the treatment | Patient will mark their satisfaction with the treatment using 5-point Likert scale. The question that will be asked to the patients will be as follows: "How satisfied are you at this moment with the impacted mandibular third molar surgery?". Possible answers on the 5-point Likert scale would be: "5-very satisfied", "4-satisfied", "3-neutral", "2-dissatisfied", and "1-very dissatisfied". Higher scores mean better outcome. | Day 7 after surgery | |
Secondary | Rescue medication intake | Patients will be instructed to note each rescue medication intake. | At any time during 7 days of follow up | |
Secondary | Day of rescue medication intake | Patients will be instructed to note the day when each rescue medication has been taken. Options provided to the patients would be: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7. | At any time during 7 days of follow up | |
Secondary | Time of rescue medication intake in hours | Patients will be instructed to note the time in hours (h) when each rescue medication has been taken. | At any time during 7 days of follow up | |
Secondary | Time of rescue medication intake in minutes | Patients will be instructed to note the time in minutes (min) when each rescue medication has been taken. | At any time during 7 days of follow up | |
Secondary | Pain intensity on visual analog scale during each rescue medication intake | Patients will be instructed to note pain intensity during each rescue medication intake on visual analog scale where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. | At any time during 7 days of follow up | |
Secondary | Pain intensity on verbal rating scale during each rescue medication intake | Patients will be instructed to note pain intensity during each rescue medication intake on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). | At any time during 7 days of follow up | |
Secondary | Dosage of each rescue medication intake | Patients will be instructed to note the dosage of each rescue medication used. | At any time during 7 days of follow up | |
Secondary | Incidence of adverse events | Patients will be instructed to write any postoperative adverse event if occurs | At any time during 7 days of follow up |
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