Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Protocol No. P-604/28.02.2020 | Other Identifier | Ethics Committee MU-Plovdiv |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Radka Ivanova Masaldzhieva, Dept. of Health Care Management, Faculty of Public Health, MU-Plovdiv | UNKNOWN |
| Mariya Vlado Ivanovska, Dept. of Microbiology and Immunology, Faculty of Medicine, MU-Plovdiv | UNKNOWN |
| Ralitsa Dimitrova Raycheva, Dept. of Social Medicine and Public Health, Faculty of Public Health, MU-Plovdiv |
Not provided
Not provided
Not provided
Not provided
A prospective cohort of 40 consecutive patients with bilateral impacted mandibular third molars underwent two sequential surgical extractions separated by a two-week interval. Serum kynurenic acid (KYNA) and serotonin were measured preoperatively and 24 hours after each procedure. The study examined longitudinal dynamics of kynurenine pathway biomarkers, their variation across Pederson surgical difficulty grades, and their relationship with postoperative pain and state anxiety.
Participants were randomised to placebo, ibuprofen 400 mg, or ibuprofen 400 mg plus gabapentin 300 mg administered preemptively 1 hour before incision and continued at 8-hourly intervals for 24 hours. Blood samples were collected at four timepoints (T0 Op1, T24 Op1, T0 Op2, T24 Op2) and analysed by ELISA for serum KYNA and serotonin. Postoperative pain was assessed by VAS at 2, 6, 12, 24, 48, and 72 hours. State-trait anxiety was assessed using the STAI Form Y before each operation. Pederson difficulty index was applied independently by two calibrated examiners. The biomarker analysis is reported observationally with pharmacological allocation treated as a covariate. Clinical data and samples were collected at the Department of Oral Surgery, Faculty of Dental Medicine, Medical University of Plovdiv, Bulgaria, during 2017-2018; laboratory biomarker analyses were conducted under Project No. DPDT-12/2019, Medical University of Plovdiv, and completed in 2020.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Identical-appearing capsules administered 1 hour before incision, repeated every 8 hours for 24 hours. N=10. |
|
| Ibuprofen | Active Comparator | Ibuprofen 400 mg oral capsules administered 1 hour before incision, repeated every 8 hours for 24 hours. N=15 |
|
| Ibuprofen + Gabapentin | Experimental | Ibuprofen 400 mg plus Gabapentin 300 mg oral capsules administered 1 hour before incision, repeated every 8 hours for 24 hours. N=15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Identical-appearing oral capsules administered preemptively 1 hour before incision and every 8 hours for 24 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum kynurenic acid (KYNA) concentration | Change in serum KYNA from preoperative baseline (T0) to 24 hours postoperative (T24) at each of two sequential operations, assessed by ELISA | Preoperative baseline and 24 hours postoperative at each operation |
| Serum serotonin concentration | Change in serum serotonin from preoperative baseline (T0) to 24 hours postoperative (T24) at each of two sequential operations, assessed by ELISA | Preoperative baseline and 24 hours postoperative at each operation |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity | Pain assessed using a 100 mm Visual Analogue Scale (VAS; 0 = no pain, 100 = worst imaginable pain) | 2, 6, 12, 24, 48, and 72 hours postoperative at each operation |
| State anxiety |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deyan Neychev, MD, PhD | Medical University of Plovdiv | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dental Medicine | Plovdiv | Plovdiv | 4002 | Bulgaria |
Individual participant data are not planned for public sharing. Anonymized data are available from the corresponding author on reasonable request.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000090862 | Neuroinflammatory Diseases |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
| UNKNOWN |
Each participant underwent two sequential surgical procedures (bilateral impacted mandibular third molar extractions) separated by a two-week interval, serving as their own control across both operative exposures.
Not provided
Not provided
Double-blind achieved using identical-appearing capsules. Biochemical analyses performed blinded to surgical timepoint and pharmacological group allocation.
| Ibuprofen | Drug | Ibuprofen 400 mg oral capsules administered preemptively 1 hour before incision and every 8 hours for 24 hours. |
|
| Ibuprofen + Gabapentin | Drug | Ibuprofen 400 mg plus Gabapentin 300 mg oral capsules administered preemptively 1 hour before incision and every 8 hours for 24 hours. |
|
Preoperative state anxiety assessed using the State-Trait Anxiety Inventory (STAI Form Y), State subscale
| Preoperative baseline at each operation |
| KYNA variation across Pederson surgical difficulty grades | Serum KYNA at 24 hours postoperative compared across Pederson difficulty grades (5-9), assessed by Kruskal-Wallis test | 24 hours postoperative at Operation 1 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D007249 | Inflammation |
| D001523 | Mental Disorders |
| D000588 |
| Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D003509 | Cyclohexanecarboxylic Acids |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |