Symptomatic irreversible pulpitis Oral Health Symptomatic irreversible pulpitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 60 years 2. Male or female 2. Acute dental pain in posterior maxillary or mandibular molar teeth 4. Diagnosed with symptomatic irreversible pulpitis with or without symptomatic apical periodontitis
Exclusion criteria
Exclusion criteria: 1. History of American Society of Anesthesiologists (1963) III-VI status 2. Pregnancy or nursing 3. Mental disability 4. History of allergy to nonsteroidal anti-inflammatory drugs, and analgesic treatment during the 12 hours prior to presentation 5. If the subject tooth has moderate or severe marginal periodontitis, horizontal or vertical fractures, internal or external root resorption, root canal calcification, or a nonrestorable crown defect 6. If an opposing and/or neighbouring tooth has defective restorations, deep caries, moderate or severe marginal periodontitis, wear, or history of recent tooth preparation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain intensity is measured using a visual analogue scale (VAS) at baseline, after the anaesthetic effect has disappeared (Day 0) and 1, 3, and 7 days post-treatment 2. Pain relief is assessed by reviewing “Clinical Evaluation Questionnaire” forms and calculating the changes in pain intensity between each reporting time points (baseline-Day 0; baseline- Day 1; baseline-Day 3; baseline-Day 7; Day 0-Day 1; Day 0-Day 3; Day 0-Day 7; Day 1-Day 3; Day 1-Day 7; Day 3-Day 7) 3. Total time per procedure per tooth is expressed in minutes during surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Daily analgesic requirements from the time the anaesthetic wore off (Day 0) throughout the 7 days post-surgery is measured by reviewing “Clinical Evaluation Questionnaire” forms and calculating the frequencies and amounts of analgesic use per patient at Day 0, and 1, 2, 3, 4, 5, 6, and 7 days post-treatment 2. Proportion of patients with thermal sensitivity is measured by reviewing “Clinical Evaluation Questionnaire” forms and calculating the percentage at baseline, after the anaesthetic effect has disappeared (Day 0) and 1, 3, and 7 days post-treatment 3. Thermal sensitivity relief is assessed by reviewing “Clinical Evaluation Questionnaire” forms and calculating the changes in prevalence of thermal sensitivity between each reporting time points (baseline-Day 0; baseline- Day 1; baseline-Day 3; baseline-Day 7; Day 0-Day 1; Day 0-Day 3; Day 0-Day 7; Day 1-Day 3; Day 1-Day 7; Day 3-Day 7) 4. Proportion of patients with chewing sensitivity is measured by reviewing “Clinical Evaluation Questionnaire” forms and calculating the percentage at baseline, after the anaesthetic effect has disappeared (Day 0) and 1, 3, and 7 days post-treatment 5. Chewing sensitivity relief is assessed by reviewing “Clinical Evaluation Questionnaire” forms and calculating the changes in prevalence of chewing sensitivity between each reporting time points (baseline-Day 0; baseline- Day 1; baseline-Day 3; baseline-Day 7; Day 0-Day 1; Day 0-Day 3; Day 0-Day 7; Day 1-Day 3; Day 1-Day 7; Day 3-Day 7) | — |
Countries
Turkey