Ibuprofen, Reversible Pulpitis
Conditions
Keywords
reversible pulpitis, ibuprofen, dental pain
Brief summary
Effective intraoperative pain management is vital in paediatric dentistry, especially during vital pulp therapy (VPT) for reversible pulpitis. Although NSAIDs are widely used postoperatively, their role in controlling pain during treatment is less understood. To investigate the effect of preoperative ibuprofen on pain perception and physiological stress during VPT in children.
Detailed description
This prospective, randomized, controlled clinical trial will investigate the effect of preoperative ibuprofen administration on intraoperative pain during vital pulp therapy (VPT) in pediatric patients diagnosed with reversible pulpitis. The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University. Ethical approval has been obtained from the Institutional Clinical Research Ethics Committee of Inonu University (Approval No: 2024-KAEK-08; Date: 25.12.2024). Written informed consent will be obtained from the parents of all participants. A total of 44 children aged 7 to 13 years, in good general health, with deep carious lesions in a mandibular first permanent molar and a clinical diagnosis of reversible pulpitis will be included in the study. Participants will be randomly assigned in equal numbers (n=22 per group) to the intervention and control groups using a computer-generated randomization sequence and the sealed envelope method. Children in the intervention group will receive oral ibuprofen (10 mg/kg) 40 minutes prior to treatment. The control group will receive no preoperative medication. A single-blind study design will be employed: the clinician performing the procedures will be aware of group allocation, while the statistician responsible for data analysis will remain blinded. All participants will receive an inferior alveolar nerve block (IANB) before the procedure. Anesthesia will be verified with a cold test, and treatment will begin only after adequate anesthesia is confirmed. All procedures will be performed by the same pediatric dentist, following a standardized clinical protocol. The specific type of VPT (protective liner, direct pulp capping, partial pulpotomy, or coronal pulpotomy) will be selected based on clinical presentation. Intraoperative pain will be assessed using both physiological and subjective measures. Pulse rate will be continuously monitored with a fingertip pulse oximeter, with a focus on readings taken when the bur approaches within close proximity to the pulp. Subjective pain will be measured using a Visual Analogue Scale (VAS), shown to the patient at the most sensitive moment of the procedure. Postoperative VAS scores will be recorded on Days 1, 3, and 7.
Interventions
Ibuprofen was administered orally at a dose of 10 mg/kg body weight, 40 minutes before the start of the dental procedure. This intervention was designed to reduce intraoperative pain and pulse elevation associated with reversible pulpitis.
Sponsors
Inonu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* Children with no history of systemic disease, * Demonstrated cooperative behaviour during treatment, * Parental consent obtained for study participation, * Presence of a first permanent mandibular molar with: 1. Clinical and radiographic diagnosis of reversible pulpitis, 2. Deep carious lesion extending beyond three-quarters of dentine thickness on periapical/bitewing radiographs (ICDAS score 5-6), 3. Positive cold test response with Endo-Ice (Hygienic Corp., Akron, OH, USA) producing short-lasting pain (subsiding within \<10 seconds after stimulus removal), 4. No clinical signs of swelling, abscess, or sinus tract, 5. Absence of abnormal tooth mobility, 6. Restorability of the tooth.
Exclusion criteria
* Presence of primary teeth requiring treatment, * Clinical or radiographic diagnosis of irreversible pulpitis, necrotic pulp, apical lesion, swelling, abscess, or sinus tract, * Analgesic intake within the preceding 12 hours, * Known allergy to ibuprofen or local anaesthetics, * Neurological or psychiatric developmental disorders, * Presence of systemic illness, * Existing gastrointestinal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity From Baseline (Pre-Operative) to Immediately During the Procedure (Day 0), Measured by the Visual Analogue Scale (VAS) | Pre-Operative (Baseline) and Immediately During the Procedure (Day 0) | Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The change will be calculated as the score immediately during the procedure (Day 0) minus the Baseline (Pre-Operative) score. Higher scores indicate worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 1, Measured by the Visual Analogue Scale (VAS) | Pre-Operative (Baseline) and 1 days post-treatment (Day 1) | Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The Baseline (Pre-Operative) VAS score will be compared with the VAS score reported by the participant on Day 1. On Day 1, participants will be contacted by phone and asked to rate their pain using the same VAS tool. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS) | Pre-Operative (Baseline) and 3 days post-treatment (Day 3) | Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The Baseline (Pre-Operative) VAS score will be compared with the VAS score reported by the participant on Day 3. On Day 3, participants will be contacted by phone and asked to rate their pain using the same VAS tool. |
| Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS)Analogue Scale (VAS) | Pre-Operative (Baseline) and 7 days post-treatment (Day 7) | Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The Baseline (Pre-Operative) VAS score will be compared with the VAS score reported by the participant on Day 7. On Day 7, participants will be contacted by phone and asked to rate their pain using the same VAS tool. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
A total of 46 children were enrolled in the study. Participants were randomized into two groups (23 in the control group, 23 in the ibuprofen group). Two participants did not complete the study due to protocol violations, leaving 44 participants who completed the trial.
Pre-assignment details
Randomization was performed using a sealed envelope method; the envelope contents were prepared by a third researcher before the examination. Because double-blinding was not possible, a single-blind design was employed. The clinician performing the procedure was aware of the groups, but the statistician performing the data analysis was unaware of the groups.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Children in this group received no preoperative medication before undergoing vital pulp therapy. Standard local anesthesia was administered prior to the procedure.The mean age of participants was 9.32 years (SD ±1.96). The group consisted of 16 females (72.7%) and 6 males (27.3%). | 22 |
| Ibuprofen Group Children in this group received a single dose of ibuprofen (10 mg/kg) orally, 40 minutes prior to vital pulp therapy. The goal was to evaluate the effect of preoperative ibuprofen on intraoperative pain and physiological stress.
Ibuprofen 10 mg/kg: Ibuprofen was administered orally at a dose of 10 mg/kg body weight, 40 minutes before the start of the dental procedure. This intervention was designed to reduce intraoperative pain and pulse elevation associated with reversible pulpitis.The mean age of participants was 9.59 years (SD ±1.56). The group consisted of 14 females (63.6%) and 8 males (36.4%). | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Control Group | Ibuprofen Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 22 Participants | 44 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.32 years STANDARD_DEVIATION 1.96 | 9.59 years STANDARD_DEVIATION 1.76 | 9.45 years STANDARD_DEVIATION 1.76 |
| Race/Ethnicity, Customized Turkish | 22 Participants | 22 Participants | 44 Participants |
| Region of Enrollment Turkey | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Change in Pain Intensity From Baseline (Pre-Operative) to Immediately During the Procedure (Day 0), Measured by the Visual Analogue Scale (VAS)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The change will be calculated as the score immediately during the procedure (Day 0) minus the Baseline (Pre-Operative) score. Higher scores indicate worse pain.
Time frame: Pre-Operative (Baseline) and Immediately During the Procedure (Day 0)
Population: 7-13 years children
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Pain Intensity From Baseline (Pre-Operative) to Immediately During the Procedure (Day 0), Measured by the Visual Analogue Scale (VAS) | 5.05 score on a scale | Standard Deviation 3.51 |
| Ibuprofen Group | Change in Pain Intensity From Baseline (Pre-Operative) to Immediately During the Procedure (Day 0), Measured by the Visual Analogue Scale (VAS) | 0.64 score on a scale | Standard Deviation 1.14 |
Secondary
Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 1, Measured by the Visual Analogue Scale (VAS)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The Baseline (Pre-Operative) VAS score will be compared with the VAS score reported by the participant on Day 1. On Day 1, participants will be contacted by phone and asked to rate their pain using the same VAS tool.
Time frame: Pre-Operative (Baseline) and 1 days post-treatment (Day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 1, Measured by the Visual Analogue Scale (VAS) | 0.59 score on a scale | Standard Deviation 1.37 |
| Ibuprofen Group | Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 1, Measured by the Visual Analogue Scale (VAS) | 0.68 score on a scale | Standard Deviation 1.39 |
Other Pre-specified
Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The Baseline (Pre-Operative) VAS score will be compared with the VAS score reported by the participant on Day 3. On Day 3, participants will be contacted by phone and asked to rate their pain using the same VAS tool.
Time frame: Pre-Operative (Baseline) and 3 days post-treatment (Day 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS) | 0.14 score on a scale | Standard Deviation 0.47 |
| Ibuprofen Group | Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS) | 0.23 score on a scale | Standard Deviation 0.75 |
Other Pre-specified
Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS)Analogue Scale (VAS)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The Baseline (Pre-Operative) VAS score will be compared with the VAS score reported by the participant on Day 7. On Day 7, participants will be contacted by phone and asked to rate their pain using the same VAS tool.
Time frame: Pre-Operative (Baseline) and 7 days post-treatment (Day 7)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS)Analogue Scale (VAS) | 0.05 score on a scale | Standard Deviation 0.21 |
| Ibuprofen Group | Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS)Analogue Scale (VAS) | 0.09 score on a scale | Standard Deviation 0.29 |