Trial Outcomes & Findings for Pain Management in Teeth With Reversible Pulpitis (NCT NCT07114198)
NCT ID: NCT07114198
Last Updated: 2025-09-24
Results Overview
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.
COMPLETED
EARLY_PHASE1
46 participants
Pre-Operative (Baseline) and Immediately During the Procedure (Day 0)
2025-09-24
Participant Flow
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.
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.
Participant milestones
| Measure |
Control Group
Children in this group received no preoperative medication before undergoing vital pulp therapy. Standard local anesthesia was administered prior to the procedure.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Control Group
Children in this group received no preoperative medication before undergoing vital pulp therapy. Standard local anesthesia was administered prior to the procedure.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
TURKEY
Baseline characteristics by cohort
| Measure |
Control Group
n=22 Participants
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%).
|
Ibuprofen Group
n=22 Participants
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%).
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.32 years
STANDARD_DEVIATION 1.96 • n=5 Participants
|
9.59 years
STANDARD_DEVIATION 1.76 • n=7 Participants
|
9.45 years
STANDARD_DEVIATION 1.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Turkish
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
22 participants
n=5 Participants • TURKEY
|
22 participants
n=7 Participants • TURKEY
|
44 participants
n=5 Participants • TURKEY
|
PRIMARY outcome
Timeframe: Pre-Operative (Baseline) and Immediately During the Procedure (Day 0)Population: 7-13 years children
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.
Outcome measures
| Measure |
Control Group
n=22 Participants
Children in this group received no preoperative medication before undergoing vital pulp therapy. Standard local anesthesia was administered prior to the procedure.
|
Ibuprofen Group
n=22 Participants
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.
|
|---|---|---|
|
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
|
0.64 score on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=22 Participants
Children in this group received no preoperative medication before undergoing vital pulp therapy. Standard local anesthesia was administered prior to the procedure.
|
Ibuprofen Group
n=22 Participants
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.
|
|---|---|---|
|
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
|
0.68 score on a scale
Standard Deviation 1.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=22 Participants
Children in this group received no preoperative medication before undergoing vital pulp therapy. Standard local anesthesia was administered prior to the procedure.
|
Ibuprofen Group
n=22 Participants
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.
|
|---|---|---|
|
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
|
0.23 score on a scale
Standard Deviation 0.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=22 Participants
Children in this group received no preoperative medication before undergoing vital pulp therapy. Standard local anesthesia was administered prior to the procedure.
|
Ibuprofen Group
n=22 Participants
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.
|
|---|---|---|
|
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
|
0.09 score on a scale
Standard Deviation 0.29
|
Adverse Events
Control Group
Ibuprofen Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place