Pain Management in Teeth With Reversible Pulpitis: A Randomised Controlled Trial
Phase: EARLY_PHASE1
Conditions: Reversible Pulpitis, Ibuprofen
Sponsor: Inonu University

Official Title:
Pain Management in Teeth with Reversible Pulpitis: A Randomised Controlled Trial
NCT Number:
Pending
Document Date:
August 2, 2025

RESULTS
Note: This study protocol outlines a planned clinical trial. As of the document date (August 2, 2025)

STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN
Study  Title:  The  Effect  of  Preoperative  Ibuprofen  Administration  on  Pain  During  Vital  Pulp
Therapy in Children Diagnosed with Reversible Pulpitis: A Randomized Controlled Trial
Document Type: Study Protocol and Statistical Analysis Plan
Investigator: Dr. Merve Bilmez Selen
Institution: Inönü University Faculty of Dentistry
Date: July 25, 2025
NCT Number: Pending
Note: This document is submitted for public posting in ClinicalTrials.gov.
STUDY PROTOCOL
1. Introduction
Pain experienced during dental procedures is a major factor negatively affecting cooperation in
pediatric  patients.  In  cases  of  reversible  pulpitis,  preoperative  use  of  analgesics  during  vital
pulp therapy (VPT) may contribute significantly to pain management.
2. Objective
The  aim  of  this  study  is  to  evaluate  the  effect  of  preoperative  ibuprofen  administration  on
intraoperative  pain  and  physiological  stress  in  children  undergoing  VPT  on  mandibular  first
permanent molars diagnosed with reversible pulpitis.
3. Hypothesis
Preoperative administration of ibuprofen will significantly reduce intraoperative pain levels.
4. Methods
- Design: Prospective, randomized, controlled clinical trial
- Setting: Department of Pediatric Dentistry, Faculty of Dentistry, Inönü University
- Participants:
• Age: 7–13 years
• Condition: Reversible pulpitis in mandibular first permanent molars
• Sample size: 44 patients (22 intervention, 22 control)
- Randomization: Computer-generated random sequence using sealed-envelope method
- Blinding: Single-blind (statistician blinded)
- Intervention:

• Intervention group: Oral ibuprofen (10 mg/kg) 40 minutes before treatment
• Control group: No preoperative medication
- Anesthesia: Inferior alveolar nerve block (articaine HCl 4% with epinephrine 1:100,000)
5. Procedure and Follow-up
VPT  will  be  performed  (direct  pulp  capping,  partial  or  total  pulpotomy  as  appropriate).
Intraoperative pain will be assessed using the Visual Analogue Scale (VAS). Pulse rate will be
monitored using a fingertip pulse oximeter. Postoperative pain will be assessed using VAS on
Days 1, 3, and 7.
6. Ethical Approval
Ethical approval for this study was obtained from the Inönü University Clinical Research Ethics
Committee (Approval No: 2024-KAEK-08; Date: December 25, 2024). Written informed consent
will  be  obtained  from  the  legal  guardians  of  all  participants.  The  study  will  be  conducted  in
accordance with the Declaration of Helsinki.
7. Timeline
• Enrollment: July 2025
• Data collection: July–August 2025
• Primary completion date: Estimated August 2025
STATISTICAL ANALYSIS PLAN
1. Objective
This  statistical  analysis  plan  aims  to  outline  the  methodology  for  analyzing  the  effect  of
preoperative  ibuprofen  administration  on  intraoperative  pain  (measured  using  the  Visual
Analogue Scale – VAS) and physiological stress (measured via pulse rate variation) in children
undergoing vital pulp therapy (VPT) for reversible pulpitis.
2. Sample Size Calculation
The  required  sample  size  was  determined  using  G*Power  software  (version  3.1)  with  the
following parameters:
- Effect size (Cohen’s d): 0.8
- Power: 80%
- Alpha (Type I error): 0.05
- Minimum required participants: 22 per group
3. Descriptive Statistics

-  Continuous  variables  (e.g.,  age,  VAS  scores,  pulse  rates)  will  be  expressed  as  mean  ±
standard deviation (SD)
- Categorical variables (e.g., sex) will be presented as frequency and percentage
4. Normality Testing
The Shapiro–Wilk test will be used to assess the normality of continuous data distributions.
5. Comparative Analyses
- Between-group comparisons:
• For normally distributed data: Independent samples t-test
• For non-normally distributed data: Mann–Whitney U test
- Within-group comparisons (e.g., pulse change): Wilcoxon signed-rank test
- Longitudinal analysis of postoperative pain (Days 1, 3, and 7): Friedman test
- Subgroup analyses:
• Sex-based and apex closure status comparisons using Mann–Whitney U test
- Correlation analyses:
• Spearman’s rank correlation coefficient to assess the relationship between pulse change and
VAS scores, and between age and pain scores
6. Statistical Significance
A p-value < 0.05 will be considered statistically significant.
7. Software
All analyses will be conducted using IBM SPSS Statistics for Windows, version 27.0 (IBM Corp.,
Armonk, NY, USA).