Evaluation of Crown Fractures in Permanent Teeth Following Dental Trauma Using the Modified Baysal Dental Trauma Index and Clinical Follow-Up of Their Treatments
Phase: NA
Conditions: Dental Trauma, Crown Fractures, Tooth Fractures
Sponsor: Inonu University

Study Protocol and Statistical Analysis Plan 
Cover Page 
 
Study Title: Evaluation and Treatment of Crown Fractures in Permanent Teeth Following 
Dental Trauma Using the Modified Baysal Dental Trauma Index and Clinical Follow-Up of 
Their Treatments 
Brief Title: Evaluation and Treatment of Crown Fractures Using the Modified Baysal Dental 
Trauma Index 
NCT Number: [Not yet assigned] 
Unique Protocol ID: 2023/69 
Date: [29.07.2025] 
 
1. Protocol Summary 
 
This prospective observational study aims to evaluate the clinical and radiographic 
outcomes of treatments applied to permanent teeth with complicated and uncomplicated 
crown fractures following traumatic dental injuries, using the Modified Baysal Dental 
Trauma Index (MB-DTI) for assessment and follow-up. 
 
2. Objectives 
Primary Objective: To evaluate treatment success based on clinical and radiographic criteria 
at 12 months post-treatment using the Periapical Index (PAI). 
 
Secondary Objectives: 
- To assess changes in PAI scores from baseline to 12 months. 
- To compare the effectiveness of different treatment modalities (composite resin 
restoration, vital pulp therapy, regeneration, root canal treatment). 
 
3. Study Design 
 
Type: Observational, prospective cohort study 
Time Perspective: Prospective 
Follow-Up Duration: 12 months per participant 
Number of Participants: 39 
 
 

4. Study Population 
 
Inclusion Criteria: 
1. Age between 6 and 14 years 
2. Presence of traumatic dental injury involving a permanent tooth 
3. Type of injury classified as a complicated or uncomplicated crown fracture 
4. Informed consent obtained from the patient’s parent or legal guardian 
 
Exclusion Criteria: 
1. Patients younger than 6 or older than 14 years, or those presenting for non-trauma-
related dental issues 
2. Patients with traumatic dental injuries other than crown fractures (e.g., luxation, 
avulsion) 
 
5. Sample Size Determination 
 
The sample size was calculated based on statistical power analysis with effect size w = 0.5, α 
= 0.05, and power 1 – β = 0.8. For df = 2, the required total sample size was determined to 
be 39 participants. 
 
6. Interventions / Treatments 
 
Participants will receive one of the following treatments according to clinical indications: 
1. Composite resin restoration 
2. Vital pulp therapy 
3. Regeneration procedures 
4. Root canal treatment 
 
7. Outcome Measures 
 
Primary Outcome Measure: 
Title: Proportion of Treated Teeth Without Clinical Symptoms or Radiographic Pathology at 
12 Months (PAI Score ≤ 2) 
Description: Treatment success will be defined as the absence of spontaneous pain, 
swelling, sinus tract, abnormal mobility, discoloration, and the presence of radiographic 
healing or absence of periapical pathology, as assessed using the Periapical Index (PAI) by 
Ørstavik et al. (1986). Evaluations will be performed at 12 months post-treatment. 
 
Secondary Outcome Measure: 
Title: Change in Periapical Index (PAI) Score From Baseline to 12 Months 

Description: Radiographic healing will be evaluated using the PAI scoring system, 
comparing baseline and 12-month follow-up periapical radiographs. 
 
8. Statistical Analysis Plan 
 
Data will be analyzed using SPSS software. 
Descriptive statistics (mean, standard deviation, frequency) will be calculated for all 
variables. 
Comparisons between treatment groups will be performed using Chi-square test for 
categorical variables and independent t-test or Mann–Whitney U test for continuous 
variables, depending on data distribution. 
Significance level will be set at p < 0.05. 
Changes in PAI scores over time will be analyzed using the Wilcoxon signed-rank test or 
paired t-test as appropriate. 
 
9. Ethical Considerations 
 
Approval was obtained from Interventional Clinical Research Ethics Committee, Approval 
Number: 2023/69 
Written informed consent will be obtained from the parents or legal guardians of all 
participants. 
The study will comply with the Declaration of Helsinki principles.