Comparative Assessment of Three-Dimensional Soft and Hard Tissue Changes Following Rapid Maxillary Expansion With Face Mask, Mini Maxillary Protractor, and Modified Splints, Elastics, and Chin Cup Protocols in Patients With Class III Malocclusion: A Prospective Randomized Controlled Clinical Trial
Phase: NA
Conditions: Class III Skeletal Malocclusion
Sponsor: TC Erciyes University

Study Protocol & 
Statistical Analysis Plan (SAP) 
Official Title: 
Comparative Assessment of Three-Dimensional Soft and Hard Tissue Changes Following 
Rapid Maxillary Expansion with Face Mask, Mini Maxillary Protractor, and Modified Splints, 
Elastics, and Chin Cup Protocols in Patients with Class III Malocclusion: A Prospective 
Randomized Controlled Clinical Trial 
 
NCT Number: 
(To be assigned after registration) 
 
Document Date: 
[21.02.2024] 
 
Funding: 
This study was supported by the Scientific Research Projects Coordination of Erciyes University 
(BAP, project number: ID-TDH 2024-13977) 
 
Principal Investigator: 
Assoc. Prof. Dr. Gökhan Çoban 
Department of Orthodontics, Faculty of Dentistry 
Erciyes University, Kayseri, Turkey 
 
Sub-Investigator: 
Research Assistant Dr. Tuba Ünlü Çiftçi 
Department of Orthodontics, Faculty of Dentistry 
Erciyes University, Kayseri, Turkey 
 
 
 

Study Protocol 
Study Type and Design 
Interventional, Randomized Controlled Clinical Trial 
Allocation: Randomized 
Intervention Model: Parallel Assignment 
Masking: None (Open Label) 
Primary Purpose: Treatment 
Study Population 
Growing patients with Class III skeletal malocclusion, aged 9–12 years. 
Interventions 
1. Rapid Maxillary Expansion with Face Mask (RME/FM) 
2. Mini Maxillary Protractor (MMP) 
3. Modified Splint with Elastics and Chin Cup (Modified SEC III) 
4. Control Group (archival untreated Class III patients) 
Primary Outcome Measures 
Change in 3D soft tissue profile (facial convexity, mentolabial angle) from baseline to 9 
months. Positional changes of anthropometric soft tissue landmarks. 
Secondary Outcome Measures 
Change in skeletal parameters (SNA, SNB, ANB, overjet, overbite) from baseline to 9 
months.Dentoalveolar changes (incisor inclination, linear distances). 
 
Study Dates 
Start Date: February 21 2024 
Primary Completion Date: January 09 2025 
Study Completion Date: March 03 2025 
Ethics 
Approved by the Clinical Research Ethics Committee of Erciyes University (Approval No: 
2024/44, Date: Jan 10, 2024). Approval also obtained from the Turkish Medicines and 
Medical Devices Agency (E-61749811-000-2961523, No: 2023-213). 
Statistical Analysis Plan (SAP) 
Official Title: 
Comparative Assessment of Three-Dimensional Soft and Hard Tissue Changes Following 
Rapid Maxillary Expansion with Face Mask, Mini Maxillary Protractor, and Modified Splints, 
Elastics, and Chin Cup Protocols in Patients with Class III Malocclusion: A Prospective 

Randomized Controlled Clinical Trial 
 
NCT Number: 
(To be assigned after registration) 
 
Document Date: 
[09.01.2025] 
 
Funding: 
This study was supported by the Scientific Research Projects Coordination of Erciyes University 
(BAP, project number: ID-TDH 2024-13977) 
 
Principal Investigator: 
Assoc. Prof. Dr. Gökhan Çoban 
Department of Orthodontics, Faculty of Dentistry 
Erciyes University, Kayseri, Turkey 
 
Sub-Investigator: 
Research Assistant Dr. Tuba Ünlü Çiftçi 
Department of Orthodontics, Faculty of Dentistry 
Erciyes University, Kayseri, Turkey 
 
 
 

Statistical Analysis Plan (SAP) 
Software 
SPSS Statistics version 21.0 (IBM Corp., Armonk, NY, USA). 
Normality Testing 
Shapiro–Wilk test used to evaluate distribution of continuous variables. 
Between-Group Comparisons 
Parametric variables: One-way ANOVA with post-hoc Tukey’s tests. 
Non-parametric variables: Kruskal–Wallis test with post-hoc Dunn’s or Durbin–Conover 
tests. 
Within-Group Comparisons (T0 vs T1) 
Parametric: Paired samples t-test. 
Non-parametric: Wilcoxon signed-rank test. 
Sex-Based Comparisons 
Independent samples t-test for parametric variables. 
Mann–Whitney U test for non-parametric variables. 
Reliability Testing 
Intra-examiner reproducibility assessed by repeating 10 randomly selected cases at 1-
month interval. 
Reliability calculated using Intraclass Correlation Coefficient (ICC) and Cronbach’s alpha. 
Level of Significance 
A p-value of <0.05 considered statistically significant.