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CTRI Number  CTRI/2025/01/079789 [Registered on: 30/01/2025] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparing Root Changes in Upper Front Teeth During Braces Treatment With and Without Removal of Side Teeth A Study Over Time 
Scientific Title of Study   A comparative radiographic evaluation of external apical root resorption of maxillary incisors in Angles Class I malocclusion patients undergoing fixed orthodontic treatment with and without first premolar extraction a Prospective Cohort Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepthy A Bhaskar 
Designation  Post Graduate Student 
Affiliation  MES DENTAL COLLEGE and HOSPITAL 
Address  MES Dental College and Hospital Department Of Orthodontics Room no 7 Palachode PO Kolathur via Perinthalmanna Malappuram Kerala

Malappuram
KERALA
679338
India 
Phone  8891656399  
Fax    
Email  dr.deepthybhaskar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vincy Antony  
Designation  Professor and HOD 
Affiliation  MES DENTAL COLLEGE and HOSPITAL 
Address  MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 Palachode PO Kolathur via Perinthalmanna Malappuram Kerala

Malappuram
KERALA
679338
India 
Phone  9846353153  
Fax    
Email  vincyantony2008@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vincy Antony  
Designation  Professor and HOD 
Affiliation  MES DENTAL COLLEGE and HOSPITAL 
Address  MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 Palachode PO Kolathur via Perinthalmanna Malappuram Kerala

Malappuram
KERALA
679338
India 
Phone  9846353153  
Fax    
Email  vincyantony2008@yahoo.com  
 
Source of Monetary or Material Support  
MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 Palachode PO Kolathur via Perinthalmanna Malappuram Kerala India Pin- 679 338 
 
Primary Sponsor  
Name  MES DENTAL COLLEGE and HOSPITAL 
Address  MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 Palachode PO Kolathur via Perinthalmanna Malappuram Kerala 
Type of Sponsor  Other [Private Dental College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepthy A Bhaskar  MES Dental College , Perinthalmanna  MES Dental College and Hospital Department Of Orthodontics Room no 7 Palachode PO Kolathur via Perinthalmanna Malappuram Kerala
Malappuram
KERALA 
8891656399

dr.deepthybhaskar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE MES Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed orthodontic treatment with first premolar extraction in patients with Angles Class I malocclusion.   Fixed orthodontic treatment with first premolar extraction in patients with Angles Class I malocclusion with expected duration of more than 12 months.  
Comparator Agent  Fixed orthodontic treatment without first premolar extraction in patients with Angles Class I malocclusion.  Fixed orthodontic treatment without first premolar extraction in patients with Angles Class I malocclusion with expected duration of less than or greater than 12 months. 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1 Patients with complete dentition apart from third molars
2 Patients in the age group 13 to 30 years
3 Patients with Angles Class I malocclusion indicated for fixed orthodontic treatment with MBT technique 0 022 prescription
4 Group 1 patients will include Patients with Angles Class I malocclusion indicated for fixed orthodontic treatment with therapeutic extraction of first premolar teeth in the maxillary arch
5 Group 2 patients with Angles Class I malocclusion indicated for fixed orthodontic treatment without therapeutic extraction in the maxillary arch
6 Patients should be having healthy gingival and periodontal status
7 Patients with no evidence of root resorption radiographically

 
 
ExclusionCriteria 
Details  1 Missing molars or any of the anterior teeth
2 Previous history of orthodontic treatment
3 Erupted or unerupted supernumeraries in the maxillary anterior segment Impacted canines and Endodontically treated teeth
4 Periodontitis or History of avulsion or replantation
5 History of bleaching
6 Presence of cysts tumors and other pathologies
7 History of prolonged treatment with systemic steroids and NSAIDs Systemic diseases including Diabetes mellitus or History of metabolic disorders
8 Congenital anomalies or History of facial trauma
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome to be measured will be the difference in external apical root resorption of maxillary incisors in Angle’s Class I malocclusion patients undergoing fixed orthodontic treatment with and without first premolar extraction radiographically.  Base line, In group 1 three months after anterior teeth retraction and in Group 2 one year after commencement of fixed orthodontic treatment , Post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome to be observed will be assessment of any change in the external apical root resorption with respect to duration of fixed orthodontic treatment.  T0 Pre-treatment
T1 For Group 1 patients, RVG will be taken 3 months after starting retraction of anterior teeth. For Group 2 patients, RVG will be taken 1 year after the commencement of fixed orthodontic treatment
T2 Post-treatment
 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/02/2025 
Date of Study Completion (India) 30/05/2025 
Date of First Enrollment (Global)  09/02/2025 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="10"
Days="4" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to dr.deepthybhaskar@gmail.com

  6. For how long will this data be available start date provided 09-02-2025 and end date provided 28-02-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

A comparative radiographic evaluation of external apical root resorption of maxillary incisors in Angle’s Class I malocclusion patients undergoing fixed orthodontic treatment with and without first premolar extraction- a Prospective Cohort Study.

INTRODUCTION

External apical root resorption (EARR) is an undesirable pathological consequence of orthodontic tooth movement. During orthodontic treatment, mechanical forces are applied to move teeth and this results in a sterile, local inflammatory response which is complicated and has all characteristic inflammatory symptoms. Detection of EARR can be done clinically using two- dimensional (2D) radiography or three- dimensional (3D) cone beam computed tomography (CBCT). Even if CBCT is best clinical method for detection, it is costly and associated with a high dose of ionized radiation as observed by Samandara et al. However, periapical radiographs are part of the initial and final orthodontic records and can show different degrees of root resorption. This makes periapical radiographs a widely used complementary examination for root resorption evaluation in the clinical routine and research.

The presence and pattern of extractions is anticipated to play a significant role in orthodontically-induced inflammatory root resorption when compared with non-extraction treatment. Significant correlation was observed in the extraction groups between root resorption degree and amount of overjet correction and retraction of maxillary incisor apex. Extraction subjects generally require larger tooth movement and apical  displacement in order to correct malocclusions which results in more resorptive activity at the apical region. This may cause greater amount of EARR and a higher percentage of teeth with clinically significant resorption.  The purpose of the study is to evaluate the effect of fixed orthodontic treatment on external apical root resorption of maxillary incisors in Angle’s Class I malocclusion patients with and without first premolar extraction. 

RATIONALE OF THE STUDY

Different studies have been undertaken to evaluate correlation between external apical root resorption with treatment-related factors and patient-related factors. But most of the studies were of a retrospective study design. Treatment - related factors include treatment duration, direction of tooth movement, magnitude and method of force application, amount of apical displacement, etc. and patient related risk factors include genetics, biologic and systemic factors, age, sex, ethnicity, medications, hormones, tooth root morphology, previous history of trauma, root resorption or endodontic treatment etc. Therefore, this study is done to compare and evaluate the degree of external apical root resorption of the maxillary incisors in patients with Angle’s Class I malocclusion undergoing fixed orthodontic treatment with and without first premolar extraction reporting to the Department of Orthodontics and Dentofacial Orthopedics, MES Dental College, Perinthalmanna.

RESEARCH QUESTION

Is there any difference in the severity of external apical root resorption of maxillary incisors evaluated using RVG in patients aged 13-30 years undergoing comprehensive orthodontic treatment for the correction of Angle’s Class I malocclusion with and without first premolar extraction in the Department of Orthodontics and Dentofacial Orthopedics, MES Dental College, Perinthalmanna from June 2023 – March 2025?

AIM

The aim of the study is radiographic evaluation of external apical root resorption of maxillary incisors in Angle’s Class I malocclusion patients undergoing fixed orthodontic treatment with and without first premolar extraction.

  INCLUSION CRITERIA

1.     Patients with complete dentition apart from third molars

2.     Patients in the age group 13 – 30 years.

3.      Patients with Angle’s Class I malocclusion indicated for fixed orthodontic treatment with MBT technique 0.022” prescription.

4.     Group 1 patients will include Patients with Angle’s Class I malocclusion indicated for fixed orthodontic treatment with therapeutic extraction of first premolar teeth in the maxillary arch.

5.     Group 2 patients with Angle’s Class I malocclusion indicated for fixed orthodontic treatment without therapeutic extraction in the maxillary arch.

6.     Patients should be having healthy gingival and periodontal status. 

7.     Patients with no evidence of root resorption radiographically.

 

 EXCLUSION CRITERIA

1.     Missing molars or any of the anterior teeth

2.     Previous history of orthodontic treatment

3.     Erupted or unerupted supernumeraries in the maxillary anterior segment, Impacted canines and Endodontically-treated teeth

4.     Periodontitis or History of avulsion or replantation

5.     History of bleaching

6.     Presence of cysts, tumors and other pathologies

7.     History of prolonged treatment with systemic steroids and NSAIDs, Systemic diseases including Diabetes mellitus or History of metabolic disorders

8.     Congenital anomalies or History of facial trauma

       


 
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