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CTRI Number  CTRI/2025/08/093875 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study on Body Chemicals and Root Changes During Backward Tooth Movement Using Different Braces Methods 
Scientific Title of Study   Analysis of Interleukin-1 Receptor Antagonist Levels and Orthodontic Root Resorption During Retraction with Nickel Titanium Closed Coil Springs and Active Tiebacks: 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  Sreelakshmi V 
Designation  PG Student 
Affiliation  MES Dental College and Hospital 
Address  Dept of Orthodontics PG Division Room no 7 MES Dental College Palachode P O Kolathur via Perinthalmanna

Malappuram
KERALA
679321
India 
Phone  8281453235  
Fax    
Email  sreelakshmi.vijayan96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Muhamed Shaloob 
Designation  Professor 
Affiliation  MES Dental College and Hospital 
Address  Dept of Orthodontics Room no 7 MES Dental College Palachode P O Kolathur via Perinthalmanna

Malappuram
KERALA
679321
India 
Phone  9746277277  
Fax    
Email  shaloobdr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sreelakshmi V 
Designation  PG Student 
Affiliation  MES Dental College and Hospital 
Address  sreelakshmi house Hill view nagar line no 5 Perumbadari P O Mannarkkad
Dept of Orthodontics MES Dental College Palachode P O Kolathur via Perinthalmanna pin 679321
Malappuram
KERALA
678762
India 
Phone  8281453235  
Fax    
Email  sreelakshmi.vijayan96@gmail.com  
 
Source of Monetary or Material Support  
MES Dental College and Hospital Palachode P O Kolathur Via Perinthalmanna 679321  
 
Primary Sponsor  
Name  MES Dental College and Hospital 
Address  MES Dental College and Hospital Palachode P O Kolathur Via Perinthalmanna 679321  
Type of Sponsor  Other [Private Dental College and Hospital] 
 
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 Sreelakshmi V  MES Dental College and Hospital  Department of Orthodontics PG Division Room no 7 Malappuram Kerala
Malappuram
KERALA 
82814 53235

sreelakshmi.vijayan96@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: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active Tie Back  Retraction of teeth using Active Tie Back with expected duration of 1 year 
Intervention  Nickel Titanium Closed Coil Spring  Retraction of teeth using Nickel-Titanium (NiTi) Closed Coil Springs with expected duration of 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patients with complete dentition and Angle’s Class I Bimaxillary protrusion
Patients in the age group of 18 to 25 years
Patients should have no radiographic sign of root resorption
Patients should have healthy gingival and periodontal status
 
 
ExclusionCriteria 
Details  Missing molars or any anterior teeth
Previous history of ortho treatment
Erupted or unerupted supernumeraries in the maxillary anterior segment
Impacted canines, Endodontically treated teeth
Upper anterior crowding greater than or equal to 4mm
Periodontitis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the correlation between changes in interleukin-1 receptor antagonist (IL-1RA) levels in gingival crevicular fluid (GCF) and the severity of orthodontic root resorption (ORR) in patients undergoing space closure.  T0 Before treatment
T1 6 months after start of treatment
T2 End of space closure 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the differences in duration of retraction under two orthodontic mechanics with NiTi closed coil springs and active tiebacks  T0 Before treatment
T1 6 months after start of treatment
T2 End of space closure 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   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 - Proposals should be directed to [sreelakshmi.vijayan96@gmail.com].

  6. For how long will this data be available start date provided 04-09-2025 and end date provided 23-02-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

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

TITLE

Analysis of Interleukin-1 Receptor Antagonist Levels and Orthodontic Root Resorption During Retraction with Nickel Titanium Closed Coil Springs and Active Tiebacks: A Prospective Cohort Study

INTRODUCTION, RATIONALE, RELEVANCE

Orthodontic tooth movement is a highly orchestrated biological process driven by mechanical forces, leading to bone remodeling through the activation of inflammatory and immunological pathways in the periodontal ligament (PDL) and alveolar bone. Apical root resorption is a common occurrence during orthodontic tooth movement, varying in severity and often considered an unavoidable aspect of treatment. If left unchecked, severe root resorption can compromise the long-term prognosis of the affected teeth. Moreover, previous studies by Lupi JE et al have noted that incisors are more affected than posterior teeth.

Orthodontic mechanics influences the extent of root resorption. The second stage of comprehensive fixed orthodontic treatment, space closure, is a complex process focused on achieving normal occlusion by correcting molar and buccal segment relationships, closing extraction spaces, and addressing overjet issues. Active tie-back mechanics are employed for space closure and controlled tooth movement in orthodontic treatment after premolar extraction. Similarly, NiTi (nickel-titanium) wires are widely used in orthodontics due to their superior flexibility and consistent force delivery, which promote efficient tooth movement. NiTi closed coil springs demonstrated a faster rate of space closure and anchorage loss compared to active tiebacks.

Traditionally, orthodontic root resorption (ORR) is assessed using panoramic or periapical radiographs. However, these two-dimensional imaging techniques are limited in detecting early stages of resorption, as significant root length reduction is necessary for changes to appear on the radiographs. This highlights the need for more sensitive and advanced diagnostic methods to identify ORR at an earlier stage. The search for a safe and effective method to diagnose and monitor ORR has gained significant attention, leading to numerous studies exploring gingival crevicular fluid (GCF) as a source of biomarkers.

According to Rody et al, Interleukin-1 receptor antagonist (IL-1RA) is an anti-inflammatory cytokine that regulates inflammatory processes and prevents bone resorption by counteracting the effects of interleukin-1 (IL-1). The decreased levels of IL-1RA in resorbing teeth suggest its potential as a valuable biomarker for detecting root resorption. This study underscores the critical role of IL-1RA in periodontal tissue remodelling, offering significant insights into its involvement in resorption-related activities and its implications for orthodontic treatment strategies. This raises the possibility that IL-1RA levels in gingival crevicular fluid (GCF) could serve as a biomarker for predicting and monitoring ORR severity during treatment.

There was another experimental animal study, specifically involving mice models which investigated the effect of the interleukin-1 receptor antagonist (IL-1RA) on orthodontic tooth movement (OTM). However a prospective cohort study that involves human beings have not yet been done to the best of my knowledge. NiTi coil springs and active tie-backs are utilized as they are two distinct retraction modalities, allowing for a comparative evaluation of the root resorption rate associated with each method.

 

The rationale for this study lies in its potential to elucidate the biological mechanisms linking IL-1RA with ORR and to identify new avenues for early detection and intervention. By analyzing changes in IL-1RA levels in GCF and correlating them with radiographic measures of ORR in patients undergoing space closure with NiTi closed coil springs and active tiebacks, this study seeks to provide a comprehensive understanding of how cytokine dynamics influence resorptive processes during orthodontic treatment. This diagnostic method holds great promise as it can eliminate the need for unnecessary exposure to radiation and shows potential for integration into routine dental care. In the long term, it could have a profound impact on the broader healthcare system.

 

NOVELTY

This study represents a novel approach to understanding the biological underpinnings of orthodontic root resorption (ORR) by focusing on the anti-inflammatory cytokine interleukin-1 receptor antagonist (IL-1RA). Unlike previous studies that primarily emphasize pro-inflammatory mediators such as interleukin-1 (IL-1) or clinical variables, this study highlights the protective role of IL-1RA and its potential as a biomarker for predicting ORR. Additionally, the prospective cohort study design allows for the longitudinal analysis of cytokine dynamics and their correlation with ORR severity. The study also compares IL-1RA levels and their association with ORR severity between two commonly used orthodontic mechanics, NiTi closed coil springs and active tiebacks, providing insights into their respective biological and mechanical impacts on tooth movement. Furthermore, the exploration of IL-1RA levels in gingival crevicular fluid (GCF) as non-invasive biomarkers introduces a promising avenue for early detection of orthodontic root resorption in patients reporting to the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College Perinthalmanna.


RESEARCH QUESTION

How do changes in interleukin-1 receptor antagonist (IL-1RA) levels in gingival crevicular fluid (GCF) compare with the severity of orthodontic root resorption (ORR) in patients with Angle’s Class I bimaxillary protrusion undergoing space closure with NiTi closed coil springs and active tiebacks, at 3 time points, in the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College, between 04/09/2025 and 31/2/2027?

 

AIM

To compare the changes in interleukin-1 receptor antagonist (IL-1RA) levels in gingival crevicular fluid (GCF) with the severity of orthodontic root resorption (ORR) using RVG at 3 time points in patients with Angle’s class I bimaxillary protrusion undergoing space closure with NiTi closed coil springs and active tiebacks, who report to the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College.


INCLSION CRITERIA

Patients with complete dentition and Angle’s Class I Bimaxillary protrusion

Patients in the age group of 18 to 25 years

Patients should have no radiographic sign of root resorption

Patients should have healthy gingival and periodontal status

EXCLUSION CRITERIA

Missing molars or any anterior teeth

Previous history of ortho treatment

Erupted or unerupted supernumeraries in the maxillary anterior segment

Impacted canines, Endodontically treated teeth

Upper anterior crowding greater than or equal to 4mm

Periodontitis 


 
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