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CTRI Number  CTRI/2025/11/097979 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 22/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Longitudinal Assessment of Dentin Sialoprotein and Interleukin-1 Receptor Antagonist in Gingival Crevicular Fluid and Their Relation with External Apical Root Resorption During Fixed Orthodontic Treatment 
Scientific Title of Study   Longitudinal Assessment of Dentin Sialoprotein and Interleukin-1 Receptor Antagonist in Gingival Crevicular Fluid and Their Relation with External Apical Root Resorption During Fixed Orthodontic Treatment. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAMESH C 
Designation  POSTGRADUATE STUDENT ,MDS ,ORTHODONTIST 
Affiliation  MES DENTAL COLLEGE ,PERINTHALMANNA 
Address  MES Medical College & Hospital Perinthalmanna, Kerala 679322 Department of orthodontics Room number 7
MES Medical College & Hospital Perinthalmanna, Kerala 679322 Department of orthodontics , Room number 7
Malappuram
KERALA
679322
India 
Phone  9744968893  
Fax    
Email  mesdentalcollege06@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vincy Antony 
Designation  Professor and HOD 
Affiliation  MES Dental College 
Address  Department of Orthodontics MES Dental College Malaparambu Palachode PO Perinthalmanna Malappuram
Department of Orthodontics MES Dental College Malaparambu Palachode PO Perinthalmanna Malappuram
Malappuram
KERALA
679321
India 
Phone  9846353153  
Fax    
Email  vincyantony2008@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  RAMESH C 
Designation  POSTGRADUATE STUDENT ,MDS ,ORTHODONTIST 
Affiliation  MES DENTAL COLLEGE ,PERINTHALMANNA 
Address  MES Medical College & Hospital Perinthalmanna, Kerala 679322 Department of Orthodontics Room Number 7
MES Medical College & Hospital Perinthalmanna, Kerala 679322

KERALA
679322
India 
Phone  9744968893  
Fax    
Email  rameshcarmel067@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  MES DENTAL COLLEGE PERINTHALMANNA 
Address  MES DENTAL COLLEGE PERINTHALMANNA  
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 
RAMESH C  MES DENTAL COLLEGE  ROOM NUMBER SEVEN DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS DIVISION TWO
Malappuram
KERALA 
09744968893

mesdentalcollege06@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MES DENTAL COLLEGE INSTITUSION ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Undergoing orthodontic treatment without any other diseases 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1 Patients with complete dentition in the age group 18 to 25 yrs
2 Patients should be having healthy gingival and periodontal status
3 Diagnosed with Angles Class I malocclusion with bimaxillary dentoalveolar protrusion requiring first premolar extraction as part of fixed orthodontic treatment
 
 
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.
4 Impacted canines and endodontically treated teeth.
• Patients with systemic diseases or conditions affecting oral health (e.g., diabetes, periodontal disease, or other chronic inflammatory conditions).
• History of avulsion or replantation.
• History of prolonged treatment with systemic steroids and NSAIDs.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the relationship between DSP and IL-1RA levels and the severity of external apical root resorption (EARR) at various stages of treatment.  There are significant changes in the levels of Dentin Sialoprotein (DSP) and Interleukin-1 Receptor Antagonist (IL-1RA) in gingival crevicular fluid (GCF) and the severity of external apical root resorption (EARR) assessed using RVG at three stages of fixed orthodontic treatment (pretreatment, six months, and one year after treatment initiation) in patients with Angle’s Class I malocclusion with bimaxillary dentoalveolar protrusion undergoing first premolar extraction and en-masse retraction 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the relationship between DSP and IL-1RA levels and the severity of external apical root resorption (EARR) at various stages of treatment  Gingival crevicular fluid (GCF) samples will be collected at three specific clinical time points. The first sample (T0) will be collected before bonding, the second sample (T1) will be collected 6 months after initiation of treatment, and the final sample (T2) will be collected one year after initiation of treatment 
 
Target Sample Size   Total Sample Size="9"
Sample Size from India="9" 
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)   05/02/2026 
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 - NO
Brief Summary  

External apical root resorption (EARR) is a common yet often undetected adverse effect of fixed orthodontic treatment. Despite its typically mild presentation, severe resorption can occur in certain patients, potentially compromising long-term dental health. Current diagnostic modalities, such as radiography, lack the sensitivity to detect early-stage resorption and cannot differentiate between active and inactive resorptive phases. As EARR is multifactorial and influenced by genetic, biological, and mechanical factors, there is a critical demand for accurate, non-invasive diagnostic markers to enable early detection and real-time monitoring of resorptive activity. Emerging evidence highlights the potential of biomarkers such as dentin sialoprotein (DSP) and interleukin-1 receptor antagonist (IL-1RA) in gingival crevicular fluid (GCF) as indicators of resorption severity. However, the variations in these biomarkers throughout fixed orthodontic treatment and their relationship to the severity of root resorption are not yet well understood.

This gap in knowledge underscores the necessity for research to establish the diagnostic utility of DSP and IL-1RA as biomarkers for predicting and assessing root resorption during orthodontic therapy.

Timely identification of teeth prone to severe resorption is essential. Although radiography is the most widely utilized diagnostic method, it has significant limitations, including its inability to identify early resorption stages or differentiate between active and inactive phases. Additionally, radiographic evidence of resorption becomes apparent only after substantial tissue loss, by which time irreversible damage may have occurred. These drawbacks highlight the urgent need for more sensitive, non-invasive, and timely diagnostic approaches.

Gingival crevicular fluid (GCF) has gained attention as a potential medium for identifying biochemical markers that reflect periodontal and resorptive activity. Dentin sialoprotein (DSP), a byproduct of dentin matrix breakdown, is a promising biomarker and has been identified in the GCF of patients undergoing fixed orthodontic therapy. Similarly, interleukin-1 receptor antagonist (IL-1RA), an anti-inflammatory cytokine, plays a pivotal role in regulating inflammatory responses and preventing excessive bone and root resorption. Variation in the concentration of these biomarkers during fixed orthodontic treatment may offer valuable insights into resorptive activity and susceptibility to EARR.

This study aims to address these unmet needs by investigating the dynamic changes in DSP and IL-1RA levels at three clinical time points to assess effect of treatment duration during fixed appliance therapy in patients with Angle’s Class 1 malocclusion with bimaxillary dentoalveolar protrusion who require all first premolar extraction followed by en-masse retraction, thereby identifying reliable, non-invasive biomarkers for early diagnosis and monitoring of EARR. Establishing such biomarkers could minimize reliance on radiography and enable timely interventions and personalized treatment adjustments, reducing the chance of significant root damage and enhancing long-term treatment outcomes.


 
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