| 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
|
|
|
Primary Sponsor
|
| Name |
MES DENTAL COLLEGE PERINTHALMANNA |
| Address |
MES DENTAL COLLEGE PERINTHALMANNA
|
| Type of Sponsor |
Other [PRIVATE DENTAL COLLEGE] |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |