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CTRI Number  CTRI/2023/01/048742 [Registered on: 04/01/2023] Trial Registered Prospectively
Last Modified On: 19/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Diagnostic
Screening
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   "Evaluation of levels of biomarkers at different stages of orthodontic treatment" 
Scientific Title of Study   Evaluation and comparison of levels of matrix metalloproteinase-8, osteocalcin and alkaline phosphatase in gingival crevicular fluid at different stages of orthodontic treatment: An in-vivo study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rony T Kondody 
Designation  Assistant Professor 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences 
Address  Department of Orthodontics Sri Rajiv Gandhi College of Dental Sciences, 3rd Cross, Cholanagar, RT Nagar, Bangalore.
Sri Rajiv Gandhi College of Dental Sciences, 3rd Cross, Cholanagar, RT Nagar, Bangalore.
Bangalore
KARNATAKA
560032
India 
Phone  7760250619  
Fax    
Email  ronykondody55@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rony T Kondody 
Designation  Assistant Professor 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences 
Address  Department of Orthodontics Sri Rajiv Gandhi College of Dental Sciences, 3rd Cross, Cholanagar, RT Nagar, Bangalore.
Sri Rajiv Gandhi College of Dental Sciences, 3rd Cross, Cholanagar, RT Nagar, Bangalore.
Bangalore
KARNATAKA
560032
India 
Phone  7760250619  
Fax    
Email  ronykondody55@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rony T Kondody 
Designation  Assistant Professor 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences 
Address  Department of Orthodontics Sri Rajiv Gandhi College of Dental Sciences, 3rd Cross, Cholanagar, RT Nagar, Bangalore.
Sri Rajiv Gandhi College of Dental Sciences, 3rd Cross, Cholanagar, RT Nagar, Bangalore.
Bangalore
KARNATAKA
560032
India 
Phone  7760250619  
Fax    
Email  ronykondody55@gmail.com  
 
Source of Monetary or Material Support  
Rony T Kondody Department of Orthodontics Sri Rajiv Gandhi College of Dental Sciences, 3rd Cross Road Post, Chola Nagar, RT Nagar, Bengaluru, Karnataka 560032  
 
Primary Sponsor  
Name  Rony T Kondody 
Address  Department of Orthodontics Sri Rajiv Gandhi College of Dental Sciences, 3rd Cross Road Post, Chola Nagar, RT Nagar, Bengaluru, Karnataka 560032 
Type of Sponsor  Other [Self sponsored] 
 
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 
Rony T Kondody  Sri Rajiv Gandhi College of Dental Sciences  Sri Rajiv Gandhi College of Dental Sciences, 3rd Cross Road Post, Chola Nagar, RT Nagar, Bengaluru, Karnataka 560032
Bangalore
KARNATAKA 
7760250619

ronykondody55@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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 
Comparator Agent  levels of biomarker  Split Mouth Design with respect to MOPs and also the difference in levels of biomarker level at different stages of orthodontic treatment is evaluated 
Intervention  Micro-osteoperforation (MOPs)  Micro-osteoperforation (MOPs)accelerating the rate of Orthodontic tooth Movement 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  22.00 Year(s)
Gender  Both 
Details  The inclusion criteria will include, patients requiring first premolar extraction cases,
cases which belong to Angles’ Class I bimaxillary, Class II Div 1 malocclusion (ANB ≤
5degree), mandibular incisor irregularity of 4–6 mm, good oral conditions with no bleeding
on probing and also with no radiographic evidence of periodontal bone loss after the
radiographic periapical examination 
 
ExclusionCriteria 
Details  Patients who are taking various anti-inflammatory drugs, also patients with various local and general systemic conditions which could influence the levels of biomarkers  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.levels of Matrix Metalloproteinase-8, Osteocalcin, and alkaline
phosphatase in GCF during the initial leveling and alignment stage by using two different
archwires.
2. levels of Matrix Metalloproteinase-8, Osteocalcin, and alkaline
phosphatase in GCF during initial space closure with and without micro-osteoperforation
using the split-mouth design.
3. To compare rate of retraction between the conventional and micro
osteoperforation groups in the digital model using the split-mouth design.
4. Compare the levels of Matrix Metalloproteinase-8, Osteocalcin, and alkaline
phosphatase in GCF at debonding stage and after 6 months of the retention period. 
4 years 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate levels of matrix metalloproteinase-8, osteocalcin, and alkaline phosphatase in gingival crevicular fluid at different stages of orthodontic treatment  4 years 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   15/01/2023 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The orthodontic tooth movement is a complex mechanism, that involves interactions between various cells of the periodontal ligament, and alveolar bone, as well as multiple intercellular actions. These forces of tooth movement produce an environment that is described as a continuous sequence of inflammation and repair designed to restore normal tissue continuity and function. The mechanisms responsible for converting orthodontic force into cellular responses, including cellular differentiation, at present, remain an area of ambiguity. It has been observed that markers of bone remodeling are found in GCF. Therefore, it has been shown that GCF may reflect the immune and inflammatory reactions arising from the application of orthodontic force. While studying the levels of biomarkers in the GCF of patients undergoing OTM, one of the main drawbacks observed in orthodontics was the longer duration of orthodontic treatment as they pose various disadvantages such as root resorption, gingival inflammation, enamel decalcification, etc. Accelerated orthodontics has gained popularity in recent years and it has been proposed to accelerate orthodontic tooth movement. Further, studies regarding the levels of various biomarkers in the human GCF at the various stages of orthodontic treatment like the initial phase of levelling and alignment, the initial stages of space close and debonding phase, and their association with clinical outcomes. Therefore the purpose of this study is to evaluate levels of matrix metalloproteinase-8, osteocalcin, and alkaline phosphatase in gingival crevicular fluid at different stages of orthodontic treatment
 
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