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
|
|
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
|
|
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 |