| CTRI Number |
CTRI/2020/12/029660 [Registered on: 09/12/2020] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of salivary biomarkers during fixed appliance treatment |
|
Scientific Title of Study
|
Evaluation of salivary biomarkers in orthodontic patients with recent and healed extraction sites during enmasse retraction - A pilot 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 Vinay Kumar Chugh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Room number-210, OPD block-2nd floor, Department of Dentistry, Basni-2 AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996704 |
| Fax |
|
| Email |
drvinaychd@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Kumar Chugh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Room number-210, OPD block-2nd floor, Department of Dentistry, Basni-2 AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996704 |
| Fax |
|
| Email |
drvinaychd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaghela Niraj Himmatlal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Room number-210, OPD block-A, 2nd floor, Department of Dentistry, Basni-2 AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996704 |
| Fax |
|
| Email |
drnirajvaghela@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Jodhpur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
Basni Industrial Area 2 AIIMS Jodhpur Rajashtan - 342005 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinay Kumar Chugh |
All India Institute Of Mediacal Sciences, Jodhpur |
Room no - 210, Block-A, Second floor, Department of Dentistry, All India Institute of Medical Sciences, Jodhpur Rajasthan 342005
Jodhpur
RAJASTHAN |
8003996704
drvinaychd@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M264||Malocclusion, unspecified, (2) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healed extraction sites in orthodontic patients |
Retraction of anterior teeth following extraction of upper or lower first premolar ( initiation of retraction forces after 3 months of extraction with completely healed extraction sites) |
| Intervention |
Recent extraction sites in orthodontic patients |
Retraction of anterior teeth immediately following extraction of upper or lower first premolar ( initiation of retraction forces on the same day of extraction) |
|
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Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient requiring extraction of 4 premolars for correction(class II div.1 malocclusion, Bimaxillary protrusion)
2) Patient above 12 years of age
3) Need for fixed appliance therapy involving tooth extractions, good general and periodontal health
4) Good oral hygiene
5) Full permanent dentition including the
maxillary second molars |
|
| ExclusionCriteria |
| Details |
1) Pregnancy and lactation
2) Patients who would not give informed consent
3) Patients consuming alcohol or tobacco use.
4) Any systemic condition that could affect periodontal status
5) Previous history of orthodontic treatment
6) Patient with disorders of bone metabolism (e.g., osteoporosis, gastrointestinal diseases related to nutrition and mineral metabolism, endocrine diseases, immunologic disorders, and connective tissue diseases)
7) Patient already under medication for treatment of conditions like heart conditions, joint replacements, hormonal or bisphosphonate antiresorptive therapies, and chronic therapy with heparin or corticosteroids.
8) Patients with developmental anomalies like, cleft lip and palate and other craniofacial abnormalities |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Salivary levels of RANKL and OPG will be measured through an ELISA-based capture assay by using the commercial kits (Bioassay™ technology laboratory) HUMAN RANKL ELISA and OPG ELISA (At Biochemistry laboratory, AIIMS JODHPUR) following the manufacturer’s instructions |
concentration will be measured in these time points; before bonding (T0), after levelling and alignment and just before application of retraction force (T1), 2 weeks after application of retraction force (T2), 6-7 weeks after application of retraction force (T3) and 10-11 weeks after application of retraction force |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of tooth movement will be calculated clinically, in terms of distance between cusp tip of maxillary canines and mesiobuccal cusp tips of maxillary first molars, with the help of vernier caliper |
Alginate impression will be taken at given time poins before bonding (T0), after levelling and alignment and just before application of retraction force (T1), 2 weeks after application of retraction force (T2), 6-7 weeks after application of retraction force (T3) and 10-11 weeks after application of retraction force |
|
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Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/12/2020 |
| Date of Study Completion (India) |
15/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The aim of the study is to evaluate salivary biomarkers (RANKL/OPG) in orthodontic patients with recent and healed extraction sites during enmasse retraction. Patients will be randomly allocated into two groups using computer generated randomization scheme: Group 1: Orthodontic force application in recent extraction sites Group 2: Orthodontic force application in healed extraction sites
Method After recruitment of patients based on inclusion and exclusion criteria baseline salivary samples will be collected from each patient before bonding (T0). Whole saliva will be processed for clarification by centrifugation. Salivary levels of RANKL and OPG will be measured through an ELISA-based capture assay by using the commercial kits for RANKL human ELISA and OPG ELISA For Group 1 – Initial Leveling and Alignment will be performed first without extraction of 1st premolar. Once the patient reaches to 019x25 SS as final alignment wire, salivary samples will be collected (T1).Extraction of 1st premolar will be carried out and on the same day retraction force will be applied. Patient will be recalled for collection of samples of unstimulated whole saliva 2 weeks after application of retraction force (T2), 6-7 weeks after application of retraction force (T3) and 10-11 weeks after application of retraction force (T4). 13) For Group 2 – Extraction of 1st Premolar will be done before Leveling and Alignment i.e immediately after bonding. Once the patient reaches to 019x25 SS as final alignment wire, salivary samples will be collected (T1). Orthodontic retraction force application will be started. Patient will be recalled for collection of samples of unstimulated whole saliva 2 weeks after application of retraction force (T2), 6-7 weeks after application of retraction force (T3) and 10-11 weeks after application of retraction force (T4). Level of salivary markers and rate of tooth movement will be then evaluated in the two groups.
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