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CTRI Number  CTRI/2025/01/079665 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 26/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Evaluation of difference in the rate of tooth movement using TiO2 nanoparticles coated orthodontic wire and conventional orthodontic wire with the help of biomarkers 
Scientific Title of Study   Clinical Evaluation of difference in the rate of retraction using TiO2 nanoparticles coated orthodontic wire and conventional orthodontic wire with the help of biomarkers- a split-mouth study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aparna A V 
Designation  Junior resident , Post graduate 
Affiliation   
Address  Faculty of dental sciences,Institute of medical sciences,,Banaras hindu university,Varanasi.

Varanasi
UTTAR PRADESH
221005
India 
Phone  9446130647  
Fax    
Email  aparnavelimukku@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Thakur Prasad Chaturvedi 
Designation  Senior Professor 
Affiliation   
Address  Faculty of dental sciences, Institute of medical sciences, Banaras hindu university, Varanasi.

Varanasi
UTTAR PRADESH
221005
India 
Phone  9451570848  
Fax    
Email  tpchaturvedident@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Aparna A V 
Designation  Junior resident, Post graduate 
Affiliation   
Address  Faculty of dental sciences,Institute of medical sciences,,Banaras hindu university,Varanasi.

Varanasi
UTTAR PRADESH
221005
India 
Phone  9446130647  
Fax    
Email  aparnavelimukku@gmail.com  
 
Source of Monetary or Material Support  
Faculty of dental sciences,Institute of medical sciences,,Banaras hindu university,Varanasi.221005 
 
Primary Sponsor  
Name  Aparna A V 
Address  Faculty of dental sciences,Institute of medical sciences,,Banaras hindu university,Varanasi.221005 
Type of Sponsor  Other [Self] 
 
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 
Dr Thakur prasad Chaturvedi  Faculty of dental sciences,Institute of medical sciences,,Banaras hindu university.  Unit of orthodontics and dentofacial orthopaedics.
Varanasi
UTTAR PRADESH 		 9451570848

tpchaturvedident@bhu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethics Committee, Institute of medical sciences, Banaras hindu university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with Class 1 bimaxillary protrusion who needs upper premolars extractions. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TiO2 coated archwire  Half portion of 19*25 rectangular archwire is coated with TiO2 nanoparticles by sol gel dip method. rate of tooth movement is compared with uncoated side by measuring IL-1 beta and Tnf-alpha in GCF. 
Comparator Agent  uncoated side of archwire  Part of 19*25 Rectangular archwire left intact. levels of il-1 beta and Tnf-alpha in GCF is measured and also the rate of canine movement while retraction using partly TiO2 coated and partly uncoated wire 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1.Patients requiring maxillary premolars extractions.
2.Good systemic health.
3.Not on Antibiotic therapy within last 6 months.
4.No use of antiinflammatory drug in a month preceding the study.
5.Healthy periodontium with probing depth less tha or equal to 3mm and no bone less radiographically. 
 
ExclusionCriteria 
Details  1.systemic diseases or syndromes.
2.Long term anti inflammatory medication
3.History of previous orthodontic treatment.
4.Parafunctional habits
5.Grossly decayed teeth.
6. Facial asymmetry and TMJ dysfunction.
7.Extracted or missing permanent teeth. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Level of IL-1 beta AND TNF-Alpha in GCF.  24 hours, 7th day and 21st day GCF samples during canine retraction period. 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of tooth movement in test & control sides.  RATE OF CANINE MOVEMENT IN TEST AND CONTROL SIDES DURING RETRACTION PERIOD. 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   15/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/03/2025 
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   Sliding a tooth along an orthodontic wire is the common clinical procedure in these phases. Whenever sliding occurs, a frictional force is generated between the wire and the orthodontic bracket. In the case of orthodontic mechanotherapy, a biological tissue response will occur only when the applied force adequately overcomes the friction at the bracket-wire interface. High frictional forces will affect the system severely, and this leads to the extension of treatment time, or the outcome become compromised because of little or no movement. The surface topography of an archwire can affect its mechanical characteristics, corrosion behavior, friction, aesthetic appearance, and biocompatibility. The retarding frictional force develops due to the surface roughness of the archwire. Nanoengineering based surface modification can be used to reduce the surface roughness of orthodontic wires.. A recent study regarding the surface modification of orthodontic wires with TiO2 nanoparticles has shown better surface characteristics and reduction in frictional forces. GCF reflects the degree of cellular activities during orthodontic tooth movement and carries a multitude of inflammatory mediators involved in the bone and soft tissue remodeling process. Some studies have shown that leveling and distalization of teeth evoke an increase in both IL-1 and TNF-α that can be detected in GCF. This particular study compares the rate of tooth movement and also measures the amount of cytokines released, particularly IL-1 beta and TNF-α in GCF while using TiO2 coated and uncoated orthodontic wire for canine retraction. 
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