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CTRI Number  CTRI/2024/08/072423 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluating the Effects of Gold Nanoparticle Coated Retainers on Oral Health Reduction of Harmful Bacteria and Improvement in Gum Health After 15 and 30 Days of Use 
Scientific Title of Study   Assessment of antimicrobial properties of gold nanoparticle coated thermoplastic orthodontic retainers and its influence on gingival health 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shreya Chinnawar 
Designation  Post Graduate student 
Affiliation  Krishna Vishwa Vidyapeeth 
Address  Dept of Orthodontics, School of Dental sciences, Krishna Vishwa Vidyapeeth, Malkapur, Karad.

Satara
MAHARASHTRA
415539
India 
Phone  9518350258  
Fax    
Email  33shreyachinnawar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandesh Phaphe 
Designation  Associate Professor 
Affiliation  Krishna Vishwa Vidyapeeth 
Address  Dept of Orthodontics, School of Dental sciences, Krishna Vishwa Vidyapeeth, Karad

Satara
MAHARASHTRA
415539
India 
Phone  7798256929  
Fax    
Email  sandeshphaphe2541@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shreya Chinnawar 
Designation  PG student 
Affiliation  Krishna Vishwa Vidyapeeth 
Address  Dept of Orthodontics, School of Dental sciences, Krishna Vishwa Vidyapeeth, Karad


MAHARASHTRA
415539
India 
Phone  9518350258  
Fax    
Email  33shreyachinnawar@gmail.com  
 
Source of Monetary or Material Support  
Krishna College of Pharmacy, KVV, Malkapur, Karad, MAharashtra, India. Pin code- 415110 
 
Primary Sponsor  
Name  Krishna Vishwa Vidyapeeth 
Address  School of Dental Sciences, KVV, Karad, MAharashtra, India. Pin code- 415110 
Type of Sponsor  Other [Deemed university] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
Not Applicable  N/A 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shreya Chinnawar  Krishna Vishwa Vidyapeeth  Dept Of Orthodontics, School of Dental Sciences, KVV, Karad
Satara
MAHARASHTRA 		 9518350258

33shreyachinnawar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee KIMSDU, Karad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A488||Other specified bacterial diseases, (2) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  "Gold Nanoparticle-Coated Orthodontic Retainers."  reating Gold Nanoparticles: Synthesizing GNPs from pomegranate peel extract. Coating Retainers: Applying these nanoparticles to thermoplastic orthodontic retainers. Surface Activation: Treating the retainers with UV light to enhance adhesion. Soaking in GNP Solution: Immersing the retainers in a GNP solution for 12 hours. 
Comparator Agent  "Standard Thermoplastic Orthodontic Retainers".  Uncoated Thermoplastic Orthodontic Retainers: These are standard retainers without the gold nanoparticle coating. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  The inclusion criteria for this study involve patients with permanent dentition who present with specific types of malocclusion. Eligible participants must have Class 1 malocclusion with spacing and crowding within the range of 2-3 mm, as well as those with Class 2 Division 1 malocclusion. This selection ensures a uniform group for evaluating the effects of gold nanoparticle-coated thermoplastic orthodontic retainers on oral and gingival health. 
 
ExclusionCriteria 
Details  Physically challenged patients.
Cleft lip and Palate.
Mentally challenged.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will evaluate gold nanoparticle-coated retainers for their effects on oral and gingival health and antimicrobial properties. We expect reductions in Porphyromonas gingivalis and Streptococcus mutans, improved gingival health, and positive feedback at 15 and 30 days. Comparative and statistical analyses will assess effectiveness and guide future research.  The time points for this study are:

Baseline (at retainer delivery)
15 days post-delivery
30 days post-delivery 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes of the study will focus on patient experience and overall health, including comfort and satisfaction with the retainers, any changes in taste perception, and sensory feedback. Patient compliance and ease of use will be monitored, along with any adverse reactions such as allergies or irritation. The aesthetic appeal and its impact on patient confidence will be assessed. Additionally, the study will evaluate the longevity and durability of the gold nanoparticle-coated retainers. These outcomes will provide insights into the practicality, patient acceptance, and overall effectiveness of the retainers in real-world use.  The secondary outcomes of the study will be assessed at multiple time points to gauge patient experience and overall health. Evaluations will be conducted at baseline, 15 days, and 30 days after retainer delivery. These assessments will include patient comfort and satisfaction, changes in taste perception, sensory feedback, compliance, ease of use, any adverse reactions, aesthetic appeal, and the longevity and durability of the retainers.






 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   24/08/2024 
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="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Aim of the study is  to analyze the effect of gold nanoparticles coated retainers on oral and gingival health and to check its antimicrobial properties.

Objectives of study are-

  1. To evaluate the antimicrobial property of gold nanoparticle coated Thermoplastic orthodontic retainer on Porphyromonas. gingivalis and Streptococcus mutans strains.
  2. To evaluate the effect of gold nanoparticle coated Thermoplastic orthodontic retainer on oral and gingival health at the interval of 15 days from the retainer delivery.
  3. To evaluate the effect of gold nanoparticle coated Thermoplastic orthodontic retainers on oral and gingival health at the interval of 30 days from the retainer delivery.
  4. To compare and analyze the results.
 
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