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CTRI Number  CTRI/2018/12/016573 [Registered on: 10/12/2018] Trial Registered Prospectively
Last Modified On: 04/12/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study On The Performance Of The Tooth Jewel. 
Scientific Title of Study   To Assess And Compare The Clinical Performance Of Tooth Jewel Luted With Three Commercially Available Flowable Composites In Young Adults – A Randomised Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Purabi Edbor 
Designation  Post Graduate Student 
Affiliation  VSPM Dental College and Research Centre, Nagpur 
Address  Department of Conservative Dentistry and Endodontics, Vidya Shikshan Prasarak Mandal Dental College and Research Centre, Digdoh Hills ,Hingna Road , Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  7038917303  
Fax    
Email  purabiedbor@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratima Shenoi 
Designation  Guide and HOD 
Affiliation  VSPM Dental College and Research Centre, Nagpur 
Address  Department of Conservative Dentistry and Endodontics, Vidya Shikshan Prasarak Mandal Dental College and Research Centre, Digdoh Hills ,Hingna Road , Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  9822220506  
Fax    
Email  prshenoi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Purabi Edbor 
Designation  Post Graduate Student 
Affiliation  VSPM Dental College and Research Centre, Nagpur 
Address  Department of Conservative Dentistry and Endodontics, Vidya Shikshan Prasarak Mandal Dental College and Research Centre, Digdoh Hills ,Hingna Road , Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  7038917303  
Fax    
Email  purabiedbor@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Dr Purabi Edbor 
Address  Flat 101 A Square Apartments , 71, Abhyankar Nagar , Nagpur ,440010. 
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 Purabi Edbor  VSPM Dental College & Research Centre .  Department of Conservative Dentistry and Endodontics , Digdoh Hills, Hingna Road Nagpur: 440019 Maharashtra, India
Nagpur
MAHARASHTRA 		 7038917303

purabiedbor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VSPM Dental College and Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human volunteers willing to get a tooth jewel for enhancing their smile. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Flowable composites  G-aenial Universal Flo Filtek Supreme Flow Plus Tetric EvoFlow. 
Intervention  Tooth jewel cementation with the help of flowable composites.  3 flowable composites are used : G-aenial Universal Flo Filtek Supreme Flow Plus Tetric EvoFlow. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. Patients belonging to age group of 18-35 years .
2. Self motivated patients who are interested in getting a tooth jewel to enhance their
smile.
3. Caries free oral cavity.
4. Sound canine.
5. Patient not having a traumatic bite.
6. Patients not having any prosthesis associated with the canine. 
 
ExclusionCriteria 
Details  1. Patients with high caries index.
2. Patients with poor oral hygiene.
3. Carious canine.
4. Prosthesis with canine.
5. Traumatic bite. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the clinical performance ( Marginal integrity , marginal discolouration and retention )of tooth
jewel luted with three commercially available flowable composites 		 1st month , 3rd month and 6th month. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare the marginal integrity and marginal discolouration associated with the three commercially available flowable composites used for luting the tooth jewel .  1st month , 3rd month and 6th month. 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   19/12/2018 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

INTRODUCTION :

Aesthetics has become an important aspect of dentistry over the past few years and has led to the development of newer materials and techniques. Today people ,especially adolescents are becoming increasingly self conscious about their appearance and are trying various forms of body art. One such cosmetic procedure to add a spark to their smile is Tooth Jewellery. Tooth jewellery is a cosmetic dental procedure where a diamond or a stone is attached to the surface of the teeth .

 There is a scarcity of data regarding the clinical performance of tooth jewellery currently .This clinical trial will be evaluating and comparing the longevity of tooth jewel in the oral cavity. It will also throw some light on marginal discoloration and integrity of the flowable composites that will be used to fix the jewel on the surface of the teeth.

 

PRIMARY RESEARCH QUESTION : To assess and compare the clinical performance of tooth jewel luted with three commercially available flowable composites in young adults .

 

STUDY DESIGN : Randomised Controlled Trial .

 

STUDY SETTING : Department of Conservative Dentistry and Endodontics.

 

STUDY POPULATION : Adult population belonging to the age group of18-35 years in Central India as per the inclusion and exclusion criteria.

 

SAMPLE SIZE : N = 75

 

n = 25 ( 25 in each group)

 

PROCEDURE : Approval from the Institutional Ethical Committee will be obtained.

Self motivated patients from the adult population will be selected for the study.

Participants will be randomly assigned to one of the three groups using computer generated numbers.

Written informed consent will be taken from the patient.

 

- The tooth will be cleaned with a fluoride-free polishing paste.

- The tooth will be completely dried and isolated.

- Tooth will be etched with 3M Espe Scotchbond Etchant for about 20-30 seconds.

- The surface will be rinsed thoroughly with water and blow dried for 10 seconds.

- A light-cure bonding agent (3M Espe AdperScotchbond Multipurpose plus) will be applied , left for a maximum of 20 seconds .

- Then it will be light-cured for 20 sec.

- A small amount of respective flowable composite will be applied to the labial

surface of the tooth.

- Jewel will be picked up and pressed into the centre of composite.

- Slight adjustment of the jewel positioning will be done.

- Curing of composite will be done from the top for about 60 seconds, from the sides for a few seconds and from the back for another 60 seconds making sure the composite hardens evenly.

- Total curing time will be approximately 180 seconds.

- The total time for jewel to set into the composite is 20 sec.

- It will take about 4 minutes to safely affix the jewel.

- Pre and post procedural photographs will be taken.

- Post operative instructions will be given.

- The patient will be recalled after 1 month, 3 months and 6 months for clinical evaluation regarding marginal integrity, discolouration of flowable composites and longevity of tooth jewel.

- Post-operative evaluation will be carried out using the Modified United States Public Health Service (USPHS) Ryge criteria.

 

RESULTS : Awaited.

 
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