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CTRI Number  CTRI/2024/03/064287 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 15/03/2024
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative assessment of clinical usefulness of 2 proximal finishing systems 
Scientific Title of Study   Clinical Evaluation Of Two Proximal Contour Finishing Systems. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSusila Anand  
Designation  HOD 
Affiliation  Madha Dental College 
Address  Room number 5 Department of conservative dentistry and endodontics Madha dental college , madha nagar , kundrathur, chennai

Kancheepuram
TAMIL NADU
600069
India 
Phone  7273901234  
Fax    
Email  drsusila2000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSusila Anand  
Designation  HOD 
Affiliation  Madha Dental College 
Address  room number 5 Department of conservative dentistry and endodontics Madha dental college , madha nagar , kundrathur, chennai


TAMIL NADU
600069
India 
Phone  7273901234  
Fax    
Email  drsusila2000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  R, Loshini 
Designation  PG student 
Affiliation  Madha Dental College 
Address  Room number 5 Department of conservative dentistry and endodontics Madha dental college , madha nagar , kundrathur, chennai

Chennai
TAMIL NADU
600069
India 
Phone  7273901234  
Fax    
Email  loshiniraj20@gmail.com  
 
Source of Monetary or Material Support  
Madha Dental College  
 
Primary Sponsor  
Name  DrLoshini 
Address  Room number 5 Department of conservative dentistry and endodontics Madha Dental College Chennai 
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 V Susila Anand  Madha Dental College   Room number 5 Department of conservative dentistry and endodontics Madha Nagar, kundrathur, chennai 600069
Kancheepuram
TAMIL NADU 
7273901234

drsusila2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Madha Dental College and Hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Finishing and polishing Sofu Supersnap Rainbow kit  15 minutes the Shofu discs were used according to the color coded grits (Black – Coarse; Violet – Medium; Green – Fine; Red – Superfine) to achieve a polished and contoured interproximal surface using a low speed contra angle handpiece. Patients are evaluated on the day of restoration and 10 days follow- up 
Comparator Agent  finishing polishing Profin system and Shofu   Profin reciprocating system has smooth, glare-free surface, and a miniature head for best access into incapacious areas. The oscillating, controlled impact movement of the inserts can carefully, precisely, and safely grind, finish, and polish natural dentition and all types of restoration materials. The Profin instrument was used with a series of Lamineer diamond-coated metal tips which are Safe-sided to prevent damage to adjacent tissue or enamel. Its is used in the abrasive order over the proximal areas to attain proper polished surface. The Patients are evaluated on the day of restoration and 10 days follow up.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Any proximal restoration of vital and non-vital teeth.
2.Age group – 15 to 70 years
3.Gender – Male and Female
4.Supragingival caries
5.Permanent dentition
 
 
ExclusionCriteria 
Details  1.Unerupted or partially erupted teeth
2.Patients with bruxism habit
3.Teeth with Diseased pulp
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
finishing and polishing system for proximal composite restoration  Baseline, 10 days 
 
Secondary Outcome  
Outcome  TimePoints 
finishing & polishing system for proximal composite restoration  10 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   30/03/2024 
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="8"
Days="30" 
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  

The key to aesthetics and bio-integration of composite restorations lies in the final step of finishing and polishing. To achieve a successful restoration, it is important to maintain a smooth surface. Ideal finishing and polishing of restorations improves aesthetics and maintains the oral health of a patient. A rough surface serves as a site for bacterial adhesion, accumulates plaque, causes irritation to the gingiva, and results in periodontal diseases. Increased microleakage can cause staining at restoration margins, sensitivity, and secondary caries formation. Therefore finishing and polishing plays an important role in clinical restorative procedure. This procedure involves a sequential use of instruments with a progressive decrease in abrasiveness to achieve a highly smooth surface. Profin reciprocating system is specially designed for polishing proximal restorations. It has tactile ergonomics, smooth, glare-free surface, and a miniature head for best access into incapacious areas. The oscillating, controlled impact movement of the inserts can carefully, precisely, and safely grind, finish, and polish natural dentition and all types of restoration materials. The other group is Shofu Supersnap Rainbow Technique Kit is designed for finishing of all surfaces which can be adapted to finish the proximal surface. This study is evaluated using modified RYDGE criteria on the day of restoration and 10 days followup.

 

 
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