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CTRI Number  CTRI/2025/06/088848 [Registered on: 13/06/2025] Trial Registered Prospectively
Last Modified On: 13/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Dental Tools for Caries removal: Regular Mirror, Magnified Mirror, and Loupes. 
Scientific Title of Study   Comparative evaluation of class 1 cavity preparation using magnified mouth mirror, loupes and conventional mouth mirror: A Randomized Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shaik Sameera 
Designation  Post graduate student 
Affiliation  Narayana Dental College and Hospital  
Address  Department of Paediatric and Preventive Dentistry Division-7 Room number-7 Narayana Dental College and Hospital Chinthareddypalem Nellore Andhra pradesh Nellore ANDHRA PRADESH 524003 India

Nellore
ANDHRA PRADESH
524003
India 
Phone  8919116647  
Fax    
Email  shaiksameera2407@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sivakumar Nuvvula  
Designation  Professor and Head of the Department  
Affiliation  Narayana Dental College and Hospital  
Address  Department of Paediatric and Preventive Dentistry Division-7 Room number-7 Narayana Dental College and Hospital Chinthareddypalem Nellore Andhra pradesh Nellore ANDHRA PRADESH 524003 India
Department of Paediatric and Preventive Dentistry Division-7 Room number-7 Narayana Dental College and Hospital Chinthareddypalem Nellore Andhra pradesh Nellore ANDHRA PRADESH 524003 India
Nellore
ANDHRA PRADESH
524003
India 
Phone  9441624429  
Fax    
Email  dentist4kids@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K V Saikiran 
Designation  Assistant Professor 
Affiliation  Narayana Dental College and Hospital  
Address  Department of Paediatric and Preventive Dentistry Division-7 Room number-7 Narayana Dental College and Hospital Chinthareddypalem Nellore Andhra pradesh Nellore ANDHRA PRADESH 524003 India
Department of Paediatric and Preventive Dentistry Division-7 Room number-7 Narayana Dental College and Hospital Chinthareddypalem Nellore Andhra pradesh Nellore ANDHRA PRADESH 524003 India
Nellore
ANDHRA PRADESH
524003
India 
Phone  8125774535  
Fax    
Email  saikiran4u2008@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatric and Preventive Dentistry Division-7 Room number-7 Narayana Dental College and Hospital Chinthareddypalem Nellore Andhra pradesh  
 
Primary Sponsor  
Name  Dr Shaik Sameera 
Address  Narayana Dental College and Hospital Chinthareddypalem Nellore 5234003 Andhra Pradesh India 
Type of Sponsor  Other [Self sponsor] 
 
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 Shaik Sameera  Narayana Dental college and Hospital  Divivsion-7 Department of Paediatric and Preventive Dentistry Nellore Nellore ANDHRA PRADESH
Nellore
ANDHRA PRADESH 
8919116647

shaiksameera2407@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Narayana Dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional mouth mirror   It is an conventional mouth mirror which does not have any magnification  
Intervention  Magnification Loupes  Magnification loupes are specialized optical instruments used in various fields, including dentistry, surgery, and precision work, to enhance visual acuity and precision 
Intervention  Magnified Mouth Mirror  A magnified mouth mirror, an essential tool in dentistry, is designed to provide enhanced visualization and illumination of the oral cavity.  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children aged between 7-12 years of age
2.Caries involving occlusal surface of primary molars
3.Caries involving buccal and lingual surfaces of primary molars
 
 
ExclusionCriteria 
Details  1.Children less than 7 years of age
2.Caries involving proximal surface of primary molars
3.Caries involving pulp
4.Children with special health care needs
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Caries removal without any residual caries remained with help of different interventions 
 
Secondary Outcome  
Outcome  TimePoints 
comparison of which intervention is better helpful in removing caries  
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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/ Phase 4 
Date of First Enrollment (India)   24/06/2025 
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="3"
Days="0" 
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  

Over the past few decades, technological advances in endodontics have been quantum leaps from direct vision to magnification. Despite the growing body of evidence suggesting that the of magnification improves visual acuity, the dentist’s posture and the quality of dental procedures. In dentistry, loupes and operating microscopes have become part of the normal equipment of many dentists. They improve near visual acuity and help to compensate for visual deficiencies. The prime treatment objective for carious teeth requiring operative intervention is complete removal of infected dentin followed by placement of a well-sealed, long-lasting restoration. Tactile and visual criteria are normally used to render a cavity caries-free, and the idea of a diagnostic aid that would differentiate infected dentin was considered desirable.  Hence the present study intends to evaluate the magnified mouth mirror, magnification loupes in removal of carious dentin in class I cavity preparation.

 

Aim: This study aimed to assess the impact of magnified mouth mirror and magnification loupes on vision and quality of cavity preparation on primary molars.

Objective: To evaluate the quality of class 1 cavity preparation in children aged between 7 to 12 years using magnification loupes, magnified mouth mirror and conventional mouth mirror.

The randomized clinical trial was carried out in the Department of Paediatric and Preventive Dentistry,

Narayana Dental College and hospital, Nellore. The informed consent was obtained from the parents of the children who participated in the study.

A sample of 45 healthy children aged 7-12 years with 45 primary molar teeth showing dentinal caries requiring class I restoration will be selected and divided into three groups (15 in each group) using simple randomization. Group 1 : Caries removed using magnification loupes; Group 2: Caries removed using magnified mouth mirror; Group 3: Caries removes using conventional mouth mirror. X-ray will be taken to fulfil all inclusion criteria and to exclude caries in proximal surfaces. After caries excavation using a handpiece and hand instruments, The cavity preparation was considered as caries-free when a hard cavity floor was felt upon gentle pressure with a dental explorer that did not stick in the dentin. The dye was applied for 10 seconds and was rinsed off with sterile saline. The efficacy was graded from 0 to 5 by the co-investigator using the criteria proposed by Ericson et al. pictures of the tooth stained by residual caries will be taken using macro lens attached to android mobile phone. Finally, the data will be analyzed statistically to determine the variations between the three group. 



 
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