| 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
|
|
|
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
|
|
|
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 |
1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of which intervention is better helpful in removing caries |
1 |
|
|
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.
|