| CTRI Number |
CTRI/2024/10/075134 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of magnification on caries removal and quality of filling during tooth filling procedure among age 6-12 year old children |
|
Scientific Title of Study
|
The effect of dental loupes on caries excavation and quality of restoration during restorative procedure among 6-12 year old children - 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 |
MArumathi |
| Designation |
Undergraduate |
| Affiliation |
tagore dental college and hospital |
| Address |
department of pediatric and preventive dentistry, 1st floor, room number 6, Tagore dental college and hospital,rathinamangalam.
Chennai
TAMIL NADU
600127
India |
| Phone |
8838277570 |
| Fax |
|
| Email |
arumathimurugan6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavithra |
| Designation |
Senior lecturer |
| Affiliation |
Tagore dental college and hospital |
| Address |
department of pediatric and preventive dentistry, 1st floor, room number 6, Tagore dental college and hospital,rathinamangalam.
Chennai
TAMIL NADU
600127
India |
| Phone |
7871185094 |
| Fax |
|
| Email |
pavi.singh2627@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPavithra |
| Designation |
Senior lecturer |
| Affiliation |
Tagore dental college and hospital |
| Address |
department of pediatric and preventive dentistry, 1st floor, room number 6, Tagore dental college and hospital,rathinamangalam.
Chennai
TAMIL NADU
600127
India |
| Phone |
7871185094 |
| Fax |
|
| Email |
pavi.singh2627@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, 1st floor, Room number 6, Tagore Dental College and Hospital, Rathinamangalam. |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Department of Pediatric and Preventive Dentistry, 1st floor, Room number 6, Tagore Dental College and Hospital, Rathinamangalam. |
| Type of Sponsor |
Other [self ] |
|
|
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 Pavithra |
Tagore dental college and hospital |
department of pediatric and preventive dentistry, 1st floor, room number 6, Tagore dental college and hospital,rathinamangalam.
Chennai
TAMIL NADU |
7871185094
pavi.singh2627@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitiee tagore dental 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 |
| Intervention |
dental loupes |
Rotary and Hand caries excavation with dental loupes followed by restoration of the tooth.
Frequency is once
Total duration is 30 minutes |
| Comparator Agent |
without dental loupes |
Rotary and Hand caries excavation without dental loupes followed by restoration of the tooth.
Frequency is once
Total duration is 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
a. Children of 6-12 years of age
b. Children with class 1 dental caries in primary and permanent 1st molar
c. No history of pain, swelling.
|
|
| ExclusionCriteria |
| Details |
a. Patient with no consent
b. Medically compromised children.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| quality of restoration and caries excavation |
baseline, 1day, 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
20/10/2024 |
| 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="4"
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
|
Background: The principles of minimally invasive
dentistry have gained prominence, emphasizing the importance of magnification
tools such as dental loupes in enhancing treatment quality and precision.
However, limited research exists on their efficacy in pediatric dentistry.
Objective: This study aims to evaluate the
effects of dental loupes on caries excavation efficiency and the quality of
restorations in children aged 6 to 12 years.
Methods: A randomized, split-mouth design will
be employed, involving 30 children with class 1 dental caries in primary and
permanent first molars. Participants will be divided into two groups: Group A
will receive rotary and hand caries excavation with dental loupes, while Group
B will undergo the same procedures without loupes. Caries removal will be
assessed using visual-tactile criteria by Bjorndal et al., and the quality of
restorations will be evaluated using modified USPHS criteria. Statistical analysis
will include frequency percentages and chi-square tests to compare outcomes
between the two groups.
Results: The study anticipates that the use of
dental loupes will significantly improve caries removal efficiency and
restoration quality compared to procedures performed without loupes.
Conclusion: This research aims to provide
valuable insights into the role of dental loupes in pediatric restorative
dentistry, potentially influencing clinical practices and promoting the
adoption of magnification tools to enhance treatment outcomes for young patients. |