| CTRI Number |
CTRI/2024/06/069666 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Reducing the pain during caries removal by using ceramic and tungsten carbide burs in children |
|
Scientific Title of Study
|
Comparative Evaluation Of Efficacy And Pain Perception Of Children During The Removal Of Carious Dentin Using Ceramic And Tungsten Carbide Burs: 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 |
P Sravya |
| 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
524003
India
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9618905543 |
| Fax |
|
| Email |
sravyapuvvada34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S V S G Nirmala |
| Designation |
Assistant Professor |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of Paediatric and Preventive dentistry
Division-7
Roomnumber-7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
ANDHRA PRADESH
524003
India
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9440206976 |
| Fax |
|
| Email |
nimskrishna2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S V S G Nirmala |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and Preventive dentistry
Division-7
Roomnumber-7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
ANDHRA PRADESH
524003
India
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9440206976 |
| Fax |
|
| Email |
nimskrishna2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsor
Department of pediatric and preventive dentistry Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra Pradesh
India
524003
|
|
|
Primary Sponsor
|
| Name |
Dr P Sravya |
| Address |
Narayana dental college and hospital
Chinthareddypalem
Nellore
Andhra Pradesh
India
524003
|
| 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 P Sravya |
Narayana dental college and hospital |
Division-7 Department
of Pediatric and
preventive dentistry
Nellore
ANDHRA PRADESH
Nellore
ANDHRA PRADESH |
9618905543
sravyapuvvada34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Narayana Dental collge and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ceramic bur |
Ceramic bur has hardness less than that of healthy dentin. It is self limiting as it is designed to lose its cutting efficiency while in the sound dentin. Ceramic burs aim on selective removal of carious infected dentin consequently avoiding pain, so they could be more appropriate for young children. Ceramic bur will be used during removal of carious dentin. |
| Comparator Agent |
Tungsten carbide bur |
Tungsten carbide burs are stiffer than steel burs. They are hard enough to maintain sharpness and highly effective for cutting. They cut and chip away the tooth structure rather than grinding as diamond burs, this leaves a much smoother finish. Tungsten carbide bur will be used during removal of carious dentin. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children of age 4-8 years attending the dental hospital
Children with bilateral class I carious lesions on maxillary or mandibular either 1st or 2nd primary molars.
Teeth should be clinically free from any pathologic conditions other than dental caries.
Asymptomatic carious lesions with distinct dentin involvement verified by radiograph.
|
|
| ExclusionCriteria |
| Details |
Teeth showing clinical or radiographic signs of irreversible pulpitis and its sequelae.
Teeth with pathological conditions such as dental erosions or tooth developmental disorders
carious lesions extending proximally excluded by the x-ray
Children with systemic disorders
|
|
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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 |
| The primary outcome of the study is to determine the pain perception of children by using ceramic bur and tungsten carbide bur during the removal of carious dentin |
During caries excavation
After caries excavation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study is to determine the effectiveness of ceramic bur and tungsten carbide bur in removing carious dentin |
After caries excavation |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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="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
|
Dentin caries can be divided into two layers. The superficial or outer layer (infected dentin) is contaminated with bacteria, which dissolves the mineralized tissue of dentin and damages the collagen matrix so that remineralization becomes impossible. The pervasive conception of “Minimal Invasive Dentistry†implies that irreversibly denatured infected carious dentin should be removed selectively and preserved as much as possible potentially sound mineralizable tooth structure.
Aim: To evaluate the effectiveness of ceramic and tungsten carbide burs in removal of carious dentin and pain perception in children aged 4-8 years
Objectives:
· To assess the effectiveness of a ceramic bur in the removal of carious dentin and pain perception in children. · To assess the effectiveness of a tungsten carbide bur in the removal of carious dentin and pain perception in children. · To compare the effectiveness of a ceramic bur and tungsten carbide bur in the removal of carious dentin and pain perception in children
Methodology:
The present study will be a randomized clinical trial using simple randomization. A sample of 20 healthy children aged 4-8 years with 40 primary molar teeth (bilateral) showing dentinal caries requiring Class I restoration will be selected and divided into two groups (20 in each group) using simple randomization. Group1: Caries removed using Ceramic bur on low-speed handpiece, group2: Caries removed using Tungsten carbide bur on low-speed hand piece. X-ray will be taken to fulfil all inclusion criteria and to exclude caries in proximal surfaces. The caries excavation will be terminated after hard dentin is detected. In both the groups, during the procedure by FLACC scale and after completion of procedure Wong baker faces pain rating scale will be recorded. The efficacy of caries removal will be checked using an explorer after caries excavation so it should not stick to dentin, and not giving a tug-back sensation.
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