| CTRI Number |
CTRI/2021/10/037665 [Registered on: 28/10/2021] Trial Registered Prospectively |
| Last Modified On: |
27/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Efficacy of caries removal on deciduous molars using Papain gel and Excavator tip. |
|
Scientific Title of Study
|
Comparing the pain response, effectiveness and duration of caries removal using a papain based gel and an ultrasonic excavator tip in deciduous molars: A split mouth randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arthi |
| Designation |
pediatric and preventive dentistry, post graduate |
| Affiliation |
SRM dental college |
| Address |
SRM dental college Bharathi salai ramapuram chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
09360305261 |
| Fax |
|
| Email |
arthi.mrt.11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Hemalatha |
| Designation |
Head of the department, pediatric and preventive dentistry |
| Affiliation |
|
| Address |
3rd floor, PG block II,SRM dental college Bharathi salai ramapuram chennai
3rd floor, PG block II,SRM dental college Bharathi salai ramapuram chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9884585808 |
| Fax |
|
| Email |
srmpedodpt16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Arthi |
| Designation |
Pediatric and preventive dentistry, post graduate student |
| Affiliation |
|
| Address |
3rd floor, PG block II,SRM dental college Bharathi salai ramapuram chennai
3rd floor, PG block II,SRM dental college Bharathi salai ramapuram chennai
Thiruvallur
TAMIL NADU
600089
India |
| Phone |
09360305261 |
| Fax |
|
| Email |
arthi.mrt.11@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.Arthi, PG student, SRM dental college and hospital, Bharathi salai, ramapuram, chennai-89 |
|
|
Primary Sponsor
|
| Name |
Dr M Arthi |
| Address |
No.3&4, AKM enclave, thiruvalluvar salai, rampuram, chennai |
| Type of Sponsor |
Other [self financed] |
|
|
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 |
| Arthi |
SRM dental college |
Department of pediatric and preventive dentistry, SRM dental college, bharathi salai, ramapuram, chennai
Chennai
TAMIL NADU |
09360305261
arthi.mrt.11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB)SRM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Brix 3000 |
it has effective and selective proteolytic action to remove collagen fibres in the carious tissue while preserving the affected demineralized dentin. duration of therapy is about 30 minutes for each group |
| Intervention |
ultrasonic excavator tip(EX1) |
The ultrasonic excavator is more comfortable for dentist and children than manual excavator because the ultrasonic wave can easily penetrate to caries and defective dentine, furthermore, it will cause less trauma, heat generation and laceration, and it can remove a deep carious teeth more biologically and conservatively.
The duration of the therapy for both the group is about 30 minutes. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of two contralateral open carious lesion with dentin involvement
2. Cavities are assessible to facilitate the penetration of a small size excavator.
3. Teeth and surrounding tissues should be clinically free of any pathologic conditions other than dental caries
4. Presence of asymptomatic carious molars without clinical evidence of pulp involvement
5. Class I carious lesion
|
|
| ExclusionCriteria |
| Details |
1. non vital teeth
2. arrested caries
3. Children with systemic diseases
4. Grossly decayed
5. Caries in primary teeth exhibiting pre shedding mobility.
11. periodontal problem |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of the study is to assess the effectiveness of caries removal using Ericson criteria
|
within 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The secondary outcomes of the study is to assess the pain response of children using Wong Bakers scale and FLACC.
2.To assess the total working time required for caries removal using Brix 3000 and ultrasonic excavator recorded in minutes using a stopwatch
3.To assess the retention, marginal discoloration, secondary caries, marginal adaptation of restoration at 3, 6 months using USPHS criteria
|
1.within 1 hour
2.within 30 minutes
3.3,6 months interval |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
04/11/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to evaluate the efficacy of caries removal, amount of time taken and the pain experienced by the children aged 4 to 7 years using brix 3000 and ultrasonic excavator in primary molars. It is a randomized controlled trial with split mouth design. The sample size is estimated to be 62 with 1:1 allocation ratio, simple random sampling. The methodology includes caries removal checked using an explorer. The time taken for complete caries removal was recorded and compared using a stopwatch. The pain threshold of caries removal measured by wong bakers Scale and flacc, assessing the retention, marginal discoloration, secondary caries, marginal adaptation of restoration at 3, 6 months using USPHS criteria. The obtained data will be subjected to statistical analysis. |