| CTRI Number |
CTRI/2020/09/027729 [Registered on: 10/09/2020] Trial Registered Prospectively |
| Last Modified On: |
03/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing the microbial colonies on two different caps given on childs teeth(molars). |
|
Scientific Title of Study
|
Evaluation of streptococcus mutans colonization and oral hygiene status in primary molars restored with two different crowns-A randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
J A Amilia Elizabeth |
| Designation |
PG student |
| Affiliation |
SRM dental college, Ramapuram |
| Address |
SRM Dental College and Hospital,
Bharathi Salai,
Ramapuram,
Chennai-600089
PG Block II, 3rd floor,
Department of pediatric and preventive dentistry,
Bharathi salai,
Ramapuram,
Chennai - 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9566125909 |
| Fax |
|
| Email |
amilia2810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRHemalatha |
| Designation |
Head of the Department |
| Affiliation |
SRM dental college, Ramapuram |
| Address |
SRM Dental College and Hospital,
Bharathi Salai,
Ramapuram,
Chennai-600089
PG Block II, 3rd floor,
Department of pediatric and preventive dentistry,
Bharathi salai,
Ramapuram,
Chennai - 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9840188571 |
| Fax |
|
| Email |
srmpedodpt16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
J A Amilia Elizabeth |
| Designation |
PG student |
| Affiliation |
SRM dental college, Ramapuram |
| Address |
SRM Dental College and Hospital,
Bharathi Salai,
Ramapuram,
Chennai-600089
PG Block II, 3rd floor,
Department of pediatric and preventive dentistry,
Bharathi salai,
Ramapuram,
Chennai - 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9566125909 |
| Fax |
|
| Email |
amilia2810@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.A.Amilia Elizabeth
PG student
SRM Dental college and hospital,
Bharathi Salai,
Ramapuram,
Chennai-600089 |
|
|
Primary Sponsor
|
| Name |
DrJAAmilia Elizabeth |
| Address |
No;3,1ST Street,Nandavana Mettur,Kamaraj Nagar,Avadi,Chennai-71 |
| 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 |
| JAAmilia Elizabeth |
srm dental college |
Department of Pedodontics and preventive dentistry,
Srm dental college,
bharathi salai,
ramapuram
Chennai
TAMIL NADU |
9566125909
amilia2810@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: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
stainless steel crowns |
they offer superior durability and biocompatibility. they are standard crowns used in dentistry from a long time |
| Intervention |
zirconia |
zirconia crowns are esthetic and it is good choice for dental material as it is chemically unreactive made of zirconium dioxide |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 4 to 07 yrs
2.Presence of atleast two carious primary molars indicated for pulp therapy on either side. (split mouth technique).
3.No history of antibiotic intake for past two weeks.
4.No history of fluoride application for past two weeks.
|
|
| ExclusionCriteria |
| Details |
1.Special children with physical or emotional alteration.
2.Children with systemic diseases .
3.Grossly decayed, unrestorable teeth, with maximum space loss.
4.Caries in primary teeth exhibiting pre shedding mobility.
|
|
|
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 |
| 1.To assess and compare the amount of streptococcus mutans colonization on SSC and zirconia crowns at 1month. |
1month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the gingival health and radiographic assessment following SSC and zirconia crown placement at 1month,3month,6month and 12 month follow up. |
1 month,3 month,6 month,12 month |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 1 |
|
Date of First Enrollment (India)
|
20/09/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/09/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 aimed to evaluate the adhesion of streptococcus mutans count on two different crowns- stainless steel crowns and zirconia on primary molars. It is a randomized control trial with split mouth design. The sample size is estimated to be 32 with 1:1 allocation ratio, simple random sampling. The methodology includes the collection of baseline swabs from the buccal mucosa of the tooth to be restored with the crown at the beginning of the study. The post operative swabs will be collected from both the crowns at one month interval. streptococcus mutans will be cultured in the selective medium of mitus salivarius bacitracin agar for its growth. the colony forming units will be counted using colony forming counter. the plaque, ginigival and oral hygiene indices will be recorded at 1month, 3 month, 9 month and 12 month interval. the data obtained will be subjected to statistical analysis. |