Ignite Creation Date:
2024-05-06 @ 12:19 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03731975
Status:
UNKNOWN
Last Update Posted:
2018-12-24
First Post:
2018-10-25
Brief Title:
Endodontic Treatment Using CTZ Paste in Primary Teeth
Sponsor:
Faculty Sao Leopoldo Mandic Campinas
Organization:
Faculty Sao Leopoldo Mandic Campinas
Study Overview
Official Title:
Efficacy of Endodontic Treatment Using CTZ Paste in Primary Teeth Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLM2204
Brief Summary:
The aim of this study is to evaluate the efficacy of CTZ Paste in primary teeth compared to endodontic treatment with Guedes-Pinto Paste This is a multicenter randomized double-blind patient controlled and non-inferiority clinical study on 174 primary molars and 174 primary incisors of 3-6 years-old children with carious lesions with pulp involvement The sample unit will be the tooth which will be randomized into two groups The teeth allocated to the experimental group will be treated with CTZ Paste whereas the treatment of those teeth allocated to the control group will employ the Guedes-Pinto Paste The procedures performed will be evaluated clinically and radiographically at 6 and 12 months Secondary outcomes such as cost discomfort satisfaction and quality of life will also be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None