Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT03786302
Status:
TERMINATED
Last Update Posted:
2020-10-14
First Post:
2018-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regenerative Ability of TAMP BG and BD in Pulpotomized Primary Teeth
Sponsor:
Nourhan M.Aly
Organization:
Study Overview
Official Title:
Comparison of the Regenerative Ability of Tailored Amorphous Multiporous Bioglass and Biodentine in Pulpotomized Primary Teeth
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure rate was 100% in one arm of the study (the intervention)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to assess clinically, radiographically, and histologically the regenerative ability of Tailored Amorphous Mulioporous (TAMP-BG) bioglass in comparison to Biodentine™ (BD) in pulpotomized primary teeth.
Detailed Description:
The study was a parallel design, randomized controlled clinical trial It was conducted in the out-patient clinic of the Pediatric Dentistry and Dental public health department after obtaining the guardians consent. The sample size was calculated to be 35 teeth per group. The teeth were randomly and equally assigned to either BD or TAMP-BG groups.The treatment follow-up was scheduled at 1, 3, 6, 9 and 12 months. The study was terminated for ethical considerations after showing significant clinical failure in the TAMP-BG group and after performing interim analysis.
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?: