Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-15 @ 8:42 AM
Study NCT ID:
NCT02881905
Status:
UNKNOWN
Last Update Posted:
2016-09-12
First Post:
2016-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PeriImplant Soft Tissue and Marginal Bone Loss of Single Implant Mandibular Overdenture
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Peri-Implant Soft Tissue Health and Marginal Bone Loss of Single Implant Mandibular Overdenture Retained by CM LOC Versus Ball Attachment: A Randomised Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2016-09
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:
None
Brief Summary:
There is a significant difference between CM LOC and ball attachment, when considering the peri-implant soft tissue health and marginal bone loss. The primary and secondary objectives are to determine if CM LOC attachment improves the peri-implant soft tissue response and decreases the marginal bone loss around implant when compared to conventional ball attachment
Detailed Description:
Ball attachments are very commonly used because they are solitary, simple, easier to use and less technique sensitive if compared to bar attachments. However, ball attachment require a prosthetic space of 12 mm and could show tremendous wear if implants were mal-aligned. CM LOC attachment is newly introduced into market with very good expectations regarding its properties and effect on the periimplant soft tissue. CM LOC attachment, which combes titanium patrix and resin matrix made from polyetherketoneketone (PEKK), is a very promising material regarding the wear and the prosthesis retention it provides, even with mal-aligned implants. However, the clinical performance of this attachment was not tested yet. Therefore, in this randomized controlled trial it was decided to compare between CM LOC and the commonly used ball attachment regarding the soft tissue health and marginal bone loss.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: