Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472453
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-28
Brief Title:
Vallomix Socket Preservation Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Prospective Comparative Assessment of Alveolar Ridge Preservation Using Vallomix in Atraumatic Extraction Socket
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
This research aims to compare the effectiveness of two bone grafting materials on preserving jawbone integrity after tooth extraction Following extraction the jawbone surrounding the removed tooth can shrink affecting future implant placement By placing a bone graft material in the extraction socket we aim to maintain adequate jawbone space for future implants This study compares the effectiveness of vallomix xenogeneicallogeneic bone and vallos allogeneic bone grafting materials
Participants with at least one tooth planned for extraction and subsequent implant placement are sought for this study Participants will be randomly assigned to either the vallomix test group or the vallos control group
Throughout the approximately 2-year study duration participants will undergo oral exams x-rays surgical procedures and follow-up visits All participants will undergo routine tooth extraction bone graft material placement and dental implant placement After the crown is placed on the implant participants will attend follow-up visits
Participation in the study is voluntary and the alternative is to continue routine dental care Risks include minor discomfort from procedures such as tooth extraction and implant placement The major benefit of participation in the study is the preservation of jaw dimensions following extraction which will simplify the placement of a dental implant
Participants with at least one tooth planned for extraction and subsequent implant placement are sought for this study Participants will be randomly assigned to either the vallomix test group or the vallos control group
Throughout the approximately 2-year study duration participants will undergo oral exams x-rays surgical procedures and follow-up visits All participants will undergo routine tooth extraction bone graft material placement and dental implant placement After the crown is placed on the implant participants will attend follow-up visits
Participation in the study is voluntary and the alternative is to continue routine dental care Risks include minor discomfort from procedures such as tooth extraction and implant placement The major benefit of participation in the study is the preservation of jaw dimensions following extraction which will simplify the placement of a dental implant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None