Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Guided Sausage Technique in Bone Regeneration As a Novel Digital Work Flow
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Innovative Approach in Guided Bone Regeneration Using Digitally Designed Surgical Guide
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCT
Brief Summary:
The goal of this clinical trial is to compare amount of bone resorption and flap dehiscence following guided bone regeneration with or without digitally designed surgical guide The main questions it aims to answer are
Does it differ in amount of bone resorption between the conventional and digital guided bone regeneration
What is the difference between conventional and digital protocols regarding flap dehiscence following guided bone regeneration Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use
Participants will
Receive guided bone regeneration around implant
Visit the clinic after 2714 days for detection any signs of flap dehiscence
Bone gain and bone density will be assessed after 6 months
Does it differ in amount of bone resorption between the conventional and digital guided bone regeneration
What is the difference between conventional and digital protocols regarding flap dehiscence following guided bone regeneration Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use
Participants will
Receive guided bone regeneration around implant
Visit the clinic after 2714 days for detection any signs of flap dehiscence
Bone gain and bone density will be assessed after 6 months
Detailed Description:
Twenty sites with ridge defects will be recruited for this study All investigations will be carried out in accordance with the 1975 Helsinki Declaration as revised in 2013 for clinical approval The purpose of the present study will be explained to the patients and informed consents will be obtained Sites were randomly divided into 2 treatment groups 10 sites will be treated with bone graft 50autogenous mixed with 50xenograft covered with bilayer collagen membrane without use of guide amp 10 sites will receive the same treatment except it will be guided using digitally designed guide Membranes in both groups will be stabilized by tacks Following clinical parameters will be recorded the wound opening of buccolingual distance between sutured flap margins with a UNC periodontal probe to the nearest millimeter at 2 7 and 14 days flap dehiscence Also bone gain and bone density will be assessed using cone beam computed tomography CBCT at baseline and 6 months post-surgery The collected data was statistically analyzed at the different follow up periods
Study Oversight
Has Oversight DMC:
None
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?:
None