Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 1:00 PM
Study NCT ID:
NCT06620367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided Sausage Technique in Bone Regeneration As a Novel Digital Work Flow
Sponsor:
Tanta University
Organization:
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:
False
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 2,7,14 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 2,7,14 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 (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane without use of guide \& 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:
True
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?:
False
Is an FDA AA801 Violation?: