NCT06620367

Guided Sausage Technique in Bone Regeneration As a Novel Digital Work Flow

Innovative Approach in Guided Bone Regeneration Using Digitally Designed Surgical Guide

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Digital Guided Bone Regeneration

Interventions

Type	Name	Description
PROCEDURE	conventional guided bone regeneration	10 sites with medium horizontal ridge defect will be treated with bone graft (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane stabilized by tacks
PROCEDURE	digital guided bone regeneration	10 sites with medium horizontal ridge defect will be treated with bone graft (50%autogenous mixed with 50%xenograft) placed by digital designed guide covered with bilayer collagen membrane stabilized by tacks

Timeline

• Start date: 2024-04-20
• Primary completion: 2024-09-24
• Completion: 2024-10-20
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: Egypt