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

Not Applicable

Active, not recruiting

• Conditions: Digital Guided Bone Regeneration
• Interventions: Procedure: conventional guided bone regeneration; Procedure: digital guided bone regeneration

• Registration Number: NCT06620367
• Lead Sponsor: Tanta University

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

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 Timeline

• Study Start: 2024-04-20
• Status Verified: 2024-09
• Primary Completion: 2024-09-24
• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Study Completion: 2024-10-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• medium horizontal ridge defect according to clone classification
• must have a general health showing no contraindications for surgery
• must be at least 35 years old
• patients also have adequate soft tissue thickness and width of keratinized gingiva

Exclusion Criteria

• no sign of uncontrolled systemic diseases
• non smoker
• not pregnant
• sever ridge deficient
• patients below 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional guided bone regeneration	conventional guided bone regeneration	a medium horizontal ridge defect will receive bone graft and covered with membrane
digital guided bone regeneration	digital guided bone regeneration	digital designed guide will be used in a medium horizontal ridge defect to place bone graft and covered with membrane

Primary Outcome Measures

Name	Time	Method
flap dehiscence	14 days	the flap dehiscence will be assessed using a UNC periodontal probe through the the wound opening of buccolingual distance between sutured flap margins

Secondary Outcome Measures

Name	Time	Method
bone gain	6 months	bone gain will be assessed using cone beam computed tomography (CBCT)
bone denisty	6 months	cone beam computed tomography (CBCT) will be used to asses bone density

Trial Locations

Locations (1)

faculty of dentistry Tanta university; 🇪🇬 Tanta, Egypt