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

Innovative Approach in Guided Bone Regeneration Using Digitally Designed Surgical Guide

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

Study Overview

• Status: Active, not recruiting
• Conditions: Digital Guided Bone Regeneration
• Intervention / Treatment: Procedure: conventional guided bone regeneration; Procedure: digital guided bone regeneration

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • faculty of dentistry Tanta university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional guided bone regeneration; a medium horizontal ridge defect will receive bone graft and covered with membrane	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
Active Comparator: digital guided bone regeneration; digital designed guide will be used in a medium horizontal ridge defect to place bone graft and covered with membrane	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
flap dehiscence	the flap dehiscence will be assessed using a UNC periodontal probe through the the wound opening of buccolingual distance between sutured flap margins	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone gain	bone gain will be assessed using cone beam computed tomography (CBCT)	6 months
bone denisty	cone beam computed tomography (CBCT) will be used to asses bone density	6 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Bassem nabil elfahl, assistant professor, faculty of dentistry Tanta university

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2024
• Primary Completion (Estimated): September 24, 2024
• Study Completion (Estimated): October 20, 2024

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: #R-OMPDR- 6-24-3122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No