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Clinical Trials/NCT06620367
NCT06620367
Active, not recruiting
Not Applicable

Innovative Approach in Guided Bone Regeneration Using Digitally Designed Surgical Guide

Tanta University1 site in 1 country20 target enrollmentApril 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Digital Guided Bone Regeneration
Sponsor
Tanta University
Enrollment
20
Locations
1
Primary Endpoint
flap dehiscence
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2024
End Date
October 20, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mona Al-Ahmady El-Meligy

lecturer of periodontology

Tanta University

Eligibility Criteria

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

Outcomes

Primary Outcomes

flap dehiscence

Time Frame: 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 Outcomes

  • bone gain(6 months)
  • bone denisty(6 months)

Study Sites (1)

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