Vascularized Inter-positional Periosteal Connective-tissue Flap Versus Collagen Membrane in Guided Bone Regeneration (VIP-CT)

Vascularized Inter-positional Periosteal Connective-tissue Flap Versus Collagen Membrane in Guided Bone Regeneration in Horizontal Ridge Augmentation in Aesthetic Zone

this study compares 2 techniques in guided bone regeneration for horizontal ridge augmentation in aesthetic zone

Study Overview

• Status: Recruiting
• Conditions: Horizontal Ridge Deficiency
• Intervention / Treatment: Procedure: Vascularized inter-positional periosteal connective tissue flap

Detailed Description

Guided bone regeneration is a technique for ridge augmentation using membranes The membrane of GBR is an essential component of treatment as it has some important characteristics manageability, space-making ability, and adequate mechanical, physical properties, and biocompatibility Collagen membranes are the most commonly used and can inhibit soft tissue growth in bone defects and achieve better wound healing and bone regeneration.

on the other hand, a Vascularized inter-positional periosteal connective tissue flap is a flap that has been used as a substitute for the collagen membrane with promising results. Vascularized inter-positional periosteal connective tissue flap (VIPCTF) may have many advantages over traditional collagen membranes such as; high vascularity, decreased cost (as it may substitute membrane), providing an increase in soft tissue thickness, and reusability.

So Evaluation of effect of vascularized interpositional periosteal connective tissue flap on horizontal ridge augmentation grafting of the anterior maxilla in comaprison with the collagen membranes

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esraa Ismail, Masters; Phone Number: +2 01155400246; Email: esera.hady@dentistry.cu.edu.eg
• Study Contact Backup: Name: Rofaida Atef, PhD; Phone Number: +2 01289980034

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Recruiting
    • Faculty of Dentistry Cairo University
    • Contact: Faculty of Dentistry; Phone Number: 0223646375

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with a horizontal defect in anterior and premolar areas of the maxilla (aesthetic zone).

Exclusion Criteria:

• poor oral hygiene
• radiation therapy of head and neck cancer
• intraoral soft and hard tissue lesions
• Heavy smoking
• Bone pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vascularized interpositional periosteal connective tissue flap; Vascularized inter-positional periosteal connective tissue flap (VIPCTF) may have many advantages over traditional collagen membranes such as; high vascularity, decreased cost (as it may substitute membrane), providing an increase in soft tissue thickness, and reusability.	Procedure: Vascularized inter-positional periosteal connective tissue flap; It is a vascularized pedicled flap derived from the hard palate that can be used as a barrier to prevent in growth of soft tissue in guided bone regeneration and to increase soft tissue quantity
Active Comparator: collagen membrane; Collagen membranes are the most commonly used and can inhibit soft tissue growth in bone defects, They achieve better wound healing and bone regeneration.	Procedure: Vascularized inter-positional periosteal connective tissue flap; It is a vascularized pedicled flap derived from the hard palate that can be used as a barrier to prevent in growth of soft tissue in guided bone regeneration and to increase soft tissue quantity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of bone width gain (horizontal augmentation)	bone width gain is measured in millimeters by Cone beam computed tomography	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of bone formation in the bone biopsy	Area percentage of newly formed bone is measured through histomorphometric analysis	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Esraa Ismail, Maters, Cairo university

Publications and helpful links

General Publications

• Khajehahmadi, S., & Rahpeyma, A. (2014). Vascularized interpositional periosteal connective tissue flap in implant dentistry. Journal of Dental Implants, 4(1), 29. https://doi.org/10.4103/0974-6781.130952

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: GBR; VIPCTF; Horizontal ridge augmentation
• Other Study ID Numbers: 111111 (Other Grant/Funding Number: FUZEhub)

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