NCT05813340

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

April 2, 2023

Last Update Submit

April 2, 2023

Conditions

Keywords

VIPCTFGBRHorizontal ridge augmentation

Outcome Measures

Primary Outcomes (1)

  • Amount of bone width gain (horizontal augmentation)

    bone width gain is measured in millimeters by Cone beam computed tomography

    6 months

Secondary Outcomes (1)

  • Percentage of bone formation in the bone biopsy

    6 months

Study Arms (2)

vascularized interpositional periosteal connective tissue flap

EXPERIMENTAL

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

collagen membrane

ACTIVE COMPARATOR

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

Interventions

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

collagen membranevascularized interpositional periosteal connective tissue flap

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry Cairo university

Cairo, 12311, Egypt

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

Study Officials

  • Esraa Ismail, Maters

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esraa Ismail, Masters

CONTACT

Rofaida Atef, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

April 2, 2023

First Posted

April 14, 2023

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations