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Clinical Trials/NCT04376320
NCT04376320
Completed
Not Applicable

Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects

Lydia Nabil1 site in 1 country14 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar Ridge Enlargement
Sponsor
Lydia Nabil
Enrollment
14
Locations
1
Primary Endpoint
mean percentage of change of alveolar bone height
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of this study is to compare two pre-prosthetic surgical techniques for augmentation of vertical mandibular ridge defects in preparation for implant placement, the first using customized ceramic membranes and the second using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique).

Detailed Description

Background: Expansion of the periosteum and soft tissue matrix by tenting has been described as a method of Guided Bone Regeneration (GBR) for reconstruction of atrophic alveolar ridges. Materials and Methods: The current study is a prospective controlled clinical trial, conducted on 14 patients, having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal. They are divided into 2 equal groups, each consisting of 7 patients. The first group receives customized ceramic membranes with a vertical height 5 mm above the crest of the ridge to tent out the soft tissue matrix, while in the second group, tenting of the soft tissue is done by fixation of two tenting screws, particulate bone graft is packed then covered by collagen membrane that is fixed by bone tacks (modified sausage technique).

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
October 4, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lydia Nabil
Responsible Party
Sponsor Investigator
Principal Investigator

Lydia Nabil

Assistant Professor of Oral and Maxillofacial Surgery

University of Alexandria

Eligibility Criteria

Inclusion Criteria

  • patients of both genders
  • with age range from 40 to 60 years,
  • having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal and
  • requiring prosthetic rehabilitation with dental implants.

Exclusion Criteria

  • heavy smokers,
  • patients undergoing radiotherapy or chemotherapy,
  • those having infection or local lesions in the area of surgery, and
  • patients with bone diseases which may compromise the results

Outcomes

Primary Outcomes

mean percentage of change of alveolar bone height

Time Frame: 6 months

change of alveolar bone height after surgery

Study Sites (1)

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