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

L

Lydia Nabil

Status

Completed

Conditions

Alveolar Ridge Enlargement

Treatments

Combination Product: modified sausage technique (Group 2)
Device: customised ceramic sheets (Group 1)

Study type

Interventional

Funder types

Other

Identifiers

NCT04376320
UAlexandriaDentSurg

Details and patient eligibility

About

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).

Full 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).

Enrollment

14 patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

14 participants in 2 patient groups

Group 1(ceramic membrane)
Active Comparator group
Description:
using customized ceramic membranes for augmentation of vertical mandibular ridge defects in preparation for implant placement
Treatment:
Device: customised ceramic sheets (Group 1)
Group 2 (modified sausage technique)
Active Comparator group
Description:
using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique) for augmentation of vertical mandibular ridge defects in preparation for implant placement
Treatment:
Combination Product: modified sausage technique (Group 2)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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