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

NCT ID: NCT04376320

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-10-04

Brief Summary

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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

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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).

Conditions

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Alveolar Ridge Enlargement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1(ceramic membrane)

using customized ceramic membranes for augmentation of vertical mandibular ridge defects in preparation for implant placement

Group Type ACTIVE_COMPARATOR

customised ceramic sheets (Group 1)

Intervention Type DEVICE

guided bone regeneration

Group 2 (modified sausage technique)

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

Group Type ACTIVE_COMPARATOR

modified sausage technique (Group 2)

Intervention Type COMBINATION_PRODUCT

guided bone regeneration

Interventions

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customised ceramic sheets (Group 1)

guided bone regeneration

Intervention Type DEVICE

modified sausage technique (Group 2)

guided bone regeneration

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lydia Nabil

OTHER

Sponsor Role lead

Responsible Party

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Lydia Nabil

Assistant Professor of Oral and Maxillofacial Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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UAlexandriaDentSurg

Identifier Type: -

Identifier Source: org_study_id