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

Not Applicable

Completed

• Conditions: Alveolar Ridge Enlargement
• Interventions: Combination Product: modified sausage technique (Group 2); Device: customised ceramic sheets (Group 1)

• Registration Number: NCT04376320
• Lead Sponsor: Lydia Nabil

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).

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-06
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-04
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (modified sausage technique)	modified sausage technique (Group 2)	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 1(ceramic membrane)	customised ceramic sheets (Group 1)	using customized ceramic membranes for augmentation of vertical mandibular ridge defects in preparation for implant placement

Primary Outcome Measures

Name	Time	Method
mean percentage of change of alveolar bone height	6 months	change of alveolar bone height after surgery

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Alexandria, Egypt