Back to results

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

Primary Purpose

Alveolar Ridge Enlargement

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

customised ceramic sheets (Group 1)

modified sausage technique (Group 2)

About this trial

This is an interventional treatment trial for Alveolar Ridge Enlargement

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 1(ceramic membrane)

Group 2 (modified sausage technique)

Arm Description

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

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

Outcomes

Primary Outcome Measures

mean percentage of change of alveolar bone height

change of alveolar bone height after surgery

Secondary Outcome Measures

Full Information

NCT ID

NCT04376320

First Posted

April 29, 2020

Last Updated

November 2, 2020

Sponsor

Lydia Nabil

1. Study Identification

Unique Protocol Identification Number

NCT04376320

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

September 30, 2020 (Actual)

Study Completion Date

October 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lydia Nabil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alveolar Ridge Enlargement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1(ceramic membrane)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 2 (modified sausage technique)

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

customised ceramic sheets (Group 1)

Intervention Description

guided bone regeneration

Intervention Type

Combination Product

Intervention Name(s)

modified sausage technique (Group 2)

Intervention Description

guided bone regeneration

Primary Outcome Measure Information:

Title

mean percentage of change of alveolar bone height

Description

change of alveolar bone height after surgery

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Faculty of Dentistry

City

Alexandria

ZIP/Postal Code

21411

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs