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

Alveolar Ridge Enlargement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376320
• Other study ID #: UAlexandriaDentSurg
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: October 4, 2020

Study information

• Verified date: November 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 4, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Ridge Enlargement
• Hypertrophy

Intervention

Device:
• customised ceramic sheets (Group 1)
guided bone regeneration

Combination Product:
• modified sausage technique (Group 2)
guided bone regeneration

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Lydia Nabil

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean percentage of change of alveolar bone height	change of alveolar bone height after surgery	6 months