RecruitingNot ApplicableNCT05584566

Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®

Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® Membrane in Simultaneous Implantations. A Prospective, Randomized Controlled Trial.


Sponsor

Datum Dental LTD

Enrollment

65 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective randomized controlled parallel trial. The aim of this study is to evaluate bone formation and soft tissue healing after 4 and 8 months in patients with ridge deficiencies in simultaneous implantation approach. The trial will compare a (sugar cross linked) - SCL pericardium membrane OSSIX® Breeze vs native pericardium membrane (Jason®).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

When a tooth is missing or extracted, the surrounding jawbone can shrink. Before placing a dental implant, some patients need bone rebuilding (guided bone regeneration). This study compares two collagen membranes — OSSIX BREEZE and Jason — used in that procedure to see which leads to better bone growth and implant outcomes. You may be eligible if: - You are 18 or older and in generally good health - You have a jawbone defect and need 1–3 dental implants - You need a guided bone regeneration procedure - You have good oral hygiene You may NOT be eligible if: - You have an autoimmune disease, connective tissue disease, or oral inflammatory condition - You are allergic to collagen or pork-derived products - You are currently pregnant or breastfeeding - You smoke more than 10 cigarettes a day - You have had radiation therapy to the head - You are on immunosuppressants, bisphosphonates, or high-dose steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOSSIX Breeze

barrier membrane

DEVICEJason membrane

barrier membrane


Locations(3)

Hadassah Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

University of Birmingham

Birmingham, United Kingdom

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NCT05584566


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