Ridge augmentation treatment using OSSIX® BREEZE vs Jason® membrane
Research type
Research Study
Full title
Ridge augmentation treatment using OSSIX® BREEZE vs Jason® membrane in simultaneous implantations. A prospective, randomized controlled trial.
IRAS ID
335787
Contact name
Helena Gryner
Contact email
Sponsor organisation
Datum Dental LTD
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The purpose of this study is to evaluate bone formation and soft tissue healing after 4 and 8 months in patients who have defects in the alveolar ridge (part of their jaw) and need bone regeneration at the same time as receiving an implant (one-step procedure). The trial will compare two different membranes, the study product, OSSIX® Breeze (a pig pericardial derived membrane that has been cross linked with a sugar) with a different commercial pig pericardial membrane marketed by botiss biomaterials GmbH - Jason® membrane. Alveolar ridge augmentation, bone regeneration or grafting requires cells from the relevant tissues (bone) to fill the defect and to regain the height, width, and quality of the bone. A barrier membrane is positioned between the bone and any other tissues (soft tissue or gum) that might interfere with the process. This membrane keeps the tissues separate until the newly formed bone tissue matures and populates the targeted area. Without the protective membrane, soft tissues would populate the defect area more rapidly than bone tissue cells, making the ridge less suitable for placement of future implants or prosthetics.
The study aims to look at the increase in bone in the implant area after 4 months of having the dental implant.
In addition to looking at the safety of OSSIX® Breeze, the condition of the gums and tissue after 4 months and the amount of bone, gum and tissues after 8 months. We will also be looking at the overall stability of the implant and patient satisfaction with the implant.
During the eight months that participants are in the study they will make a total of 7 visits to the clinic: screening visit, baseline/surgical implantation visit, 3 follow-up visits, surgery to expose the implant, install the crown and a final visit at 8 months.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0080
Date of REC Opinion
24 May 2024
REC opinion
Further Information Favourable Opinion