Guided Bone Regeneration With Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- The rate of healing complications after reconstructive surgery
Study Overview
Brief Summary
The objective of this study is to compare two surgical techniques for the treatment of the mandibular bone atrophies: Dense PTFE titanium-reinforced membranes (Group A) versus Titanium mesh covered with cross-linked collagen membranes (Group B).
Therefore, the main purposes are to compare test and control regarding (i) the percentage of post-operative complications (ii) the three-dimensional bone gain (iii) histological, histomorphometrical and microCT outcomes (iv) perImplant bone loss and soft tissue parameters.
Detailed Description
In the last 10 years, short- and long-term studies have demonstrated that GBR is a successful and reliable technique for vertical and horizontal ridge augmentation. GBR can be achieved with two different approaches: application of either a polytetrafluoroethylene (PTFE) titanium-reinforced membrane (i.e., a non-resorbable membrane) or a collagen membrane (i.e., a resorbable membrane). To achieve vertical bone augmentation, a resorbable membrane must be supported by a space-making device, such as a titanium mesh (Ti mesh) or a titanium osteosynthesis plate.
However, the use of a barrier device is a technique-sensitive procedure that is not free of complications. The main cause of GBR failure is related to early or late exposure of a barrier device, leading to contamination and infection of the biomaterial, irreversibly compromising bone regeneration.
This study aims to evaluate complication rates and vertical bone gain (VBG) after GBR with dense PTFE titanium-reinforced membranes versus with titanium mesh covered with cross-linked collagen membranes.
The primary objective of the study is, therefore, the evaluation of the healing complications; in particular, the early or delayed exposure of medical devices used for bone regeneration, during the healing period. This exposure is, as reported in all clinical studies, the main cause of the failure of the surgery. A secondary objective, is the quantitative assessment of bone regeneration obtained by the 2 techniques. In particular, the evaluation of the reconstructed bone volume (RBV) with respect to the planned bone volume (PBV). Other targets include the qualitative evaluation of bone regeneration through histological and histomorphometric analysis of the bone biopsies obtained at the moment that the medical device is removed and finally the evaluation of the peri-implant bone resorption will be conducted over time. This study was designed as a pilot, parallel-group, double-blind, randomized, comparative clinical trial. The study was conducted in accordance with the principles of the Declaration of Helsinki. The study was approved by the Ethical Committee of the Sant'Orsola-Malpighi Hospital (Prot. CMF 01/2013; number 30/2013/O/Disp).
The study included 40 patients with partial edentulism, associated with alveolar atrophy in the posterior regions of the mandible, who were referred to the Unit of Oral and Maxillofacial Surgery, Alma Mater Studiorum, University of Bologna, Italy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The surgeon is masked until the envelope is opened at the time of the surgery.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •edentulism in posterior regions of the mandible with vertical and horizontal bone resorption of the alveolar ridge requiring three-dimensional bone regeneration and implant-supported rehabilitation
- •a vertical peri-implant bone defect of ≥ 2 mm in the alveolar ridge that must be regenerated after placement of implants in a three-dimensional 'ideal' position;
- •capacity to understand and accept the conditions of the study; and 4 continuing participation in the study for at least 1 year of follow up.
Exclusion Criteria
- •residual bone height < 5 mm;
- •insufficient oral hygiene;
- •a smoking habit of > 10 cigarettes/day;
- •abuse of alcohol or drugs;
- •pregnancy;
- •acute local or systemic infection;
- •uncontrolled diabetes or other metabolic disease;
- •severe hepatic or renal dysfunction; HIV, HBV, or HCV;
- •chemotherapy or radiotherapy within the last 5 years;
- •immunosuppression therapy;
- •autoimmune disorders;
- •bisphosphonate therapy
Outcomes
Primary Outcomes
The rate of healing complications after reconstructive surgery
Time Frame: 6 months
Healing complications are evaluated based on the chronological order in which they occur:• immediate exposure occurs within the 1st month * early exposure occurs between the 1st and the 3rd month * late exposure occurs between after the 3rd month Evaluation of low-grade and high-grade infection of medical devices used for bone regeneration. The former complications are classified as: * Class A, including flap damage (soft tissue perforation or laceration) * Class B, including neurological damage (paresthesia or disesthesia) * Class C,including vascular damage (hemorrhage). The latter complications are divided into four classes, according to the presence and extent of exposure, as well as the presence of a purulent exudate: * Class I, membrane exposure \<3 mm, no purulent exudate * Class II membrane exposure \>=3mm, no purulent exudate * Class III: membrane exposure, with purulent exudate
Secondary Outcomes
- Width of keratinized mucosa (wKT)(at 1 years)
- Vertical bone gain(at 6 months)
- Bone tissue area (B.ar)(at 6 months)
- Bone volume (B.V)(at 6 months)
- Implants Insertion Torque(during surgery)
- Peri-implant bone level (PBL)(at 1 years)
- Thickness of keratinized tissue (tKT)(at 1 years)
- Probing pocket depth (PPD)(at 1 years)
- Inter-proximal bone peaks (IBP)(at 1 years)
- Change in implant Stability(during surgery/after 6 months)
Investigators
Alessandro Cucchi
Doctor
GBR Academy