Bone Loss Clinical Trial
Official title:
Guided Bone Regeneration With Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes.
Verified date | March 2020 |
Source | GBR Academy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 1, 2019 |
Est. primary completion date | September 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | School of Dentistry - University of Bologna | Bologna |
Lead Sponsor | Collaborator |
---|---|
GBR Academy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of healing complications after reconstructive surgery | 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 |
6 months | |
Secondary | Implants Insertion Torque | measured with a manual dynamometric torque wrench, able to measure torques up to 100 Ncm | during surgery | |
Secondary | Change in implant Stability | Change from implant stability during surgery and at 6 months was evaluated using the implant stability quotient recorded during surgery and after 6 months during reopening surgery | during surgery/after 6 months | |
Secondary | Vertical bone gain | calculated as the difference between the initial bone defect and the residual bone defect expressed in millimeters (mm). | at 6 months | |
Secondary | Bone tissue area (B.ar) | evaluated as the total area of regenerated bone performed with a digital microscopic evaluation. | at 6 months | |
Secondary | Bone volume (B.V) | evaluated as the total volume of the regenerated bone performed with a MicroCT evaluation. | at 6 months | |
Secondary | Peri-implant bone level (PBL) | was evaluated as the distance between the implant shoulder and the visible bone crest on periapical radiograph using a parallel technique. The distance was measured to the nearest 0.01 mm using an image analysis software (Image J, NIH). | at 1 years | |
Secondary | Inter-proximal bone peaks (IBP) | was evaluated as the distance between the interproximal bone peak and the "ideal" regeneration line on periapical radiograph using a parallel technique. The distance was measured to the nearest 0.01 mm using an image analysis software (Image J, NIH) | at 1 years | |
Secondary | Probing pocket depth (PPD) | The probing depth was measured from the gingival margin at the base of the groove or pocket in the central and distal mesial sites, using the calibrated Click-probe millimeter probe 3/5/7/10 mm scale | at 1 years | |
Secondary | Thickness of keratinized tissue (tKT) | The thickness of the soft tissues was determined apically at the gingival margin using a file for endodontic therapy measures 8 and with a 3 mm diameter silicone disk with a stop function | at 1 years | |
Secondary | Width of keratinized mucosa (wKT) | The height of the keratinized mucosa was determined by the gingival margin at the vestibular muco-gingival line | at 1 years |
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