RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A

N/ANot Yet RecruitingNCT06286605

Università degli Studi di Sassari42 enrolled

Overview

The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Guided Bone Regeneration Dental Implant

Interventions

A-oss and autogenous bonePROCEDURE

Horizontal ridge augmentation in one stages approach will be performed using a mix of A-Oss and autologenous bone.

A-oss an LCR-APROCEDURE

Horizontal ridge augmentation in one stages approach will be performed using OssMem with A-Oss and LCR-A

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients that required an implant supported restoration and staged horizontal guided bone regeneration (defect of class IV according to Cawed and Howell) in both mandible or maxilla. * Patents able to understand and sign an informed consent. * Patients were to be 18 years or older with a residual horizontal ridge thickness of 4 mm or less (Cawood-Howell Class III- IV) in the intended implant site. * Smokers will be categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Only categories 1 and 2 will be included. Exclusion Criteria: * General contraindications to implant surgery. * Patients irradiated in the head and neck area. * Immunosuppressed or immunocompromised patients. * Patients treated or under treatment with intravenous amino-bisphosphonates. * Patients with untreated periodontitis. * Patients with poor oral hygiene and motivation. * Uncontrolled diabetes. * Pregnancy or nursing. * Substance abuser. * Heavy smokers (smoking more than 11 cigarettes/day). * Psychiatric problems or unrealistic expectations. * Lack of opposite occluding dentition in the area intended for implant placement. * Immediate implants (extractive sites will have to be healed from 6-8 weeks). * Patients participating in other studies, if the present protocol cannot be properly adhered to. * Patients referred only for implant placement and cannot be followed ant the treating centre. * Patients unable to be followed for 5 years

Locations (1)

Marco Tallarico

Sassari, Italy

Outcomes

Primary Outcomes

Rate of Implants survival

Defined as implant mobility and/or any infection dictating implant removal, and/or implant fracture and/or any other mechanical complication rendering the implant unusable. The stability of each individual implant will be measured by the local blinded outcome assessors manually tightening the screws with a torque of 30 Ncm at abutment connection at initial loading. At 1,3 and 5 years after loading, individual implants will be manually tested for stability. Once the single crowns will be screwed, their stability will be assessed by rocking the crown with the handles of two dental instruments

Time frame: Up to 5 years

Number of Participants with prosthesis failure

Whether it will not be possible to place the prosthesis because of implant failure or a prosthesis that has to be remade for any reason.

Time frame: Up to 5 years

Number of complications

Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, mobility, membrane exposure, suppuration) complications will be considered

Time frame: Up to 5 years

Secondary Outcomes

Horizontal and volumetric dimensional changes

CBCT scans will perform before ridge reconstruction and six months after. The Digital Imaging and Communication in Medicine (DICOM) data will export the OnDemand 3D software version 1.0.9.3223 (Cybermed Inc., Seoul, Korea) to perform all measurements. The DICOM data were manually alined basic on unchanged anatomical areas (e.g., teeth, basal skull, implants) and then automatically matched using the Fusion adjunctive module (Cybermed Inc. Seoul, Korea). Horizontal bone measure will recorded for all reconstructed ridge 2 mm below the bone crest, before and after treatment. Then, the postoperative volumetric data were subtracted to the original scenario. The new generated set of DICOM data will stored as a separately files. Volumetric measurements of grafts were performed with OnDemand 3D software (Cybermed Inc., Seoul, Korea) using the previously generated set of DICOM data.The volumes of the grafted material will calculated using automatic tools, basing on its opacity.

Data from ClinicalTrials.gov

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Time frame: 6 and 12 months

Rate of peri-implant marginal bone level

Peri-implant marginal bone level changes will be assessed on periapical radiographs took with the paralleling technique at implant placement, at initial loading, 1,3 and 5 years after loading. Ideally digital radiographs should be taken, otherwise radiographs on conventional films will be scanned into TIFF format with a 600 dpi resolution, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the first two consecutive threads. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. Bone levels will be measured.