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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità degli Studi di Sassari

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • A-oss and autogenous bone

    Procedure/Surgery

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

  • A-oss an LCR-A

    Procedure/Surgery

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

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: A-oss and autogenous boneExperimental treatment 1 intervention
Group B: A-oss and LCR-AActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

1

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.

Time frame
6 and 12 months
2

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.

Time frame
At 1,3 and 5 years
3

Plaque Index and bleeping on probing

Plaque index (PI), defined as plaque absent or present (0/1), and Bleeding on Probing (BoP), defined as bleeding on probing absent or present (0/1), will recorded 1,3 and 5 years after final prosthesis delivery. One assessor, not previously involved in the study, made all the clinical outcomes.

Time frame
At 1,3 and 5 years
4

Valuation of patient satisfaction

Patients will answer the following questions (separately for each implant): 1. Are you satisfied with the function of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. 2. Are you satisfied with the aesthetic outcome of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. 3. Would you undergo the same therapy again? Possible answers: "yes" or "no".1) Are you satisfied with the function of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. 2\) Are you satisfied with the aesthetic outcome of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. 3\) Would you undergo the same therapy again? Possible answers: "yes" or "no".

Time frame
At 1,3 and 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Università degli Studi di Sassari

Lead sponsor

Melodia, Dario, M.D.

Collaborator

Pisano, Milena, M.D.

Collaborator

Dr. Aurea Lumbau

Collaborator

Meloni, Silvio Mario, M.D.

Collaborator

Baldoni, Edoardo, M.D.

Collaborator

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