RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A
NCT ID: NCT06286605
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
42 participants
INTERVENTIONAL
2024-03-01
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A-oss and autogenous bone
In these group a GBR will be performed using only A-oss and autologous bone will be added and then will be covered with a membrane.
A-oss and autogenous bone
Horizontal ridge augmentation in one stages approach will be performed using a mix of A-Oss and autologenous bone.
A-oss and LCR-A
In these subjects a GBR will be performed using only A-oss and LCR-A and then will be covered with a membrane.
A-oss an LCR-A
Horizontal ridge augmentation in one stages approach will be performed using OssMem with A-Oss and LCR-A
Interventions
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A-oss and autogenous bone
Horizontal ridge augmentation in one stages approach will be performed using a mix of A-Oss and autologenous bone.
A-oss an LCR-A
Horizontal ridge augmentation in one stages approach will be performed using OssMem with A-Oss and LCR-A
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Melodia, Dario, M.D.
INDIV
Pisano, Milena, M.D.
INDIV
Dr. Aurea Lumbau
UNKNOWN
Prof. Silvio Mario Meloni
UNKNOWN
Prof. Edoardo Baldoni
UNKNOWN
Università degli Studi di Sassari
OTHER
Responsible Party
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Marco Tallarico
Aisstent Professor
Locations
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Marco Tallarico
Sassari, , Italy
Countries
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Facility Contacts
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Dario Melodia, Dr
Role: primary
Marco Tallarico, Prof
Role: backup
Other Identifiers
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UNISS_PHD_Osstem_4
Identifier Type: -
Identifier Source: org_study_id