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

Università degli Studi di Sassari

Status: Not yet enrolling

Conditions: Dental Implant; Guided Bone Regeneration

Treatments: Procedure: A-oss and autogenous bone; Procedure: A-oss an LCR-A

Study type: Interventional

Funder types: Other

Identifiers

NCT06286605

UNISS_PHD_Osstem_4

Details and patient eligibility

About

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).

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

A-oss and autogenous bone

Experimental group

Description:

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.

Treatment:

Procedure: A-oss and autogenous bone

A-oss and LCR-A

Active Comparator group

Description:

In these subjects a GBR will be performed using only A-oss and LCR-A and then will be covered with a membrane.

Treatment:

Procedure: A-oss an LCR-A