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

NCT06286605 | Not Yet Recruiting

• 1 other identifier: UNISS_PHD_Osstem_4
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Guided Bone Regeneration; Dental Implant

Keywords

Dental Implant; GBR

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  Up to 5 years

Secondary Outcomes (6)

• Horizontal and volumetric dimensional changes

  6 and 12 months

• Rate of peri-implant marginal bone level

  At 1,3 and 5 years

• Plaque Index and bleeping on probing

  At 1,3 and 5 years

• Valuation of patient satisfaction

  At 1,3 and 5 years

• Valuation of soft tissue thickness and amount of keratinized tissue

  At 1,3 and 5 years

Study Arms (2)

A-oss and autogenous bone

EXPERIMENTAL

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.

Procedure: A-oss and autogenous bone

A-oss and LCR-A

ACTIVE COMPARATOR

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

Procedure: A-oss an LCR-A

Interventions

A-oss and autogenous bone PROCEDURE

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

A-oss and autogenous bone

A-oss an LCR-A PROCEDURE

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

A-oss and LCR-A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead
• Melodia, Dario, M.D.: collaborator
• Pisano, Milena, M.D.: collaborator
• Dr. Aurea Lumbau: collaborator
• Prof. Silvio Mario Meloni: collaborator
• Prof. Edoardo Baldoni: collaborator

Study Sites (1)

Marco Tallarico

Sassari, 07100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aisstent Professor

Model Details: Multicenter, randomized controlled trial of parallel-group design.

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: February 29, 2024
• Study Start: March 1, 2024
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)