Clinical trial NCT06286605: RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A
Official title: Horizontal Ridge Augmentation Using One-stage Guided Bone Regeneration (GBR) for Bone Defect Class IV of Cawed and Howell With Collagene Membrane (OssMem) and a Mix of Bovine Bone Substitute (A-Oss) and Autogenous Bone Versus A-Oss and LCR-A, a Synthetic Bone : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Guided Bone Regeneration
Dental Implant
Keywords: Dental Implant
GBR
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
Collaborators: name: Melodia, Dario, M.D.
name: Pisano, Milena, M.D.
name: Dr. Aurea Lumbau
name: Prof. Silvio Mario Meloni
name: Prof. Edoardo Baldoni
First posted: 2024-02-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized controlled trial of parallel-group design.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Implants survival
timeFrame: Up to 5 years
measure: Number of Participants with prosthesis failure
timeFrame: Up to 5 years
measure: Number of complications
timeFrame: Up to 5 years
Secondary outcomes:
measure: Horizontal and volumetric dimensional changes
timeFrame: 6 and 12 months
measure: Rate of peri-implant marginal bone level
timeFrame: At 1,3 and 5 years
measure: Plaque Index and bleeping on probing
timeFrame: At 1,3 and 5 years
measure: Valuation of patient satisfaction
timeFrame: At 1,3 and 5 years
measure: Valuation of soft tissue thickness and amount of keratinized tissue
timeFrame: At 1,3 and 5 years
measure: Rate of pes score
timeFrame: At 1,3 and 5 years
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Marco Tallarico
Study officials:
References: