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Not yet recruiting NCT06286605

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

No phase Interventional Guided Bone Regeneration Dental Implant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A-oss and autogenous bone, A-oss an LCR-A.
Who it may be relevant to
Registry conditions: Guided Bone Regeneration, Dental Implant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

  • Procedure A-oss and autogenous bone
    Horizontal ridge augmentation in one stages approach will be performed using a mix of A-Oss and autologenous bone.
  • Procedure A-oss an LCR-A
    Horizontal ridge augmentation in one stages approach will be performed using OssMem with A-Oss and LCR-A

Primary outcome measures

  • Rate of Implants survival [Time frame: Up to 5 years]
  • Number of Participants with prosthesis failure [Time frame: Up to 5 years]
  • Number of complications [Time frame: Up to 5 years]
Secondary outcome measures (6)
  • Horizontal and volumetric dimensional changes [Time frame: 6 and 12 months]
  • Rate of peri-implant marginal bone level [Time frame: At 1,3 and 5 years]
  • Plaque Index and bleeping on probing [Time frame: At 1,3 and 5 years]
  • Valuation of patient satisfaction [Time frame: At 1,3 and 5 years]
  • Valuation of soft tissue thickness and amount of keratinized tissue [Time frame: At 1,3 and 5 years]
  • Rate of pes score [Time frame: At 1,3 and 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Marco Tallarico — Sassari

Identifiers

NCT: NCT06286605 · UNISS_PHD_Osstem_4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗