Bone Regeneration, Bone Substitutes, Bone Transplantation, Cone-beam Computed Tomography, Dental Implants
Conditions
Brief summary
To evaluate dimensional bone alterations following horizontal ridge augmentation using guided bone regeneration (GBR) with or without autogenous block graft (ABG) for the rehabilitation of atrophic jaws with dental implants.
Detailed description
Forty-two patients with 42 severe horizontal bone atrophy sites in the maxilla or mandible will be randomly assigned to two groups: ABG or GBR. In the ABG group, a combination of ABG with particulate xenograft, covered with collagen membrane, will be used, while only a combination of particulate xenograft and collagen membrane alone will be in the GBR group. After 6-9 months of healing, implants were inserted. All implants will be definitively restored 6 months after implant placement. Radiographic examination (cone beam computed tomograms, CBCT) will be performed to evaluate the amount of horizontal bone width (HBW) gain immediately after bone grafting procedure (T0), at 6 months (T6), and at 18 months (T18). Patient demographic information, amount of width augmentation, implant survival, complications, and contributing factors will be gathered and analyzed.
Interventions
PROCEDUREHorizontal ridge augmentation
Surgical procedures performed to provide the alveolar ridge with enough width and height to allow for the prosthetically driven implant placement.
Sponsors
NYU Langone Health
Universidad Científica del Sur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcome measurements will be recorded by an examiner, who will not participate in any study procedure, and will be blind to the allocated treatment. This blinded examiner will be trained and calibrated to perform measurements. A dentist who is blinded to the treatment protocol will performe all radiographic measurements.
Intervention model description
Single center, prospective, controlled, parallel-armed, randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years old, who required an implant supported restoration in at least one site, with severe atrophy of the alveolar ridge in the horizontal plane (class III-IV atrophy according to Cawood and Howell classification), * adequate oral hygiene * no history of previous bone augmentation procedures at the implant site, and * able to understand and sign an informed consent form.
Exclusion criteria
* uncontrolled systemic conditions, irradiation in the head and neck area, - immunosuppressed or immunocompromised, * presented with oral disorders (such as lichen planus), * treated or under treatment with intravenous amino-bisphosphonates, * untreated periodontitis, poor oral hygiene and motivation, * parafunctional habits, * pregnant or lactating, * drug or alcohol abuse, * psychiatric disorders, * a history (within the last 3 months) of using (at least weekly or more frequently) smokeless chewing tobacco, smoking a pipe, cigar or cigarette (at a rate of more than 10 cigarettes per day), * acute/chronic infection/inflammation in the area, or * an extraction with less than 3 months of healing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in horizontal alveolar ridge width from pre-operatively (baseline) to 12 months after implant loading. | From pre-operatively (baseline) to 12 months after implant loading. | Horizontal alveolar ridge changes in being assessed in the regenerated area. This outcome will be evaluated from pre-operatively (baseline), to 12 months after implant loading by measuring the alveolar ridge width at various points on the cross-sectional images using data obtained from CBCT scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant failure | At 6 months (T6), and at 18 months (T18) after implant placement. | The presence of an implant that requires implant removal (e.g., implant mobility). |
| Complications | 6 months | Assessments of complications related to study procedures will be recorded during the follow up period. |
| Regrafting necessity | At 6 months (T6). | Number of implants that needed regrafting to allow for ideal prosthetically driven implant placement. |
Countries
Peru
Outcome results
None listed