Horizontal Ridge Augmentation With or Without Autogenous Block Grafts

U

Universidad Científica del Sur

Status

Completed

Conditions

Dental Implants
Bone Substitutes
Bone Transplantation
Cone-beam Computed Tomography
Bone Regeneration

Treatments

Procedure: Horizontal ridge augmentation

Study type

Interventional

Funder types

Other

Identifiers

NCT03432702
00013

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

42 participants in 2 patient groups

Alveolar ridge augmentation without ABG
Active Comparator group
Description:
Horizontal ridge augmentation using guided bone regeneration without autogenous block graft (ABG)
Treatment:
Procedure: Horizontal ridge augmentation
Alveolar ridge augmentation with ABG
Experimental group
Description:
Horizontal ridge augmentation using guided bone regeneration with autogenous block graft (ABG).
Treatment:
Procedure: Horizontal ridge augmentation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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