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Horizontal Ridge Augmentation With or Without Autogenous Block Grafts

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ClinicalTrials.gov Identifier: NCT03432702
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
New York University School of Medicine
Information provided by (Responsible Party):
Universidad Científica del Sur

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.

Condition or disease Intervention/treatment Phase
Bone Regeneration Bone Transplantation Bone Substitutes Cone-beam Computed Tomography Dental Implants Procedure: Horizontal ridge augmentation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center, prospective, controlled, parallel-armed, randomized clinical trial.
Masking: Double (Participant, 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.
Primary Purpose: Treatment
Official Title: Horizontal Ridge Augmentation With Guided Bone Regeneration Using Particulate Xenogenic Bone Substitutes With or Without Autogenous Block Grafts: A Randomized Controlled Trial
Actual Study Start Date : May 1, 2012
Actual Primary Completion Date : September 1, 2015
Actual Study Completion Date : June 1, 2017

Arm Intervention/treatment
Active Comparator: Alveolar ridge augmentation without ABG
Horizontal ridge augmentation using guided bone regeneration without autogenous block graft (ABG)
Procedure: Horizontal ridge augmentation
Surgical procedures performed to provide the alveolar ridge with enough width and height to allow for the prosthetically driven implant placement.
Other Names:
  • Alveolar ridge augmentation
  • Bone grafting

Experimental: Alveolar ridge augmentation with ABG
Horizontal ridge augmentation using guided bone regeneration with autogenous block graft (ABG).
Procedure: Horizontal ridge augmentation
Surgical procedures performed to provide the alveolar ridge with enough width and height to allow for the prosthetically driven implant placement.
Other Names:
  • Alveolar ridge augmentation
  • Bone grafting




Primary Outcome Measures :
  1. Changes in horizontal alveolar ridge width from pre-operatively (baseline) to 12 months after implant loading. [ Time Frame: 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 Outcome Measures :
  1. Implant failure [ Time Frame: 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).

  2. Complications [ Time Frame: 6 months ]
    Assessments of complications related to study procedures will be recorded during the follow up period.

  3. Regrafting necessity [ Time Frame: At 6 months (T6). ]
    Number of implants that needed regrafting to allow for ideal prosthetically driven implant placement.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432702


Locations
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Peru
Periodontal Postgraduate Clinic at the Faculty of Dentistry, Científica del Sur University
Lima, Peru
Sponsors and Collaborators
Universidad Científica del Sur
New York University School of Medicine
Investigators
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Principal Investigator: Gerardo Mendoza-Azpur, DDS Científica del Sur University

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Responsible Party: Universidad Científica del Sur
ClinicalTrials.gov Identifier: NCT03432702     History of Changes
Other Study ID Numbers: 00013
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No