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OpenTrials
Completed

NCT Number: NCT03432702

Horizontal Ridge Augmentation With or Without Autogenous Block Grafts

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Periodontal Postgraduate Clinic at the Faculty of Dentistry, Científica del Sur University

Lima, Peru

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Horizontal Ridge augmentation

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Científica del Sur

Other

Collaborators

  • NYU Langone Health

Registry information

Official study title

Horizontal Ridge Augmentation With Guided Bone Regeneration Using Particulate Xenogenic Bone Substitutes With or Without Autogenous Block Grafts: A Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Feb 14, 2018
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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