Horizontal Ridge Augmentation With or Without Autogenous Block Grafts

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implants; Bone Regeneration; Cone-beam Computed Tomography; Bone Substitutes; Bone Transplantation
• Intervention / Treatment: Procedure: Horizontal ridge augmentation

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in horizontal alveolar ridge width 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.	From pre-operatively (baseline) to 12 months after implant loading.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant failure	The presence of an implant that requires implant removal (e.g., implant mobility).	At 6 months (T6), and at 18 months (T18) after implant placement.
Complications	Assessments of complications related to study procedures will be recorded during the follow up period.	6 months
Regrafting necessity	Number of implants that needed regrafting to allow for ideal prosthetically driven implant placement.	At 6 months (T6).

Collaborators and Investigators

• Sponsor: Universidad Científica del Sur
• Collaborators: NYU Langone Health
• Investigators: Principal Investigator: Gerardo Mendoza-Azpur, DDS, Científica del Sur University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 7, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 00013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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