Horizontal Ridge Augmentation With or Without Autogenous Block Grafts

Not Applicable

Completed

• Conditions: Bone Regeneration; Cone-beam Computed Tomography; Bone Transplantation; Bone Substitutes; Dental Implants
• Interventions: Procedure: Horizontal ridge augmentation

• Registration Number: NCT03432702
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-05-01
• Primary Completion: 2015-09-01
• Study Completion: 2017-06-01
• Study First Submitted: 2018-01-31
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-07
• Last Update Submitted: 2018-02-07
• Study First Posted: 2018-02-14
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alveolar ridge augmentation without ABG	Horizontal ridge augmentation	Horizontal ridge augmentation using guided bone regeneration without autogenous block graft (ABG)
Alveolar ridge augmentation with ABG	Horizontal ridge augmentation	Horizontal ridge augmentation using guided bone regeneration with autogenous block graft (ABG).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
Regrafting necessity	At 6 months (T6).	Number of implants that needed regrafting to allow for ideal prosthetically driven implant placement.
Complications	6 months	Assessments of complications related to study procedures will be recorded during the follow up period.

Trial Locations

Locations (1)

Periodontal Postgraduate Clinic at the Faculty of Dentistry, Científica del Sur University; 🇵🇪 Lima, Peru