Horizontal Ridge Augmentation With or Without Autogenous Block Grafts

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432702
• Other study ID #: 00013
• Status: Completed
• Phase: N/A
• First received: January 31, 2018
• Last updated: February 7, 2018
• Start date: May 1, 2012
• Est. completion date: June 1, 2017

Study information

• Verified date: February 2018
• Source: Universidad Científica del Sur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 1, 2017
• Est. primary completion date: September 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Peru	Periodontal Postgraduate Clinic at the Faculty of Dentistry, Científica del Sur University	Lima

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Científica del Sur	New York University School of Medicine

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Complications	Assessments of complications related to study procedures will be recorded during the follow up period.	6 months
Secondary	Regrafting necessity	Number of implants that needed regrafting to allow for ideal prosthetically driven implant placement.	At 6 months (T6).