Clinical trial NCT02127112: Ridge Augmentation Comparing a Block Allograft to a Demineralized Bone Matrix Allograft.
Official title: Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus Optecure Containing Cortico-Cancellous Chips Versus Optecure Containing Cortico-Cancellous Chips Alone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alveolar Process Defect
Keywords: Ridge Augmentation
Bone regeneration
Guided Bone Regeneration
Partially Edentulous
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study with compare the ridge dimension changes for a block allograft vs. a demineralized bone matrix moldable allograft.

Detailed description: The patients' treatment will be randomly assigned by coin toss done by the mentor immediately after flap reflection. The examiner will be blinded to the treatment and will not have access to information indicating treatment assignment. The examiner will never see the patient between the time of grafting and complete healing at 4 months. The surgical procedure will consist of the reflection of a split-thickness flap to expose the alveolar ridge. Following complete exposure of the surgical site, vertical measurements will be taken with the acrylic occlusal stent in place, and horizontal measurements with a specially designed digital caliper. After initial surgical measurements, numerous cortical perforations will be performed with a round bur in the area of the augmentation. The control group will receive a block graft and bone screw for stabilization, with voids being filled by the Optecure+CCC®. The test group therapy will include graft with the Optecure+CCC® and the use of Bone Pin® for space maintenance. Horizontal dimension will be established by graft dimensions, bone screws, or bone pins when necessary, for each planned implant area. Longer span edentulous spaces will be divided into individual sites as follows: 5 mm from natural teeth to future mid-implant sites and 7 mm between two future mid-implant sites. The bone pins and bone blocks with bone screws will be placed to allow enough exposure for augmentation to achieve 9 mm horizontal width available for implant placement. Vertical and horizontal measurements will again be taken with the acrylic occlusal stent and calipers prior to flap closure. An resorbable membrane will cover both test and control groups. A monofilament suture material will be used. The surgical procedures will be documented with clinical photographs.

Eligibility criteria: Inclusion Criteria:

* At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
* Healthy person that is at least 18 years old.
* Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

* Patients with debilitating systemic diseases, diseases that significantly affect the periodontium, or psychological problems that would interfere with treatment.
* Previous head and neck radiation or chemotherapy within the previous 12 months.
* Patients with known allergy to any of the materials that will be used in the study.
* Smokers.
* Patients who need prophylactic antibiotics prior to dental procedures.
* Patients on long-term steroid therapy or oral bisphosphonates \> 3 years or any IV bisphosphonates.
* Patients who are pregnant

Primary outcomes:
measure: Site width (horizontal) changes by comparing the pre- to post-augmentation dimensions of hard tissues.
timeFrame: 4 months
Secondary outcomes:
measure: Site height (vertical) changes by comparing the pre- to the post-augmentation dimensions of hard tissues.
timeFrame: 4 months
measure: Histologic composition of the healed ridge.
timeFrame: 4 month
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Graduate Periodontics Clinic, University of Louisville
state: Kentucky
city: Louisville
country: United States
facility: U of L Dental School
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Henry Greenwell, DMD, MSD
role: PRINCIPAL_INVESTIGATOR
References: