Clinical trial NCT01728844: GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
Official title: A Randomized, Double-Blind, Controlled, Multicenter Dose Verification Clinical Trial to Evaluate the Safety and Effectiveness of GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Loss
Periodontal Diseases
Keywords: bone grafting
alveolar bone loss
periodontal diseases
Lead sponsor: Sunstar Americas
Sponsor class: INDUSTRY
First posted: 2012-11-20
Enrollment: 88
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: GUIDOR Growth Factor Enchanted Bone Graft Substitute (GFeBGS) when used in periodontal surgery will shown greater gum and bone regeneration when compare to bone graft substitute alone. Also, to find the optimal dose.

Detailed description: This will be a prospective, randomized, double-blinded, controlled, multi-center, dose-verification clinical study in subjects who require surgical intervention to treat a qualifying periodontal defect.

Subjects 25 years and older with advanced periodontal disease in at least one site requiring surgical treatment to correct a bone defect.

Eligibility criteria: Inclusion Criteria:

* Male or female, age of 25 and older
* Must have read, understood, and signed a consent form
* Must be able and willing to follow study procedures and instructions
* Must have undergone thorough scaling and root planing of the target tooth and be expected to demonstrate good plaque control after instruction in oral hygiene
* The target tooth must exhibit the following:

  * A pocket depth of 7 mm or greater
  * After surgical debridement, 4 mm or greater intrabony defect with at least 1 bony wall
  * Sufficient keratinized tissue to allow complete tissue coverage of the defect
  * Radiographic base of defect at least 3 mm coronal to the apex of the tooth

Exclusion Criteria:

* Failure to maintain adequate oral hygiene during the screening phase
* Women of child-bearing potential
* A history within the last 6 months of HIV, Type IV heart disease, or end-stage renal disease
* A history of oral cancer or any other cancer (exception: subjects with a history of skin cancers such as squamous and basal carcinoma with end of treatment at least 6 months ago and/or prostate cancer with end of treatment at least 5 years ago may be enrolled)
* A history within 12 months of previous open flap periodontal surgery on the study tooth.
* A diagnosis of pre-malignant oral lesion(s)
* A traumatic occlusion of the target tooth
* Target "study" tooth exhibiting Grade III mobility
* Maxillary molars or maxillary first premolar with a prominent mesial concavity
* Study tooth exhibiting a Class II or greater furcation defect
* Clinical or radiographic signs of untreated acute or chronic periapical infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cervical enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, or restorations with open or otherwise defective margins at or below the CEJ
* A history within the last 6 months of the daily use of any tobacco products besides cigarettes (smokeless chewing tobacco, pipe or cigar smoking), or of smoking more than 10 cigarettes per day
* Subjects participating in other clinical trials within 30 days of enrollment
* Subjects having uncontrolled endocrine-induced diseases (e.g. uncontrolled diabetes mellitus and hyperparathyroidism)
* Subjects undergoing current therapy with systemic steroids or other drugs that significantly alter bone metabolism
* Subjects with Localized Juvenile Periodontitis (LJP) sites in the oral cavity

Primary outcomes:
measure: Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
timeFrame: 6 months post-surgery
Secondary outcomes:
measure: Change in Clinical Attachment Level at 3 Months
timeFrame: Baseline and 3 months post-surgery
measure: Change in Clinical Attachment Level at 6 Months
timeFrame: Baseline and 6 months post-surgery
measure: Linear Bone Growth at 6 Months
timeFrame: Baseline and 6 months post-surgery
measure: Percent Bone Fill at 6 Months
timeFrame: Baseline and 6 months post-surgery
measure: Pocket Depth Change at 3 Months
timeFrame: Baseline and 3 months post-surgery
measure: Pocket Depth Change at 6 Months
timeFrame: Baseline and 6 months post-surgery
measure: Change in Gingival Recession at 3 Months
timeFrame: Baseline and 3 months post-surgery
measure: Change in Gingival Recession at 6 Months
timeFrame: Baseline and 6 months post-surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fullerton
country: United States
facility: Regenerative Solutions
state: California
city: Aurora
country: United States
facility: Drs. McClain and Schallhorn
state: Colorado
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Houston
country: United States
facility: Perio Health Professionals
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Sciences Center at San Antonio
name: David L. Cochran, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cochran DL, Oh TJ, Mills MP, Clem DS, McClain PK, Schallhorn RA, McGuire MK, Scheyer ET, Giannobile WV, Reddy MS, Abou-Arraj RV, Vassilopoulos PJ, Genco RJ, Geurs NC, Takemura A. A Randomized Clinical Trial Evaluating rh-FGF-2/beta-TCP in Periodontal Defects. J Dent Res. 2016 May;95(5):523-30. doi: 10.1177/0022034516632497. Epub 2016 Feb 23.