GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery

Sunstar

Status: Completed

Conditions: Periodontal Diseases; Alveolar Bone Loss

Treatments: Device: GFeBGS 0.4%; Device: GFeBGS 0.1%; Device: GFeBGS 0.3%; Device: beta-tricalcium phosphate alone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01728844

CLP-2011-10-31-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 4 patient groups

beta-tricalcium phosphate alone

Active Comparator group

Description:

beta-tricalcium phosphate alone

Treatment:

Device: beta-tricalcium phosphate alone

GFeBGS 0.1%

Experimental group

Description:

GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)

Treatment:

Device: GFeBGS 0.1%

GFeBGS 0.3%

Experimental group

Description:

GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF

Treatment:

Device: GFeBGS 0.3%

GFeGBS 0.4%

Experimental group

Description:

GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF

Treatment:

Device: GFeBGS 0.4%