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

Not Applicable

Completed

Conditions: Alveolar Bone Loss
Periodontal Diseases

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

Registration Number: NCT01728844

Lead Sponsor: Sunstar Americas

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 88

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GFeBGS 0.1%	GFeBGS 0.1%	GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
beta-tricalcium phosphate alone	beta-tricalcium phosphate alone	beta-tricalcium phosphate alone
GFeBGS 0.3%	GFeBGS 0.3%	GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
GFeGBS 0.4%	GFeBGS 0.4%	GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF

Primary Outcome Measures

Name	Time	Method
Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements	6 months post-surgery	The primary effectiveness endpoint is a composite endpoint that considers radiographic and clinical measurements at six months post-implantation: the amount of linear bone growth (LBG), which is assessed with the use of radiographs, and the regain from baseline of clinical attachment level (∆CAL), which is assessed clinically. Linear bone growth (LBG) in a vertical and horizontal direction is determined radiographically at six months post-implantation. The clinical attachment level (CAL) is the distance from the cemento-enamel junction (CEJ) (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. The success criteria are ΔCAL ≥1.5 mm and LBG ≥1 mm at 6 months after the treatment. Both the ∆CAL and LBG must meet the success criteria for a subject to be considered a success.

Secondary Outcome Measures

Name	Time	Method
Change in Clinical Attachment Level at 6 Months	Baseline and 6 months post-surgery	The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (6 months measurement - Baseline measurement)
Linear Bone Growth at 6 Months	Baseline and 6 months post-surgery	Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Linear Bone Growth = (Baseline measurement - 6 months measurement)
Pocket Depth Change at 6 Months	Baseline and 6 months post-surgery	Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (6 months measurement - Baseline measurement)
Change in Clinical Attachment Level at 3 Months	Baseline and 3 months post-surgery	The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (3 months measurement - Baseline measurement)
Percent Bone Fill at 6 Months	Baseline and 6 months post-surgery	Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Percent Bone Fill is calculated by dividing Linear Bone Growth at 6 months by bone height at baseline.
Pocket Depth Change at 3 Months	Baseline and 3 months post-surgery	Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (3 months measurement - Baseline measurement)
Change in Gingival Recession at 3 Months	Baseline and 3 months post-surgery	Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (3 months measurement - Baseline measurement)
Change in Gingival Recession at 6 Months	Baseline and 6 months post-surgery	Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (6 months measurement - Baseline measurement)

Trial Locations

Locations (6): Drs. McClain and Schallhorn
🇺🇸
Aurora, Colorado, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Perio Health Professionals
🇺🇸
Houston, Texas, United States
Regenerative Solutions
🇺🇸
Fullerton, California, United States
University of Texas Health Science Center at San Antonio
🇺🇸
San Antonio, Texas, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States