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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Alveolar Bone Loss
• Intervention / Treatment: Device: beta-tricalcium phosphate alone; Device: GFeBGS 0.1%; Device: GFeBGS 0.3%; Device: GFeBGS 0.4%

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Fullerton, California, United States, 92835
      • Regenerative Solutions
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Drs. McClain and Schallhorn
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan
  • Texas
    • Houston, Texas, United States, 77063
      • Perio Health Professionals
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: beta-tricalcium phosphate alone	Device: beta-tricalcium phosphate alone
Experimental: GFeBGS 0.1%; GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)	Device: GFeBGS 0.1%
Experimental: GFeBGS 0.3%; GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF	Device: GFeBGS 0.3%
Experimental: GFeGBS 0.4%; GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF	Device: GFeBGS 0.4%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements	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.	6 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Attachment Level at 3 Months	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)	Baseline and 3 months post-surgery
Change in Clinical Attachment Level at 6 Months	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)	Baseline and 6 months post-surgery
Linear Bone Growth at 6 Months	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)	Baseline and 6 months post-surgery
Percent Bone Fill at 6 Months	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.	Baseline and 6 months post-surgery
Pocket Depth Change at 3 Months	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)	Baseline and 3 months post-surgery
Pocket Depth Change at 6 Months	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)	Baseline and 6 months post-surgery
Change in Gingival Recession at 3 Months	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)	Baseline and 3 months post-surgery
Change in Gingival Recession at 6 Months	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)	Baseline and 6 months post-surgery

Collaborators and Investigators

• Sponsor: Sunstar Americas
• Investigators: Principal Investigator: David L. Cochran, DDS, PhD, University of Texas Health Sciences Center at San Antonio

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: November 1, 2012
• First Submitted That Met QC Criteria: November 16, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: alveolar bone loss; bone grafting; periodontal diseases
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Periodontal Diseases; Alveolar Bone Loss
• Other Study ID Numbers: CLP-2011-10-31-1