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

NCT01728844 | Completed Results

• 1 other identifier: CLP-2011-10-31-1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 6

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.

Conditions

Alveolar Bone Loss; Periodontal Diseases

Keywords

bone grafting; alveolar bone loss; periodontal diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in Clinical Attachment Level at 3 Months

  Baseline and 3 months post-surgery

• Change in Clinical Attachment Level at 6 Months

  Baseline and 6 months post-surgery

• Linear Bone Growth at 6 Months

  Baseline and 6 months post-surgery

• Percent Bone Fill at 6 Months

  Baseline and 6 months post-surgery

• Pocket Depth Change at 3 Months

  Baseline and 3 months post-surgery

Study Arms (4)

beta-tricalcium phosphate alone

ACTIVE COMPARATOR

beta-tricalcium phosphate alone

Device: beta-tricalcium phosphate alone

GFeBGS 0.1%

EXPERIMENTAL

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

Device: GFeBGS 0.1%

GFeBGS 0.3%

EXPERIMENTAL

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

Device: GFeBGS 0.3%

GFeGBS 0.4%

EXPERIMENTAL

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

Device: GFeBGS 0.4%

Interventions

beta-tricalcium phosphate alone DEVICE

beta-tricalcium phosphate alone

GFeBGS 0.1% DEVICE

GFeBGS 0.1%

GFeBGS 0.3% DEVICE

GFeBGS 0.3%

GFeBGS 0.4% DEVICE

GFeGBS 0.4%

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunstar Americas: lead

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Regenerative Solutions

Fullerton, California, 92835, United States

Location

Drs. McClain and Schallhorn

Aurora, Colorado, 80012, United States

Location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Perio Health Professionals

Houston, Texas, 77063, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 26908630 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss; Periodontal Diseases

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Akane Takemura
• Organization: Sunstar Americas, Inc.

akane.takemura@us.sunstar.com

8477944276

Study Officials

• David L. Cochran, DDS, PhD

  University of Texas Health Sciences Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 20, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 17, 2020
• Results First Posted: August 21, 2020

Record last verified: 2020-08

Locations

US (6)