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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01728844
Other study ID # CLP-2011-10-31-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2012
Est. completion date August 2014

Study information

Verified date August 2020
Source Sunstar Americas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 88
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 25 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
beta-tricalcium phosphate alone

GFeBGS 0.1%

GFeBGS 0.3%

GFeBGS 0.4%


Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Drs. McClain and Schallhorn Aurora Colorado
United States University of Alabama at Birmingham Birmingham Alabama
United States Regenerative Solutions Fullerton California
United States Perio Health Professionals Houston Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Sunstar Americas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 ?CAL =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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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