Alveolar Bone LossNCT01728844
GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
A study testing beta-tricalcium phosphate alone, GFeBGS 0.1% and GFeBGS 0.3% in people with Alveolar Bone Loss and Periodontal Diseases, run by Sunstar Americas at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Alveolar Bone Loss, Periodontal Diseases
- What is being tested?
- beta-tricalcium phosphate alone, GFeBGS 0.1% and GFeBGS 0.3%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48106
Drs. McClain and Schallhorn
Aurora, Colorado, 80012
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Regenerative Solutions
Fullerton, California, 92835
Perio Health Professionals
Houston, Texas, 77063
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Conditions
- Alveolar Bone Loss, Periodontal Diseases
- Being tested
- beta-tricalcium phosphate alone, GFeBGS 0.1%, GFeBGS 0.3%, GFeBGS 0.4%
- Keywords
- bone grafting, alveolar bone loss, periodontal diseases
- Medical subject headings
- Alveolar Bone Loss, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta-tricalcium phosphate aloneDevice
GFeBGS 0.1%Device
GFeBGS 0.3%Device
GFeBGS 0.4%Device
| Study group | Role | What they receive |
|---|---|---|
| beta-tricalcium phosphate alone | Active comparator | beta-tricalcium phosphate alone Receives: 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) Receives: Device: GFeBGS 0.1% |
| GFeBGS 0.3% | Experimental | GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF Receives: Device: GFeBGS 0.3% |
| GFeGBS 0.4% | Experimental | GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF Receives: Device: GFeBGS 0.4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-surgery
Secondary outcomes (8)
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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunstar Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David L. Cochran, DDS, PhD, Principal investigator, University of Texas Health Sciences Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728844
- Sponsor's protocol ID
- CLP-2011-10-31-1
- Status last verified
- Aug 2020
- First submitted
- 1 Nov 2012
- Last updated
- 17 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 26908630
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01728844
- Acronym / sponsor ID
- CLP-2011-10-31-1
- Conditions
- Alveolar Bone Loss, Periodontal Diseases
- Keywords
- bone grafting, alveolar bone loss, periodontal diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Sunstar AmericasIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Posted 21 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| beta-tricalcium phosphate alone | Active comparator | Device: beta-tricalcium phosphate alonebeta-tricalcium phosphate alone |
| GFeBGS 0.1% | Experimental | Device: GFeBGS 0.1%GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF) |
| GFeBGS 0.3% | Experimental | Device: GFeBGS 0.3%GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF |
| GFeGBS 0.4% | Experimental | Device: GFeBGS 0.4%GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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% |
Primary outcome
Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
Time frame: 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.
8 secondary outcomes
Change in Clinical Attachment Level at 3 Months
Time frame: Baseline and 3 months post-surgery
Change in Clinical Attachment Level at 6 Months
Time frame: Baseline and 6 months post-surgery
Linear Bone Growth at 6 Months
Time frame: Baseline and 6 months post-surgery
Percent Bone Fill at 6 Months
Time frame: Baseline and 6 months post-surgery
Pocket Depth Change at 3 Months
Time frame: Baseline and 3 months post-surgery
Pocket Depth Change at 6 Months
Time frame: Baseline and 6 months post-surgery
Change in Gingival Recession at 3 Months
Time frame: Baseline and 3 months post-surgery
Change in Gingival Recession at 6 Months
Time frame: Baseline and 6 months post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26908630Cochran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L. Cochran, DDS, PhD principal investigator
University of Texas Health Sciences Center at San Antonio
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beta-tricalcium phosphate alone, GFeBGS 0.1% and GFeBGS 0.3% in people with Alveolar Bone Loss and Periodontal Diseases, run by Sunstar Americas at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements (time frame: 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01728844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.