GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
27. august 2020 oppdatert av: Sunstar Americas
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
88
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- University of Alabama at Birmingham
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California
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Fullerton, California, Forente stater, 92835
- Regenerative Solutions
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Colorado
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Aurora, Colorado, Forente stater, 80012
- Drs. McClain and Schallhorn
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Michigan
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Ann Arbor, Michigan, Forente stater, 48106
- University of Michigan
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Texas
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Houston, Texas, Forente stater, 77063
- Perio Health Professionals
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San Antonio, Texas, Forente stater, 78229
- University of Texas Health Science Center at San Antonio
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
25 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: beta-tricalcium phosphate alone
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Eksperimentell: GFeBGS 0.1%
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
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Eksperimentell: GFeBGS 0.3%
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
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Eksperimentell: GFeGBS 0.4%
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
Tidsramme: 6 months post-surgery
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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.
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6 months post-surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Clinical Attachment Level at 3 Months
Tidsramme: Baseline and 3 months post-surgery
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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)
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Baseline and 3 months post-surgery
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Change in Clinical Attachment Level at 6 Months
Tidsramme: 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)
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Baseline and 6 months post-surgery
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Linear Bone Growth at 6 Months
Tidsramme: Baseline and 6 months post-surgery
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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)
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Baseline and 6 months post-surgery
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Percent Bone Fill at 6 Months
Tidsramme: Baseline and 6 months post-surgery
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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.
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Baseline and 6 months post-surgery
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Pocket Depth Change at 3 Months
Tidsramme: Baseline and 3 months post-surgery
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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)
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Baseline and 3 months post-surgery
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Pocket Depth Change at 6 Months
Tidsramme: Baseline and 6 months post-surgery
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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)
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Baseline and 6 months post-surgery
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Change in Gingival Recession at 3 Months
Tidsramme: Baseline and 3 months post-surgery
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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)
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Baseline and 3 months post-surgery
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Change in Gingival Recession at 6 Months
Tidsramme: Baseline and 6 months post-surgery
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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)
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Baseline and 6 months post-surgery
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: David L. Cochran, DDS, PhD, University of Texas Health Sciences Center at San Antonio
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2012
Primær fullføring (Faktiske)
1. august 2014
Studiet fullført (Faktiske)
1. august 2014
Datoer for studieregistrering
Først innsendt
1. november 2012
Først innsendt som oppfylte QC-kriteriene
16. november 2012
Først lagt ut (Anslag)
20. november 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. september 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. august 2020
Sist bekreftet
1. august 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CLP-2011-10-31-1
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