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

27 augustus 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

88

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

25 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: beta-tricalcium phosphate alone
Apparaat: beta-tricalcium phosphate alone
Experimenteel: GFeBGS 0.1%
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
Apparaat: GFeBGS 0.1%
Experimenteel: GFeBGS 0.3%
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
Apparaat: GFeBGS 0.3%
Experimenteel: GFeGBS 0.4%
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
Apparaat: GFeBGS 0.4%

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
Tijdsspanne: 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.
6 months post-surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Clinical Attachment Level at 3 Months
Tijdsspanne: Baseline and 3 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 = (3 months measurement - Baseline measurement)
Baseline and 3 months post-surgery
Change in Clinical Attachment Level at 6 Months
Tijdsspanne: 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)
Baseline and 6 months post-surgery
Linear Bone Growth at 6 Months
Tijdsspanne: Baseline and 6 months post-surgery
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
Tijdsspanne: Baseline and 6 months post-surgery
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
Tijdsspanne: Baseline and 3 months post-surgery
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
Tijdsspanne: Baseline and 6 months post-surgery
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
Tijdsspanne: Baseline and 3 months post-surgery
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
Tijdsspanne: Baseline and 6 months post-surgery
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sunstar Americas

Onderzoekers

  • Hoofdonderzoeker: David L. Cochran, DDS, PhD, University of Texas Health Sciences Center at San Antonio

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2012

Primaire voltooiing (Werkelijk)

1 augustus 2014

Studie voltooiing (Werkelijk)

1 augustus 2014

Studieregistratiedata

Eerst ingediend

1 november 2012

Eerst ingediend dat voldeed aan de QC-criteria

16 november 2012

Eerst geplaatst (Schatting)

20 november 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2020

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2020

Laatst geverifieerd

1 augustus 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CLP-2011-10-31-1

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