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

27. august 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

88

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: beta-tricalcium phosphate alone
Enhed: beta-tricalcium phosphate alone
Eksperimentel: GFeBGS 0.1%
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
Enhed: GFeBGS 0.1%
Eksperimentel: GFeBGS 0.3%
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
Enhed: GFeBGS 0.3%
Eksperimentel: GFeGBS 0.4%
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
Enhed: GFeBGS 0.4%

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Clinical Attachment Level at 3 Months
Tidsramme: 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
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)
Baseline and 6 months post-surgery
Linear Bone Growth at 6 Months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sunstar Americas

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

1. november 2012

Først indsendt, der opfyldte QC-kriterier

16. november 2012

Først opslået (Skøn)

20. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2020

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLP-2011-10-31-1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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