GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
27 agosto 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
88
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- University of Alabama at Birmingham
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California
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Fullerton, California, Stati Uniti, 92835
- Regenerative Solutions
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Colorado
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Aurora, Colorado, Stati Uniti, 80012
- Drs. McClain and Schallhorn
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48106
- University of Michigan
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Texas
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Houston, Texas, Stati Uniti, 77063
- Perio Health Professionals
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San Antonio, Texas, Stati Uniti, 78229
- University of Texas Health Science Center at San Antonio
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
25 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: beta-tricalcium phosphate alone
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Sperimentale: GFeBGS 0.1%
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
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Sperimentale: GFeBGS 0.3%
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
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Sperimentale: GFeGBS 0.4%
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Clinical Attachment Level at 3 Months
Lasso di tempo: 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
Lasso di tempo: Baseline and 6 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 = (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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: David L. Cochran, DDS, PhD, University of Texas Health Sciences Center at San Antonio
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2012
Completamento primario (Effettivo)
1 agosto 2014
Completamento dello studio (Effettivo)
1 agosto 2014
Date di iscrizione allo studio
Primo inviato
1 novembre 2012
Primo inviato che soddisfa i criteri di controllo qualità
16 novembre 2012
Primo Inserito (Stima)
20 novembre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 settembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 agosto 2020
Ultimo verificato
1 agosto 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CLP-2011-10-31-1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .