The Importance of Periostin in Periodontal Health and Disease
1. december 2014 opdateret af: Hector Rios, University of Michigan
The goal of this study is to determine the clinical importance of Periostin in oral health and disease.
The long-term goal will be to develop practical applications for the diagnosis, treatment, prevention and cure of human periodontal diseases.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
It is hypothesized that Periostin levels are decreased during periodontal diseases, thereby, elevating the hosts' susceptibility to periodontal breakdown.
The specific aims are the following; To determine if Periostin is a biomarker of periodontal disease, and To evaluate Periostin in periodontal tissue healing and homeostasis by harvesting healthy or diseased tissue from 22 patients requiring periodontal surgery.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
22
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106
- Michigan Center for Oral Health Research
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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
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
This study will have a sample size of 22 subjects: 11 periodontally healthy and 11 with periodontal disease.
Beskrivelse
Inclusion Criteria:
Inclusion criteria for diseased subjects:
- Diagnosis of generalized chronic or aggressive periodontitis
- At least four periodontal sites with probing depth (PD) ≥6 mm, evidence of clinical attachment loss (CAL), and bleeding on probing (BOP). Inclusion criteria for healthy individuals will include PD <4 mm, no evidence of attachment loss, and <10% of sites with BOP
- Need an open flap procedure
Inclusion criteria for non-diseased subjects:
- Subjects requiring a gingivectomy or crown lengthening procedure
Exclusion Criteria:
- History of alcoholism or drug abuse
- Medical conditions that may affect the outcome such as autoimmune diseases, diabetes, immunocompromised subjects, neurologic or psychiatric disorders, systemic infections, etc.
- Chronic medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications, Depo-Provera contraceptive injection users, new oral contraceptives users within 3 months of baseline or subjects that are planning on, starting oral contraceptives during the study.
- Antibiotic therapy within 3 months of the baseline visit, and/or antibiotic therapy needed for infective endocarditis prophylaxis.
- Current use or quit smoking less than one year ago with a pack-year history of more than or equal to 10.
- Untreated cavities
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Periodontal disease
11 patients with periodontal disease, specifically generalized chronic or aggressive periodontitis will be selected.
In general, the disease group will be comprised of subjects that need an open flap procedure.
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Healthy periodontium
11 patients without periodontal disease will be selected.
In general, the healthy group will be comprised of subjects that are requiring a gingivectomy or crown lengthening procedure.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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To determine whether the expression of Periostin within the periodontal tissues is affected in periodontal disease progression in-vivo and whether Periostin levels are associated with disease susceptibility.
Tidsramme: Baseline
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Periostin levels from gingival crevicular fluid (GCF), saliva, serum and tissue will be analyzed in both health and disease.
Total RNA and protein extracts will be isolated and utilized for relative quantitative measurements.
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Baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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explore the expression dynamics of Periostin during periodontal healing in healthy and diseased periodontia.
Tidsramme: 8wks
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A longitudinal study will also be performed to evaluate Periostin levels in GCF/wound fluids and saliva over time during periodontal tissue healing and homeostasis.
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8wks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Hector Rios, MS, DDS, University of Michigan
- Studieleder: William V Giannobile, DDS, DMSc, University of Michigan
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
- Needleman I, McGrath C, Floyd P, Biddle A. Impact of oral health on the life quality of periodontal patients. J Clin Periodontol. 2004 Jun;31(6):454-7. doi: 10.1111/j.1600-051X.2004.00498.x.
- Socransky SS, Haffajee AD, Smith C, Martin L, Haffajee JA, Uzel NG, Goodson JM. Use of checkerboard DNA-DNA hybridization to study complex microbial ecosystems. Oral Microbiol Immunol. 2004 Dec;19(6):352-62. doi: 10.1111/j.1399-302x.2004.00168.x.
- Gotz W, Heinen M, Lossdorfer S, Jager A. Immunohistochemical localization of components of the insulin-like growth factor system in human permanent teeth. Arch Oral Biol. 2006 May;51(5):387-95. doi: 10.1016/j.archoralbio.2005.10.005.
- Lee A, Schneider G, Finkelstein M, Southard T. Root resorption: the possible role of extracellular matrix proteins. Am J Orthod Dentofacial Orthop. 2004 Aug;126(2):173-7. doi: 10.1016/j.ajodo.2004.02.009.
- Yang YQ, Li XT, Rabie AB, Fu MK, Zhang D. Human periodontal ligament cells express osteoblastic phenotypes under intermittent force loading in vitro. Front Biosci. 2006 Jan 1;11:776-81. doi: 10.2741/1835.
- Rios HF, Ma D, Xie Y, Giannobile WV, Bonewald LF, Conway SJ, Feng JQ. Periostin is essential for the integrity and function of the periodontal ligament during occlusal loading in mice. J Periodontol. 2008 Aug;79(8):1480-90. doi: 10.1902/jop.2008.070624.
- Hamilton DW. Functional role of periostin in development and wound repair: implications for connective tissue disease. J Cell Commun Signal. 2008 Jun;2(1-2):9-17. doi: 10.1007/s12079-008-0023-5. Epub 2008 Jul 20.
- Horiuchi K, Amizuka N, Takeshita S, Takamatsu H, Katsuura M, Ozawa H, Toyama Y, Bonewald LF, Kudo A. Identification and characterization of a novel protein, periostin, with restricted expression to periosteum and periodontal ligament and increased expression by transforming growth factor beta. J Bone Miner Res. 1999 Jul;14(7):1239-49. doi: 10.1359/jbmr.1999.14.7.1239.
- Wilde J, Yokozeki M, Terai K, Kudo A, Moriyama K. The divergent expression of periostin mRNA in the periodontal ligament during experimental tooth movement. Cell Tissue Res. 2003 Jun;312(3):345-51. doi: 10.1007/s00441-002-0664-2. Epub 2003 May 22.
- Kiili M, Cox SW, Chen HY, Wahlgren J, Maisi P, Eley BM, Salo T, Sorsa T. Collagenase-2 (MMP-8) and collagenase-3 (MMP-13) in adult periodontitis: molecular forms and levels in gingival crevicular fluid and immunolocalisation in gingival tissue. J Clin Periodontol. 2002 Mar;29(3):224-32. doi: 10.1034/j.1600-051x.2002.290308.x. Erratum In: J Clin Periodontol. 2004 Feb;31(2):149. Chen, HW [corrected to Chen, HY].
- Jee SW, Wang S, Kapila YL. Specific pro-apoptotic fibronectin fragments modulate proteinase expression in periodontal ligament cells. J Periodontol. 2004 Apr;75(4):523-30. doi: 10.1902/jop.2004.75.4.523.
- Padial-Molina M, Volk SL, Taut AD, Giannobile WV, Rios HF. Periostin is down-regulated during periodontal inflammation. J Dent Res. 2012 Nov;91(11):1078-84. doi: 10.1177/0022034512459655. Epub 2012 Aug 29.
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. juni 2011
Primær færdiggørelse (Faktiske)
1. februar 2013
Studieafslutning (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først indsendt
10. august 2010
Først indsendt, der opfyldte QC-kriterier
11. august 2010
Først opslået (Skøn)
12. august 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HUM00038150
- 5K23DE019872 (U.S. NIH-bevilling/kontrakt)
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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