The Importance of Periostin in Periodontal Health and Disease

NCT01180920 | Completed

• 2 other identifiers: HUM000381505K23DE019872
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Disease; Non-diseased Patients

Keywords

Dental; Periodontal; Surgery; Gums

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline

Secondary Outcomes (1)

• explore the expression dynamics of Periostin during periodontal healing in healthy and diseased periodontia.

  8wks

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will have a sample size of 22 subjects: 11 periodontally healthy and 11 with periodontal disease.

You may qualify if:

• Diagnosis of generalized chronic or aggressive periodontitis
• Need an open flap procedure
• Subjects requiring a gingivectomy or crown lengthening procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (12)

• 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.

  PMID: 15142215 BACKGROUND

• 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.

  PMID: 15491460 BACKGROUND

• 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.

  PMID: 16321360 BACKGROUND

• 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.

  PMID: 15316471 BACKGROUND

• 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.

  PMID: 16146769 BACKGROUND

• 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.

  PMID: 18672999 BACKGROUND

• 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.

  PMID: 18642132 BACKGROUND

• 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.

  PMID: 10404027 BACKGROUND

• 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.

  PMID: 12761672 BACKGROUND

• 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.

  PMID: 11940142 BACKGROUND

• 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.

  PMID: 15152815 BACKGROUND

• 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.

  PMID: 22933606 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Each patient will be have 5ml of blood collected at 3 different visits. Saliva, and gingival crevicular fluid will also be collected at 7-8 visits during the study. Gingival tissue will be collected on the day of surgery.

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Hector Rios, MS, DDS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• William V Giannobile, DDS, DMSc

  University of Michigan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Periodontal and Oral Medicine

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 12, 2010
• Study Start: June 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)