The Importance of Periostin in Periodontal Health and Disease

Periodontal Disease Clinical Trial

Official title:

The Importance of Periostin in Periodontal Health and Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180920
• Other study ID #: HUM00038150
• Secondary ID: 5K23DE019872
• Status: Completed
• Phase: N/A
• First received: August 10, 2010
• Last updated: December 1, 2014
• Start date: June 2011
• Est. completion date: February 2013

Study information

• Verified date: December 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gingival Diseases
• Non-diseased Patients
• Periodontal Disease
• Periodontal Diseases

Locations

Country	Name	City	State
United States	Michigan Center for Oral Health Research	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (11)

Götz W, Heinen M, Lossdörfer S, Jäger 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: J Clin Periodontol. 2004 Feb;31(2):149. Chen, HW [corrected to Chen, HY]. — View Citation

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. — View Citation

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. — View Citation

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 . — View Citation

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. — View Citation

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. Epub 2003 May 22. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	explore the expression dynamics of Periostin during periodontal healing in healthy and diseased periodontia.	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.	8wks	No