Clinical trial NCT01180920: The Importance of Periostin in Periodontal Health and Disease
Official title: The Importance of Periostin in Periodontal Health and Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Disease
Non-diseased Patients
Keywords: Dental
Periodontal
Surgery
Gums
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2010-08-12
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Baseline
Secondary outcomes:
measure: explore the expression dynamics of Periostin during periodontal healing in healthy and diseased periodontia.
timeFrame: 8wks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Center for Oral Health Research
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hector Rios, MS, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: William V Giannobile, DDS, DMSc
role: STUDY_DIRECTOR
References:
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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. doi: 10.2741/1835.
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.
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.
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. doi: 10.1359/jbmr.1999.14.7.1239.
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. doi: 10.1007/s00441-002-0664-2. Epub 2003 May 22.
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. doi: 10.1034/j.1600-051x.2002.290308.x.
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. doi: 10.1902/jop.2004.75.4.523.
citation: 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.