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Periodontal DiseaseNCT01180920

The Importance of Periostin in Periodontal Health and Disease

An observational study of Periodontal Disease and Non-diseased Patients, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Periodontal Disease, Non-diseased Patients
How many people
22 participants
Where
1 siteUnited States
Study dates
Jun 2011to Feb 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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
  • Subjects requiring a gingivectomy or crown lengthening procedure

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Michigan Center for Oral Health Research

    Ann Arbor, Michigan, 48106

Other trials in United States

About this study

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.

Read the 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.

Keywords
Dental, Periodontal, Surgery, Gums
Medical subject headings
Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01180920
Study groupRoleWhat they receive
Periodontal disease11 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 periodontium11 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Secondary outcomes (1)

  1. 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.

    Measured: 8wks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2010 (estimated)
  2. Study startJun 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01180920
Sponsor's protocol ID
HUM00038150
Other IDs
5K23DE019872
Status last verified
Dec 2014
First submitted
10 Aug 2010
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15142215

  • 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.

    PubMed 15491460

  • 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.

    PubMed 16321360

  • 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.

    PubMed 15316471

  • 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.

    PubMed 16146769

  • 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.

    PubMed 18672999

  • 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.

    PubMed 18642132

  • 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.

    PubMed 10404027

  • 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.

    PubMed 12761672

  • 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.

    PubMed 11940142

  • 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.

    PubMed 15152815

  • 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.

    PubMed 22933606

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Disease and Non-diseased Patients, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01180920, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.

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