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Complementary Naturopathic Medicine for Periodontitis

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ClinicalTrials.gov Identifier: NCT00010634
Recruitment Status : Completed
First Posted : February 5, 2001
Last Update Posted : August 18, 2006
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

February 2, 2001
February 5, 2001
August 18, 2006
September 1999
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Complete list of historical versions of study NCT00010634 on ClinicalTrials.gov Archive Site
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Complementary Naturopathic Medicine for Periodontitis
Complementary Naturopathic Medicine for Periodontitis

This study aims to assess selected naturopathic medicines for adult periodontitis and to identify variables that influence successful outcomes when traditional and alternative approaches to preventing and treating periodontal diseases are combined. Collaboration between Kaiser Permanente, Oregon Health Science University and the National College of Naturopathic Medicine provides an unsurpassed environment for such investigations. Periodontitis is a major cause of tooth loss and negatively impacts systemic health. The limitations of traditional periodontal treatment have compelled scientists and clinicians to investigate new remedies, and naturopathic medicine holds several promising interventions.

Because they are used to improve elements of host resistance that are known to be important in periodontal health and disease, three naturopathic medicines are potential adjuncts in preventing and treating periodontitis. Connective tissue components are enzymatically degraded in periodontitis. In naturopathy, Connective Tissue Nutrient Formula (CTNF) (vitamins A, C and D, glucosamine sulfate, oligoproanthocyanindins, copper, zinc, manganese, boron, silicon, magnesium, and calcium) is prescribed specifically to enhance the integrity of key connective tissue elements and improve their resistance to degradation. Periodontitis begins when permeability of the oral sulcular epithelium permits pathogenic bacterial components to invade deeper periodontal connective tissues. In naturopathy, glutamine is prescribed to reduce oral-intestinal epithelial membrane permeability. Chronic activation of the hypothalamic-pituitary-adrenal (HPA) axis during the stress response, is a risk factor for periodontitis. Adaptogenic herbs (AH) (Panax ginseng, Withania somnifera and Eleutherococcus senticosus) are prescribed by naturopathic physicians to reverse the impact of bacterial and psychosocial stressors. Because glutamine, CTNF and AH target pathophysiologic mechanisms known to underline periodontitis, they are compelling candidates in clinical and mechanistic investigations of complementary medicine approaches to the management of periodontitis.

Kaiser Permanente adult periodontitis patients will serve as subjects and receive standard periodontal treatment. Three of the four randomly assigned groups will also receive supplements of glutamine, CTNF, or AH. We will determine the effects of these supplements on clinical outcomes (attachment loss, pocket depths, indicators of inflammation, plaque composition, need for periodontal surgery, acute periodontal problems, tooth loss). In addition to completing the battery of self-report measures (stress, coping, quality of life), study subjects will provide samples of blood, saliva, gingival cervicular fluid and bacterial dental plaque. These samples will be examined as part of the Laboratory Core to identify biologic and genetic characteristics that correlate with successful outcomes. Storage of portions of the samples will allow future examination of additional variables as part of the Developmental Projects carried out as the Craniofacial Complementary & Alternative Center is established and Phase III trials are undertaken.

See Brief Summary
Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Periodontitis
  • Drug: Connective Tissue Nutrient Formula
  • Drug: Adaptogenic herbs
  • Drug: glutamine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2004
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Inclusion Criteria:

  • Adult periodontitis
Sexes Eligible for Study: All
35 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00010634
P50AT000076-01P3( U.S. NIH Grant/Contract )
P50AT000076-01 ( U.S. NIH Grant/Contract )
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National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Theresa Madden Center for Health Research, Kaiser Foundation Hospitals
National Center for Complementary and Integrative Health (NCCIH)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP