Periodontitis Clinical Trial
Official title:
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 ;
Allocation: Randomized, Primary Purpose: Treatment
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