Complementary Naturopathic Medicine for Periodontitis
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ToestandVoltooid
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
KLINISCHE PROEF: NCT00010634
BioSeek: nct00010634
Sleutelwoorden
Abstract
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.
Omschrijving
See Brief Summary
Datums
Laatst geverifieerd: | 07/31/2006 |
Eerste ingediend: | 02/01/2001 |
Geschatte inschrijving ingediend: | 02/01/2001 |
Eerst geplaatst: | 02/04/2001 |
Laatste update ingediend: | 08/16/2006 |
Laatste update geplaatst: | 08/17/2006 |
Werkelijke startdatum van het onderzoek: | 08/31/1999 |
Geschatte voltooiingsdatum van het onderzoek: | 06/30/2004 |
Conditie of ziekte
Periodontitis
Interventie / behandeling
Drug: Connective Tissue Nutrient Formula
Drug: Adaptogenic herbs
Drug: glutamine
Fase
Fase 2
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie | 35 Years Naar 35 Years |
Geslachten die in aanmerking komen voor studie | All |
Accepteert gezonde vrijwilligers | Ja |
Criteria | Inclusion Criteria: - Adult periodontitis |