Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010634
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2001-02-02
Brief Title:
Complementary Naturopathic Medicine for Periodontitis
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Complementary Naturopathic Medicine for Periodontitis
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
See Brief Summary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50AT000076-01 | NIH | None | httpsreporternihgovquickSearchP50AT000076-01 |