Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391547
Status:
COMPLETED
Last Update Posted:
2007-10-22
First Post:
2006-10-20
Brief Title:
Pilot Efficacy Study to Treat Gingivitis
Sponsor:
Biomedical Development Corporation
Organization:
Biomedical Development Corporation
Study Overview
Official Title:
Phase II Pilot Efficacy Study to Treat Gingivitis
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose is to demonstrate the efficacy of a prescription mouthrinse in human subjects for treatment of Gingivitis
Detailed Description:
Gingivitis is an endemic disease that is a precursor to periodontal disease Two mouthrinse agents Peridex and Listerine have received the Seal of Acceptance from the Council on Dental Therapeutics of the American Dental Association for the control of supragingival plaque and gingivitis Peridex 012 chlorhexidine bisbiguanide cationic detergent is a prescription mouthrinse that demonstrates potent anti-plaque and anti-gingivitis action Chlorhexidine rinses are also prescribed to prevent post surgical infections Chlorhexidine has broad spectrum antibacterial activity and substantivity With prolonged use chlorhexidine maintains its effectiveness but causes staining of natural teeth and composite materials used in restorative dentistry Other side effects associated with chlorhexidine are calculus formation and possible alterations in taste Although chlorhexidine rinses and supragingival irrigations have demonstrated significant efficacy in reducing plaque and gingivitis chlorhexidine has had a minimal impact in treating periodontal disease Listerine comprised of essential oils is an over-the-counter mouthrinse that is less effective than chlorhexidine in controlling plaque and gingivitis but has minimal side effects Other agents such as quaternary ammonium compounds and metal salts are rarely used alone but can be used in combination with other antimicrobial rinses to enhance their effectiveness
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 |
|---|---|---|---|
| NIH Grant No 9R44NR009015-02 | None | None | None |