Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296881
Status:
UNKNOWN
Last Update Posted:
2007-05-21
First Post:
2006-02-23
Brief Title:
SRP in Combination With PERIOWAVE in Comparison to SRP Alone in Chronic Periodontitis
Sponsor:
Ondine Research Laboratories
Organization:
Ondine Research Laboratories
Study Overview
Official Title:
Clinical Outcomes Following Non-Surgical Treatment of Chronic Periodontitis Using Scaling and Root Planing SRP in Conjunction With PerioWave Compared to SRP Alone
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 is to determine whether scaling and root planning SRP followed by photodynamic disinfection results in improved outcomes that persist over time in adults with chronic periodontitis when compared with subjects with SRP alone
Detailed Description:
Extensive research has shown that lethal photosensitization with low levels of laser light is an effective method of killing numerous types of organisms This therapy avoids the use of antibiotics along with their potential side effects The initial application of this therapy to the oral cavity is particularly appropriate since the therapy can be applied topically either in a specific or general fashion killing is immediate and resistance is unlikely as it is free radical-mediated In addition the disease states being treated gingivitis periodontitis are highly prevalent and associated with significant morbidity The equipment and costs of this therapy are simple easily applied and relatively inexpensive compared with current therapies Based on the scientific data to date this therapy has the potential of significantly improving the oral health of those affected
This is a pivotal prospective randomized examiner blinded multicenter study to evaluate the effect of a single treatment of photodynamic disinfection in adults with chronic periodontal disease
This is a pivotal prospective randomized examiner blinded multicenter study to evaluate the effect of a single treatment of photodynamic disinfection in adults with chronic periodontal disease
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