Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656325
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Evaluation of the Effect of the Erchonia Corporation FX-405 Laser as an Adjunctive Treatment of Periodontitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
R-GUM
Brief Summary:
The purpose of this clinical study is to determine the effectiveness of the Erchonia FX-405 manufactured by Erchonia Corporation the Company in providing a noninvasive adjunctive treatment in combination with periodontal scaling and root planing for improving the treatment of periodontal disease
Detailed Description:
The purpose of this clinical study is to determine the effectiveness of the Erchonia FX-405 manufactured by Erchonia Corporation the Company in providing a noninvasive adjunctive treatment in combination with periodontal scaling and root planing for improving the treatment of periodontal disease This clinical study is a double-blind design such that neither the subject nor the investigators - the investigator administering the treatment with the Erchonia FX-405 device administration investigator or the investigator recording the outcome measures assessment investigator - will be aware of whether the subject has been assigned to the active treatment test group or to the sham treatment control group until after the study is complete All study subjects regardless of treatment group assignment will receive active scaling and root planing SRP standard of care therapy in addition to the active or sham therapy with the Erchonia FX-405 device
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