Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01282229
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2011-01-13
Brief Title:
Study to Compare Laser Assisted New Attachment Procedure LANAP to Traditional Treatments of Chronic Periodontitis
Sponsor:
Institute for Advanced Laser Dentistry
Organization:
Institute for Advanced Laser Dentistry
Study Overview
Official Title:
A Multi-Center Single Blind Study of the Laser Assisted New Attachment Procedure Compared to Scaling and Root Planing Alone Modified Widman Flap Surgery and Coronal Debridement Alone in the Treatment of Chronic Periodontitis
Status:
COMPLETED
Status Verified Date:
2015-09
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:
LANAP
Brief Summary:
The purpose of this study is to compare the Laser Assisted New Attachment Procedure LANAP protocol using the Free-running FR Pulsed Neodimium Yttrium aluminium garnet NdYAG laser to Scaling and Root Planing SRP alone Modified Widman Flap MFF surgery and Coronal Debridement CD alone with respect to periodontal clinical attachment level gain
Detailed Description:
This multi-center study of the Laser Assisted New Attachment Procedure LANAP protocol using the FR Pulsed NdYAG laser compared to Scaling and Root Planing alone Modified Widman Flap MWF surgery and Coronal Debridement CD alone will utilize a single-blind four-quadrant split-mouth design with MWF as the positive control CD as a weak positive control and SRP as the standard treatment control The study will be conducted at three 3 to five 5 investigational centers Subjects will receive the Laser Assisted New Attachment Procedure LANAP protocol using the pulsed FR NdYAG laser Scaling and Root Planing alone Modified Widman Flap surgery and Coronal Debridement alone each in one quadrant of their mouth at Baseline Treatment modalities are randomly assigned to quadrants at the time of treatment
Efficacy evaluations including clinical attachment level CAL probing depth PD and bleeding on probing BOP will be performed at Baseline month 6 and month 12 using a Florida Electronic Probe Radiographs will be taken at ScreeningBaseline and at month 6 and month 12
Efficacy evaluations including clinical attachment level CAL probing depth PD and bleeding on probing BOP will be performed at Baseline month 6 and month 12 using a Florida Electronic Probe Radiographs will be taken at ScreeningBaseline and at month 6 and month 12
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