Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 8:19 PM
Study NCT ID:
NCT03624257
Status:
WITHDRAWN
Last Update Posted:
2019-07-15
First Post:
2018-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery
Sponsor:
Sirona Dental Systems GmbH
Organization:
Study Overview
Official Title:
Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery
Status:
WITHDRAWN
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision: priority change (Study approved by ethics committee and Swedish competent authority)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A clinical trial comparing laser treatment and conventional mucosal flap surgery for treatment of peri-implantitis. The main aim of the study is to evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.
Detailed Description:
The present project aims to evaluate a novel method in treating peri-implantitis, with focus on decreasing the patient's suffering as well as disease progression. Peri-implantitis has a direct influence on both physical and psychological well-being and have been related to difficulty in chewing due to loss of implants, bad esthetic appearance as well as high costs. Therefore, it is of importance for the individual as well as for the society to thoroughly investigate any new treatment approaches.
The study is a prospective randomized clinical trial comparing laser treatment (test group) and conventional mucosal flap surgery (active control group). Assessment of clinical variables at baseline and after 6 months. Patient reported outcomes at baseline, directly after treatment and after 10 days.
Primary Objective:
To evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.
Secondary Objectives:
* To evaluate other clinical and radiological variables connected to peri-implantitis and the inflammation surrounding the dental implant.
* To evaluate the patient experience of a novel blue laser for treatment of peri-implantitis.
* To evaluate the inflammatory and microbial response after laser treatment
The study is a prospective randomized clinical trial comparing laser treatment (test group) and conventional mucosal flap surgery (active control group). Assessment of clinical variables at baseline and after 6 months. Patient reported outcomes at baseline, directly after treatment and after 10 days.
Primary Objective:
To evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.
Secondary Objectives:
* To evaluate other clinical and radiological variables connected to peri-implantitis and the inflammation surrounding the dental implant.
* To evaluate the patient experience of a novel blue laser for treatment of peri-implantitis.
* To evaluate the inflammatory and microbial response after laser treatment
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CIV-1 8-06-024304 | OTHER | EUDAMED | View |