Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT03383120
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2017-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diode Laser for Treatment of Peri-implantitis
Sponsor:
University of Geneva, Switzerland
Organization:
Study Overview
Official Title:
A Randomized Controlled Clinical Trial Comparing Surgical Treatment of Peri-implantitis and Non-surgical Debridement With Adjunctive Diode Laser Therapy
Status:
COMPLETED
Status Verified Date:
2021-05
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:
LAS
Brief Summary:
The primary objective is to evaluate the clinical and patient-centered outcomes of non-surgical mechanical debridement with adjunctive repeated diode laser application (test) in comparison with conventional surgical treatment and adjunctive systemic antibiotics (control), for treatment of peri-implantitis lesions, following an observation period of one year.
Detailed Description:
Peri-implantitis is a major complication for dental implant patients, with its prevalence estimated in the order of 10% of implants and 20% of patients after 5 to 10 years of implant placement. When left untreated, peri-implantitis may cause progressive tissue destruction, esthetic complications and, eventually, implant loss. Despite numerous clinical trials and systematic reviews, studies have failed to identify a standardized protocol for the treatment of such conditions. Still, current literature and expert opinions recommend mechanical debridement of the implant followed by early evaluation and surgical intervention, implant decontamination using a wide variety of mechanical and chemical methods, then adjunctive systematic antibiotics. However, given the aggressive nature of surgical interventions, the inherent difficulty of decontaminating the implants' rough surfaces with conventional methods, in addition to the growing concerns over antibiotic resistance, the search for alternative approaches has become imperative. Since implant decontamination is the key aspect to resolution of peri-implantitis, different mechanical and chemical methods have been tested in that respect. In recent years, lasers have been attracting significant attention in this particular field. Diode lasers, in particular, have been shown to have potent bactericidal and photobiomodulatory effects promoting wound healing and tissue regeneration. Therefore, the aim of this randomized controlled clinical trial is to evaluate the clinical and patient-centered outcomes of non-surgical debridement with adjunctive repeated diode laser application in comparison with conventional surgical treatment with adjunctive systemic antibiotics for treatment of peri-implantitis lesions following an observation period of one year.
The primary objective is to evaluate the clinical and patient-centered outcomes of non-surgical mechanical debridement with adjunctive repeated diode laser application (test) in comparison with conventional surgical treatment and adjunctive systemic antibiotics (control), for treatment of peri-implantitis lesions, following an observation period of one year.
40 subjects will be randomly distributed into two parallel groups:
1. Test group (n= 20); receiving non-surgical mechanical debridement and adjunctive diode laser application at days 0, 7 and 14.
2. Control group (n= 20); receiving initial mechanical debridement at day 0, followed by open flap debridement and prescription of post-operative systemic antimicrobials at day 14.
The primary objective is to evaluate the clinical and patient-centered outcomes of non-surgical mechanical debridement with adjunctive repeated diode laser application (test) in comparison with conventional surgical treatment and adjunctive systemic antibiotics (control), for treatment of peri-implantitis lesions, following an observation period of one year.
40 subjects will be randomly distributed into two parallel groups:
1. Test group (n= 20); receiving non-surgical mechanical debridement and adjunctive diode laser application at days 0, 7 and 14.
2. Control group (n= 20); receiving initial mechanical debridement at day 0, followed by open flap debridement and prescription of post-operative systemic antimicrobials at day 14.
Study Oversight
Has Oversight DMC:
True
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?: