Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
Study NCT ID:
NCT06859866
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2025-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis
Sponsor:
Koite Health Oy
Organization:
Study Overview
Official Title:
Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis: A Post-Marketing Interventional Pilot Study With a Medical Device
Status:
RECRUITING
Status Verified Date:
2025-08
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:
None
Brief Summary:
The study aims to establish a validated protocol enabling an alternative approach for bacterial biofilm control through the application of a novel at-home photodynamic/antibacterial blue light therapy in addition to non-surgical professional treatment (NST) for peri-implant mucositis. The primary outcomes will include reductions in plaque and bleeding scores, decreases in probing pocket depth, and lower aMMP-8 levels in PISF. Secondary outcomes will include changes in keratinized peri-implant mucosa (KPIM) and patient-reported outcome measures (PROMs).
Detailed Description:
Dental implants offer an opportunity to restore oral health by replacing missing teeth, demonstrating exceptional longevity when properly maintained. The maintenance of implant health primarily depends on the effective removal of dental plaque, which is the primary cause of periodontal diseases, from both dental and prosthetic surfaces.
According to an accepted definition, peri-implant mucositis is an inflammation of the peri-implant mucosa without loss of supporting bone tissue, while peri-implantitis is characterized by inflammation of the peri-implant mucosa associated with supporting bone loss. Recent data indicate that a significant proportion, ranging from 50% to 90%, of implants are affected by peri-implant mucositis.
The diagnosis of peri-implant mucositis is currently based on clinical observations; however, clinical evaluations may yield false positives or fail to allow early diagnosis and timely treatment of pathological conditions. With the knowledge of the current restrictions, this study aims to evaluate the levels of active matrix metalloproteinase-8 (aMMP-8) derived from Peri-Implant Sulcular Fluid (PISF), which is one of the most precise and sensitive diagnostic markers of peri-implant tissue inflammation.
The treatment of peri-implant mucositis currently encompasses a range of professional and at-home measures. Typically, peri-implant mucositis precedes the characteristic bone loss of peri-implantitis; therefore, the timely treatment of clinical signs of inflammation is critical to prevent disease progression that could culminate in implant failure. Inadequate plaque removal increases the risk of peri-implantitis by hindering access to implant sites for oral hygiene, resulting in a higher incidence in areas that patients are unable to clean effectively compared to easily accessible sites, underscoring the importance of focusing on at-home dental care.
New methods for at-home oral care are under development, such as antimicrobial photodynamic therapy (aPDT), which utilizes a photosensitizer (PS) and low-intensity visible light to generate reactive oxygen species (ROS) that target pathogenic bacteria. Antibacterial blue light takes advantage of the intrinsic antimicrobial properties derived from endogenous photosensitizing chromophores of pathogenic microbes, eliminating the need for exogenous dyes.
According to an accepted definition, peri-implant mucositis is an inflammation of the peri-implant mucosa without loss of supporting bone tissue, while peri-implantitis is characterized by inflammation of the peri-implant mucosa associated with supporting bone loss. Recent data indicate that a significant proportion, ranging from 50% to 90%, of implants are affected by peri-implant mucositis.
The diagnosis of peri-implant mucositis is currently based on clinical observations; however, clinical evaluations may yield false positives or fail to allow early diagnosis and timely treatment of pathological conditions. With the knowledge of the current restrictions, this study aims to evaluate the levels of active matrix metalloproteinase-8 (aMMP-8) derived from Peri-Implant Sulcular Fluid (PISF), which is one of the most precise and sensitive diagnostic markers of peri-implant tissue inflammation.
The treatment of peri-implant mucositis currently encompasses a range of professional and at-home measures. Typically, peri-implant mucositis precedes the characteristic bone loss of peri-implantitis; therefore, the timely treatment of clinical signs of inflammation is critical to prevent disease progression that could culminate in implant failure. Inadequate plaque removal increases the risk of peri-implantitis by hindering access to implant sites for oral hygiene, resulting in a higher incidence in areas that patients are unable to clean effectively compared to easily accessible sites, underscoring the importance of focusing on at-home dental care.
New methods for at-home oral care are under development, such as antimicrobial photodynamic therapy (aPDT), which utilizes a photosensitizer (PS) and low-intensity visible light to generate reactive oxygen species (ROS) that target pathogenic bacteria. Antibacterial blue light takes advantage of the intrinsic antimicrobial properties derived from endogenous photosensitizing chromophores of pathogenic microbes, eliminating the need for exogenous dyes.
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?: