Clinical trial NCT06041828: Regular Home-use Dual Light Photodynamic Therapy in the Prevention of Osteolysis After Dental Implant Surgery
Official title: Impact of Regular Home-use Dual Light Photodynamic Therapy in the Prevention of Osteolysis After Dental Implant Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteolysis
Dental Implants
Keywords: Lumoral
Dental implant
Osteolysis
Anti-bacterial photodynamic therapy
Oral hygiene
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: Hammaslääkärit Eteläranta 10
name: University of Helsinki
First posted: 2023-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical study on a medical device.
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine whether regular use of the antibacterial, photodynamic, CE-marked Lumoral device reduces the risk of osteolysis after dental implant surgery. The study also aims to find out whether Lumoral treatment can replace the use of chlorhexidine. Subjects will be randomized into two groups (20 + 20 subjects) and all will be given individual guidance on maintaining good oral hygiene. The participants in the study group will also be given Lumoral appliances with instructions for use at home. The Lumoral device has been shown in previous studies to be safe to use and effective in eliminating harmful oral bacteria.

Detailed description: After a dental implant procedure, implant stability is crucial for the success of the implant. The initial stability of the implant is determined by various factors such as implant design, surgical technique, bone quality, and quantity.

During the implant procedure, the implant is placed into the jawbone and is in direct contact with the surrounding bone. Over time, the bone will grow and fuse with the implant surface in a process called osseointegration. The implant stability is evaluated immediately after the surgery by measuring the implant stability quotient (ISQ) using a device called an implant stability meter.

The ISQ value ranges from 0 to 100, with higher values indicating greater implant stability. In general, an ISQ value of 60 or higher is considered to be a good indicator of implant stability. If the initial ISQ value is low, the implant may be at risk of failure due to lack of stability, and additional measures may be necessary to promote osseointegration, such as using bone grafting materials or growth factors.

In the first few weeks after the implant procedure, the implant may experience some initial mobility due to the inflammatory response and remodeling of the bone around the implant. However, with time, the bone will grow and fuse with the implant, providing a stable foundation for dental restoration.

With proper implant placement and regular follow-up care, the incidence of osteolysis can be minimized. Maintaining good oral hygiene practices, such as regular brushing, flossing, and dental check-ups, can help reduce the risk of inflammatory changes around dental implants. In addition, patients are usually advised to avoid placing excessive force on the implant during the healing process to prevent any damage to the implant and to ensure successful osseointegration. For example, patients can be advised to have a soft food diet at least for a few days after the implant placement.

One of the key issues in maintaining good oral health is patient self-management. A new tool "Lumoral Treatment" has been introduced in order to enhance oral home care. The Lumoral Treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on the dental plaque in a home environment. It is used together with the mechanical cleaning (such as toothbrushing) of teeth. The device mechanism of action is antibacterial photodynamic therapy (aPDT) and thus non-medicinal. The Lumoral Treatment includes a light-activated Lumorinse mouth rinse and a Lumoral light activator. Its effect is based on a photodynamic method where the light-sensitive substance - indocyanine green - contained in the Lumorinse mouth rinse is attached to the bacterial film (plaque) and is activated by antibacterial dual light with 405 and 810 nanometers (nm).

The 810 nm light can also have a photobiomodulation effect in promoting bone growth and regeneration. Photobiomodulation (PBM) is a non-invasive therapy that uses low-level light therapy (LLLT) to stimulate cellular function and enhance tissue repair. Near-infrared (NIR) light is one of the commonly used wavelengths for PBM due to its ability to penetrate deeper into tissues. In the case of dental bone, PBM with NIR light has shown promising effects in promoting bone growth and regeneration. In dental applications, PBM with NIR light has shown promise in promoting bone growth and regeneration in cases of dental implant placement, tooth extraction, and periodontal disease.

Eligibility criteria: Inclusion Criteria:

* Age of ≥ 18 years
* Generally healthy,
* At least one new implant inserted
* New implant inserted
* Agreement to participate in the study with a written consent form signed

Exclusion Criteria:

* Uncontrolled diabetes mellitus (DM)
* Active smoking
* Any significant systemic disease
* Immediate implantation after tooth extraction
* Use of antibiotics within 4 weeks week prior study
* Presence of any physical limitation or restriction that might restrict Lumoral use
* Pregnancy or lactation
* History of six months use of antimicrobials, bisphosphonates, or corticosteroids.

Primary outcomes:
measure: Incidence of osteolysis around dental implants
timeFrame: 4 months
Secondary outcomes:
measure: Active matrix metalloproteinase 8 (aMMP-8)
timeFrame: 4 months
measure: Bleeding on probing (BOP)
timeFrame: 4 months
measure: Probing Pocket Depth (PPD)
timeFrame: 4 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Hammaslääkärit Eteläranta 10
state: Uusimaa
Study officials:
affiliation: University of Helsinki
name: Timo Sorsa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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