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.

Regular Home-use Dual Light Photodynamic Therapy in the Prevention of Osteolysis After Dental Implant Surgery

Osteolysis

Dental Implants

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.

Lumoral Treatment

Standard oral hygiene

Impact of Regular Home-use Dual Light Photodynamic Therapy in the Prevention of Osteolysis After Dental Implant Surgery

Assessing overall number of study subject that have developed osteolysis

Change in periodontal inflammation marker aMMP-8. The aMMP-8 marker analysis will be performed using Periosafe chairside test (Dentognostics GmbH) according to the manufacturer's instructions.

Change in bleeding on probing (BOP)
A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent" BOP is reported as the percentage (%) of sites with positive findings Calculation formula: number of bleeding sites/ 6 times number of teeth

Change in the Probing Pocket Depth (PPD)
A full-mouth assessment, measured at 4 sites per tooth Assessed from the base of the pocket to the gingival margin (mm)

Standard oral hygiene and Lumoral Treatment home-use

Regular Home-use Dual Light Photodynamic Therapy in the Prevention of Osteolysis After Dental Implant Surgery

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status