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

March 5, 2024 updated by: Koite Health Oy

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00130
        • Hammaslääkärit Eteläranta 10
        • Contact:
        • Sub-Investigator:
          • Timo Stranden, DDS
        • Sub-Investigator:
          • Pekka Kallio, Docent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Standard oral hygiene and Lumoral Treatment home-use
Device: Lumoral Treatment
Photodynamic antibacterial dual-light device with a marker substance
Other: Standard oral hygiene
Standard oral hygiene instructions
Active Comparator: Control group
Standard oral hygiene only
Other: Standard oral hygiene
Standard oral hygiene instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of osteolysis around dental implants
Time Frame: 4 months
Assessing overall number of study subject that have developed osteolysis
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active matrix metalloproteinase 8 (aMMP-8)
Time Frame: 4 months
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.
4 months
Bleeding on probing (BOP)
Time Frame: 4 months

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
4 months
Probing Pocket Depth (PPD)
Time Frame: 4 months

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)
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koite Health Oy

Collaborators

University of Helsinki
Hammaslääkärit Eteläranta 10

Investigators

  • Principal Investigator: Timo Sorsa, Professor, University of Helsinki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 2, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LumOsteo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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