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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06041828
• Other study ID #: LumOsteo
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Koite Health Oy
• Contact: Mikko Kylmänen
• Phone: 0407245934
• Email: mikko.kylmanen[@]koitehealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implants
• Osteolysis

Intervention

Device:
• Lumoral Treatment
Photodynamic antibacterial dual-light device with a marker substance

Other:
• Standard oral hygiene
Standard oral hygiene instructions

Locations

Country	Name	City	State
Finland	Hammaslääkärit Eteläranta 10	Helsinki	Uusimaa

Sponsors (3)

Lead Sponsor	Collaborator
Koite Health Oy	Hammaslääkärit Eteläranta 10, University of Helsinki

Country where clinical trial is conducted

Finland, 

References & Publications (8)

Dompe C, Moncrieff L, Matys J, Grzech-Lesniak K, Kocherova I, Bryja A, Bruska M, Dominiak M, Mozdziak P, Skiba THI, Shibli JA, Angelova Volponi A, Kempisty B, Dyszkiewicz-Konwinska M. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724. doi: 10.3390/jcm9061724. — View Citation

Gupta R, Gupta N, Weber, DDS KK. Dental Implants. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470448/ — View Citation

H H, G W, E H. The clinical significance of implant stability quotient (ISQ) measurements: A literature review. J Oral Biol Craniofac Res. 2020 Oct-Dec;10(4):629-638. doi: 10.1016/j.jobcr.2020.07.004. Epub 2020 Aug 14. — View Citation

Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052. — View Citation

Pandey C, Rokaya D, Bhattarai BP. Contemporary Concepts in Osseointegration of Dental Implants: A Review. Biomed Res Int. 2022 Jun 14;2022:6170452. doi: 10.1155/2022/6170452. eCollection 2022. — View Citation

Qu C, Luo F, Hong G, Wan Q. Effects of photobiomodulation therapy on implant stability and postoperative recovery: a systematic review and meta-analysis. Br J Oral Maxillofac Surg. 2022 Jun;60(5):e712-e721. doi: 10.1016/j.bjoms.2022.01.014. Epub 2022 Feb 5. — View Citation

Swami V, Vijayaraghavan V, Swami V. Current trends to measure implant stability. J Indian Prosthodont Soc. 2016 Apr-Jun;16(2):124-30. doi: 10.4103/0972-4052.176539. — View Citation

Wang Y, Zhang Y, Miron RJ. Health, Maintenance, and Recovery of Soft Tissues around Implants. Clin Implant Dent Relat Res. 2016 Jun;18(3):618-34. doi: 10.1111/cid.12343. Epub 2015 Apr 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of osteolysis around dental implants	Assessing overall number of study subject that have developed osteolysis	4 months
Secondary	Active matrix metalloproteinase 8 (aMMP-8)	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
Secondary	Bleeding on probing (BOP)	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
Secondary	Probing Pocket Depth (PPD)	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

External Links

•   Amengual-Peñafiel. Osteoimmunology drives dental implant osseointegration: A new paradigm for implant dentistry. Japanese Dental Science Review 57 (2021) 12-19.
•   Moy. ISQ: What is it and how to use it in implant dentistry to improve clinical outcomes. International dentistry, 2011, Vol. 1, No. 4.