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

NCT06041828 | Withdrawn

• 1 other identifier: LumOsteo
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteolysis; Dental Implants

Keywords

Lumoral; Dental implant; Osteolysis; Anti-bacterial photodynamic therapy; Oral hygiene

Outcome Measures

Primary Outcomes (1)

• Incidence of osteolysis around dental implants

  Assessing overall number of study subject that have developed osteolysis

  4 months

Secondary Outcomes (3)

• Active matrix metalloproteinase 8 (aMMP-8)

  4 months

• Bleeding on probing (BOP)

  4 months

• Probing Pocket Depth (PPD)

  4 months

Study Arms (2)

Study group

EXPERIMENTAL

Standard oral hygiene and Lumoral Treatment home-use

Device: Lumoral Treatment; Other: Standard oral hygiene

Control group

ACTIVE COMPARATOR

Standard oral hygiene only

Other: Standard oral hygiene

Interventions

Lumoral Treatment DEVICE

Photodynamic antibacterial dual-light device with a marker substance

Study group

Standard oral hygiene OTHER

Standard oral hygiene instructions

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koite Health Oy: lead
• Hammaslääkärit Eteläranta 10: collaborator
• University of Helsinki: collaborator

Study Sites (1)

Hammaslääkärit Eteläranta 10

Helsinki, Uusimaa, 00130, Finland

Location

Related 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.

  PMID: 32503238 BACKGROUND

• Gupta R, Gupta N, Weber, DDS KK. Dental Implants. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470448/

  PMID: 29262027 BACKGROUND

• 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.

  PMID: 32983857 BACKGROUND

• 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.

  PMID: 34063662 BACKGROUND

• 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.

  PMID: 35747499 BACKGROUND

• 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.

  PMID: 27141160 BACKGROUND

• 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.

  PMID: 35490059 BACKGROUND

• 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.

  PMID: 25873299 BACKGROUND

Related Links

• Amengual-Peñafiel. Osteoimmunology drives dental implant osseointegration: A new paradigm for implant dentistry. Japanese Dental Science Review 57 (2021) 12-19.
• Elias. Factors Affecting the Success of Dental Implants. Implant dentistry, Aug 2011. DOI: 10.5772/18746
• Gupta et al. Implant Stability Quotient (ISQ): A Reliable Guide for Implant Treatment. Current Concepts in Dental Implantology. 2021. DOI: 10.5772/intechopen.101359

MeSH Terms

Conditions

Osteolysis

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Timo Sorsa, Professor

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data will be collected using individual study codes for participants. Study codes do not reveal which group the participant has belonged to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized clinical study on a medical device.

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)