Scientific papers

Ongoing and planned studies

Periodontitis / Oral Hygiene

KHE2021 Metro / HOPE-CP - Periodontitis stage 1-3
• Timo Sorsa, Saila Pakarinen, Hanna-Mari Välimaa, Marja Noponen, Heikki Alapulli, Petri Auvinen
• 100+100 patients
• Sponsored, prospective, randomized
• Started: March 2022
• ClinicalTrials.gov ID: NCT05278416
• Preliminary results: https://doi.org/10.3390/dj10110206

LumoNorth2022 - Periodontitis stage 1-3
• Timo Sorsa, Paula Tegelberg, Meeri Ojala, Merja Ylipalosaari, Jori Lindroth, Petri Auvinen
• 45+45 patients
• Sponsored, prospective randomized, multicenter
• Started: Jan 2023
• ClinicalTrials.gov ID: NCT05425784

THSS1 - Smoking periodontitis patients
• Dimitra Sakellari, Timo Sorsa, Chrysoula Vakaki, Aikaterini- Elisavet Doufexi, Ismo Räisänen, Tommi Pätilä
• 30+30 patients
• Investigator-initiated, prospective, randomized, blinded
• Started Jan 2023
• ClinicalTrials.gov ID: NCT05962801

LumoKaunas2023, Periodontitis stage 3-4
• Ingrida Marija Pacauskienė, Nomeda Basevičienė, Vita Mačiulskienė, Raimonda Guntulytė, Alma Pranckevičienė, Renata Šadzevičienė, Petri Auvinen, Ismo Räisänen, Timo Sorsa
• Sponsored, prospective, randomized
• Started June 2023
• ClinicalTrials.gov ID: NCT05698823

LumoKoti, oral hygiene with elderly people living at home or at care home
• Timo Sorsa, Harry Niskanen, Pekka Kallio, Tommi Pätilä, Katja Gustafsson, Karim Abdalla
• Investigator-initiated, prospective, randomized
• Estimated start: Q2-Q3/2024
• ClinicalTrials.gov ID: TBA

Peri-implant disease

IS-2022 Enhanced oral hygiene effect on the implant success rate
• Hellevi Ruokonen, Karita Nylund, Timo Sorsa, Tommi Pätilä, Patricia Stoor, Nina-Li Avellán, Kirsten Besuch, Viivi Mattila, Petri Auvinen
• Investigator-initiated, prospective, randomized
• Started: Sep 2022

IS-TRE Prevention of peri-implant diseases
• Hanna Lähteenmäki, Timo Sorsa, Tommi Pätilä, Ismo Räisänen
• Investigator-initiated, prospective, randomized
• Study ended: July 2023
• Study report by Q2/2024
• ClinicalTrials.gov ID: NCT05871229

Severe peri-implantitis
• Nilminie Rathnayake, Timo Sorsa, Taina Tervahartiala, Akke Kumlien, Tommi Pätilä
• Investigator-initiated, prospective, randomized
• Estimated start: Q1/2024
• ClinicalTrials.gov ID: NCT06017817

Immunologically mediated mucocutaneous diseases

OLP-01TRE Treatment of oral lichen planus
• Anna Maria Heikkinen, Kati Ylä-Tuuhonen, Timo Sorsa, Jaana Hagström, Ulla Kotiranta, Taina Tervahartiala, Esko Kankuri, Outi Majala
• Sponsored, prospective, randomized
• Started: Jan 2023
• ClinicalTrials.gov ID: NCT05401201

Orthodontics

CLEAN-BRACKET Fixed orthodontic treatment in adolescents
• Ann-Marie Roos Jansåker, Katja Elses, My Blomqvist, Petri Auvinen
• Sponsored, prospective, randomized
• Started: Nov 2023
• ClinicalTrials.gov ID: NCT05825742

LumOsteo Prevention of osteolysis after dental implant surgery
• Pekka Kallio, Timo Strandén
• Investigator-initiated, prospective, randomized
• Estimated start: Q1/2024
• ClinicalTrials.gov ID: NCT06041828

Other

RSAA2021 Enhanced oral hygiene on elderly care home residents
• Riitta Saarela, Tommi Pätilä, Timo Sorsa, Jaana Helenius-Hietala, Anna Maria Heikkinen, Saila Pakarinen, Sakari Nikinmaa, Taina Tervahartiala, Sanna Korte, Wilma Romppanen, Tuuli Seitsamo
• Investigator-initiated, prospective, randomized
• Started: September 2022
• ClinicalTrials.gov ID: NCT05853679

Cleft palate operations - Enhanced oral hygiene
• Elisa Ronkainen, Juho Suojanen, Junnu Leikola, Arja Heliövaara
• Investigator-initiated, prospective
• Started: 2020

LumoPrevent / Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases
• Anna Maria Heikkinen, Milla Sarja, Teija Raivisto, Ismo Räisänen, Tommi Pätilä, Timo Sorsa, Saila Pakarinen
• Investigator-initiated, prospective, randomized
• Started: April 2024
• ClinicalTrials.gov ID: NCT06286501

APDT-T2D, management and prevention of periodontitis symptoms in diabetic patients
• Anna Maria Heikkinen, Patrick Saikkonen, Miia Ehrnrooth, Timo Sorsa, Andreas Pfuetzner, Marko Helenius, Pirkko Pussinen, Atte Vadén, Tommi Pätilä, Timo Kauppila
• Investigator-initiated, prospective, randomized
• Estimated start: Q3/2024
• ClinicalTrials.gov ID: TBA

Published studies

Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)—Three-Month Interim Results

Adjunctive use of Lumoral dual-light antibacterial aPDT in non-surgical periodontal treatment (NSPT) results in improved treatment outcomes at three months post-therapy.

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Repeated Daily Use of Dual-Light Antibacterial Photodynamic Therapy in Periodontal Disease—A Case Report

Good oral hygiene at home is the foundation for optimal treatment response and long-term periodontal disease control. Antibacterial photodynamic therapy (aPDT) provides a potent adjunctive treatment for plaque control. However, literature regarding repeated aPDT use has been so far sparse. A new case study presentvery positive results and clinical outcome of daily applied dual-light aPDT-technology treatment in conjunction with mechanical cleaning of a 78-year-old male patient with severe periodontal disease (Stage IV and Grade B).

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Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease—A Pilot Study

This pilot study tested the benefit of a commercially available Lumoral® device designed for regular periodontal dual-light aPDT treatment at home. Seven patients with peri-implant disease applied dual-light aPDT daily in addition to their normal dental hygiene for four weeks. The results suggest a benefit of regular application of dual-light aPDT in peri-implantitis. Frequently repeated application can be a promising approach to diminishing the microbial burden and to lowering the tissue destructive proteolytic and inflammatory load around dental implants.

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Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation

Antibacterial photodynamic therapy (aPDT) and antibacterial blue light (aBL) are emerging treatment methods auxiliary to mechanical debridement for periodontitis. In this study, we tested Streptococcus mutans biofilm sensitivity to either aPDT, aBL or their combination dual-light aPDT (simultaneous aPDT and aBL) exposure. In conclusion, when aPDT is administered repeatedly to S. mutans biofilm, a single wavelength-based aBL or aPDT leads to a significant biofilm adaptation and increased S. mutans viability. The combined use of aBL light in synchrony with aPDT arrests the adaptation and provides significantly improved and sustained antibacterial efficacy.

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La Terapia Fotodinámica Domiciliaria Como Medio De Prevención Para El Control Del Biofilm

A patient case study -  a patient with staining from chromogenic bacteria, gingival inflammation and pain had Lumoral protocol at home for 45 consecutive days as an adjunctive method for home care, together with an extra soft toothbrush. 

The 3-month check-up showed restitutio ad integrum and healthy gingival tissues, the absence of bleeding at the time of treatment and the absence of bleeding at the end of the treatment. healthy gingival tissues, the absence of bleeding on periodontal probing, good biofilm control and an improvement in oral hygiene techniques.

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Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque

Antimicrobial photodynamic therapy (aPDT) has been introduced as an adjunct method for dental hygiene.
Although antibacterial and antiplaque effects resulting from aPDT have already been demonstrated in the literature, effects on bacterial flora diversity or early gingivitis biomarkers have not previously been established.

Antimicrobial photodynamic therapy resulted in a significant reduction of plaque formation. An analysis of the 16S rRNA sequencing found a reduction in the Streptococcus, Acinetobacterial, Capnocytophagal, and Rothia bacteria species and a gain in Neisseria and Hemophilus bacteria on the aPDT-treated side. The gain in the latter group of bacteria superseded the relative loss of the former in the plaque, while alpha diversity remained stable.
A reduction of the total amount of MMP-8 in the GCF was seen on the treated side, suggesting inhibition of early gingivitis.

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Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus

New means to reduce excessive antibiotic use are urgently needed. This study tested dual-light aPDT against Staphylococcus aureus biofilm with different relative ratios of light energy with indocyanine green.

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Dual-Light Photodynamic Therapy Effectively Eliminates Streptococcus Oralis Biofilms

During cancer treatment, oral mucositis due to radiotherapy or chemotherapy often leads to disruption of the oral mucosa, enabling microbes to invade bloodstream. Viridans streptococcal species are part of the healthy oral microbiota but can be frequently isolated from the blood of neutropenic patients. We have previously shown the antibacterial efficacy of dual-light, the combination of antibacterial blue light (aBL) and indocyanine green photodynamic therapy (aPDT). 

The dual-light had a significant antibacterial effect in all the tested combinations. Dual-light can be used as an effective disinfectant against S. oralis biofilm.

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Tero Pasanen – CCO
tero.pasanen(at)koitehealth.com
+358 40 045 9080

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Riikka Nisula – Lumoral Area Manager
riikka.nisula(at)koitehealth.com
+358 40 753 3214

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Emilia Kataja – Lumoral Area Manager
emilia.kataja(at)koitehealth.com
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Helen Huttunen – Country Manager
helen.huttunen(at)koitehealth.com
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