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New Multicenter Randomized Trial: Daily Home-Applied Dual-Light Therapy Improves Key Periodontitis Outcomes When Added to Standard Care

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The new LumoNorth2022 multicenter trial provides additional evidence for the recently published large HOPE-CP study. Together, the two randomized clinical trials suggest that daily at-home Lumoral® dual-light therapy supports professional periodontal care and improves gum health between dental visits.

A new multicenter, randomized, controlled clinical trial published in the Journal of Periodontology reports that daily at-home use of Lumoral® dual-light antibacterial therapy, when added to standard periodontal maintenance care, produced significantly greater improvements in gum inflammation, plaque, deep periodontal pockets, and clinical attachment level compared with supportive periodontal care (SPC) alone over six months.

Periodontitis is a common gum disease that damages the tissues supporting the teeth. If left untreated or poorly controlled, it can lead to deepened gum pockets, loss of tooth support, and eventually tooth loss. Professional dental care, toothbrushing, and cleaning between the teeth remain the foundation of treatment. The new findings suggest that Lumoral provides additional support as part of a patient’s daily home-care routine.

The LumoNorth2022 study was carried out at three dental clinics in Northern Finland. Forty adults with Stage I–III periodontitis were randomized to receive either standard supportive periodontal care alone or the same care combined with daily at-home use of Lumoral. Thirty-four participants completed the six-month follow-up and were included in the final analysis.

KEY FINDINGS

Bleeding on probing (BOP). Both groups improved. The reduction was significantly greater in the Lumoral group at the 6-month endpoint, with BOP falling from 40.2% to 22.0% in the Lumoral group versus 35.5% to 26.5% in the SPC group (between-group p = 0.03).

Visual plaque index (VPI). VPI dropped from 20.9% to 10.6% in the Lumoral group at six months (p = 0.04). No statistically significant within-group change was observed in the SPC-only arm.

Deep periodontal pockets (PPD ≥ 4 mm). The number of sites with pockets at or above 4 mm fell significantly in the Lumoral group at both three months (p = 0.0019) and six months (p = 0.0043). No statistically significant change was observed in the SPC-only group.

Clinical attachment level (CAL). CAL improved in the Lumoral group at three months (p = 0.0065) and six months (p = 0.0122). No statistically significant change was observed in the SPC-only group.

Safety. No device-related serious adverse events were reported. One participant reported a mild warming sensation and continued in the study; one device mouthpiece was replaced. Adherence averaged 81% over the study period.

CONTEXT: TWO POSITIVE RANDOMIZED TRIALS IN 2026

The LumoNorth2022 findings are consistent with the recently published HOPE-CP study, a larger randomized clinical trial involving 200 periodontitis maintenance patients. In HOPE-CP, patients who used Lumoral in addition to supportive periodontal care had significantly less gum bleeding, less visible plaque, and fewer deeper periodontal pockets after six months than patients receiving supportive care alone.

“Two independent randomized trials now point in the same direction. Daily, low-burden home use of dual-light therapy appears to meaningfully complement professional periodontal care. This approach should not be viewed as a replacement for scaling, root planing, or clinical maintenance, but as a daily home tool that helps the standard of care more effectively between visits.”

Dr. Tommi Pätilä, co-founder, Koite Health Ltd., and corresponding author of the LumoNorth2022 study

STUDY LIMITATIONS AND INTERPRETATION

 As with all clinical studies, the findings should be interpreted considering the study design. LumoNorth2022 was a relatively small trial: 40 patients were randomized, and 34 were included in the six-month analysis. At the same time, its multicenter design strengthens the relevance of the findings, as the results were observed across more than one clinical setting rather than at a single site.

As is typical for device-based and procedural periodontal studies, full blinding was not feasible because the device produces visible light and a mild warming sensation during use. This limitation was addressed in the peer-review process and should be understood in the wider context of periodontal research: many guideline-supported periodontal treatments, including scaling and root planing, are hands-on or device-based procedures that cannot be blinded in the same way as a tablet and placebo in a drug trial.

The study did not include smokers or patients with poorly controlled diabetes, so the results may not directly apply to those groups.

ABOUT LUMORAL

Lumoral® is a CE-marked medical device for home use, developed and manufactured by Koite Health Ltd. The treatment pairs a water-soluble mouth rinse tablet containing indocyanine green (ICG) with a dual-wavelength LED mouthpiece (405 nm and 810 nm), over a 10-minute treatment that the device times automatically. Lumoral is intended as an adjunct to daily oral hygiene and professional dental care.

ABOUT KOITE HEALTH

Koite Health Ltd. is a Finnish medical technology company developing dual-light antibacterial therapies for home use in oral health. The company is headquartered in Espoo, Finland. Koite Health funded the LumoNorth2022 study as study sponsor. Detailed conflict-of-interest disclosures are listed in the published paper: Dr. Tommi Pätilä is a co-founder and shareholder of Koite Health; Prof. Timo Sorsa holds stock in Koite Health; all other investigators reported no conflicts of interest related to this research.

STUDY REFERENCE

Tegelberg P, Ojala M, Ylipalosaari M, Lindroth J, Heikkinen AM, Lähteenmäki H, Pakarinen S, Räisänen IT, Sorsa T, Pätilä T. A multicenter, controlled, randomized trial of home-applied dual-light photodynamic therapy in stage I to III periodontitis (LumoNorth2022 study). Journal of Periodontology. 2026;1–11. DOI: 10.1002/jper.70120

Trial registration: ClinicalTrials.gov NCT05425784 (registered 15 June 2022).

# # #

Mikko Kylmänen

Clinical Project Manager

Koite Health

phone +358 40 724 5934

mikko.kylmanen@koitehealth.com

www.lumoral.com

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