A Multicenter, Controlled, Randomized Trial of Home-Applied Dual-Light Photodynamic Therapy in Chronic Periodontitis

Abstract

Aim This multicenter, randomized controlled trial evaluated the efficacy of the Lumoral® dual-light antibacterial photodynamic (aPDT) home care device as an adjunct tool to non-surgical periodontal treatment (NSPT) in chronic periodontitis patients.

Materials and Methods Forty-one Stage I-III periodontitis patients were randomized to receive NSPT, including standardized hygiene instructions and scaling and root planing, or NSPT with adjunctive Lumoral® treatment, applied daily at home. Clinical examinations were conducted at baseline, three months, and six months.

Results Both groups showed significant reductions in Visual Plaque Index (VPI) and Bleeding on Probing (BOP) at three and six months. However, the NSPT + Lumoral® group exhibited significantly greater BOP and VPI reductions at six months (p=0.03, p=0.04) compared to the NSPT group. Incidence of Probing Pocket Depth (PPD) ≥ 4 mm reduced significantly in the NSPT + Lumoral® group at both follow-ups (p=0.0019, p=0.0043) but not in the NSPT group. Periodontal epithelial surface area (PESA) and periodontal inflamed surface area (PISA) significantly decreased in the NSPT + Lumoral® group (p<0.01), while no significant changes were observed in the control group.

Conclusion Regular adjunctive use of Lumoral® after NSPT resulted in improved clinical periodontitis treatment outcomes.

Competing Interest Statement

Tommi Patila owns stocks in Koite Health

Clinical Trial

ClinicalTrials.gov Identifier: NCT05425784

Funding Statement

Koite Health provided the devices used in the study.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Th ethics committee of Hospital District of Helsinki and Uusimaa gaveethical approval for this work

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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