Photodynamic Treatment in the Management of Residual Biofilm - a Crossover Study

NCT06860321 | Completed

• 1 other identifier: PhoBCo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research introduces a home-use dual-light antibacterial medical device and its possible added value as part of traditional dental self-care. The aim of the study is to investigate, using a randomized cross-over study design, whether home-use dual-light antibacterial treatment is more effective in reducing residual biofilm than mechanical, traditional cleaning of teeth and interdental spaces.

Conditions

Healthy Adults; Plaque, Dental

Keywords

aPDT; photodynamic treatment; plaque control

Outcome Measures

Primary Outcomes (1)

• Rustogi plaque index

  The index divides the outer or inner surface of the tooth into 9 parts, based on which the amount of plaque is scored. Each tooth can score a maximum of 18 points and a minimum of 0 points at the analysis stage. The more points, the more plaque on the tooth surface is recorded

  30 minutes

Study Arms (2)

Group A day 1, and Group B day 2

ACTIVE COMPARATOR

1\) and 2) Electric toothbrushing and flossing, plaque staining and dental scan performed twice.

Other: Regular oral self care

Group A day 2, and Group B day 1

EXPERIMENTAL

1. One minute of Lumorinse mouth rinse swishing followed by 10 minutes of Lumoral device use, followed by electric toothbrushing and flossing. 2. Electric toothbrushing and flossing, plaque staining and dental scan performed twice.

Device: Adjunct antibacterial home-use dual-light medical device

Interventions

Adjunct antibacterial home-use dual-light medical device DEVICE

Crossover active intervention.

Group A day 2, and Group B day 1

Regular oral self care OTHER

Crossover regular intervention.

Group A day 1, and Group B day 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent voluntarily
• Good general health

You may not qualify if:

• Periodontitis
• Inability to perform regular oral self-care

Sponsors & Collaborators

• Metropolia University of Applied Sciences: collaborator
• Koite Health Oy: lead

Study Sites (1)

Oral Hammaslääkärit, Helsinki Bulevardi

Helsinki, Finland

Location

Related Publications (12)

• Bashir NZ, Singh HA, Virdee SS. Indocyanine green-mediated antimicrobial photodynamic therapy as an adjunct to periodontal therapy: a systematic review and meta-analysis. Clin Oral Investig. 2021 Oct;25(10):5699-5710. doi: 10.1007/s00784-021-03871-2. Epub 2021 Mar 12.

  PMID: 33710461 BACKGROUND

• Cieplik F, Deng D, Crielaard W, Buchalla W, Hellwig E, Al-Ahmad A, Maisch T. Antimicrobial photodynamic therapy - what we know and what we don't. Crit Rev Microbiol. 2018 Sep;44(5):571-589. doi: 10.1080/1040841X.2018.1467876. Epub 2018 May 11.

  PMID: 29749263 BACKGROUND

• Huang YY, Sharma SK, Carroll J, Hamblin MR. Biphasic dose response in low level light therapy - an update. Dose Response. 2011;9(4):602-18. doi: 10.2203/dose-response.11-009.Hamblin. Epub 2011 Sep 2.

  PMID: 22461763 BACKGROUND

• Karu T. Primary and secondary mechanisms of action of visible to near-IR radiation on cells. J Photochem Photobiol B. 1999 Mar;49(1):1-17. doi: 10.1016/S1011-1344(98)00219-X.

  PMID: 10365442 BACKGROUND

• Kessel D. Photodynamic Therapy: A Brief History. J Clin Med. 2019 Oct 2;8(10):1581. doi: 10.3390/jcm8101581.

  PMID: 31581613 BACKGROUND

• Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.

  PMID: 35723308 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

• Nikinmaa S, Podonyi A, Raivio P, Meurman J, Sorsa T, Rantala J, Kankuri E, Tauriainen T, Patila T. Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus. Antibiotics (Basel). 2021 Oct 13;10(10):1240. doi: 10.3390/antibiotics10101240.

  PMID: 34680821 BACKGROUND

• Pakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206.

  PMID: 36354651 BACKGROUND

• Parker S. The use of diffuse laser photonic energy and indocyanine green photosensitiser as an adjunct to periodontal therapy. Br Dent J. 2013 Aug;215(4):167-71. doi: 10.1038/sj.bdj.2013.790.

  PMID: 23969654 BACKGROUND

• Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9-12.

  PMID: 1306676 BACKGROUND

• Stajer A, Kajari S, Gajdacs M, Musah-Eroje A, Barath Z. Utility of Photodynamic Therapy in Dentistry: Current Concepts. Dent J (Basel). 2020 May 7;8(2):43. doi: 10.3390/dj8020043.

  PMID: 32392793 BACKGROUND

Related Links

• Hentilä, J. et al. (2021). Dual-Light Photodynamic Therapy Effectively Eliminates Streptococcus Oralis Biofilms. JoP\&PS 24.
• WHO. 2022. Global oral health status report: towards universal health coverage for oral health by 2030. Geneva.

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mikko Kylmänen, Master of Health Care

  Koite Health Oy

  STUDY DIRECTOR

• Saila Pakarinen, Master of Arts in Education

  Metropolia University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects are randomly divided into two group A and B. Data will be collected in two non-consecutive days to allow time for biofilm to re-form in the mouth. On study day 1, in both groups, teeth are cleaned at the study site by the participants themselves with an electric toothbrush and appropriate interdental cleaning tools, followed by plaque staining. The teeth are then scanned thoroughly with an oral scanner. Group A participants will perform a second dental cleaning themselves with an electric toothbrush and appropriate interdental cleaning tools, followed by plaque staining and scanning. Group B participants will perform a second dental cleaning themselves with Lumoral according to manufacture's instructions, followed by cleaning themselves with an electric toothbrush and appropriate interdental cleaning tools, followed by plaque staining and scanning. On study day 2, groups A and B will swap places and perform the same procedures as the other group on study day 1.

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 6, 2025
• Study Start: March 29, 2025
• Primary Completion: July 8, 2025
• Study Completion: July 9, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)