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

Saila Pakarinen, Riitta K T Saarela, Hannamari Välimaa, Anna Maria Heikkinen, Esko Kankuri, Marja Noponen, Heikki Alapulli, Taina Tervahartiala, Ismo T Räisänen, Timo Sorsa, Tommi Pätilä, Saila Pakarinen, Riitta K T Saarela, Hannamari Välimaa, Anna Maria Heikkinen, Esko Kankuri, Marja Noponen, Heikki Alapulli, Taina Tervahartiala, Ismo T Räisänen, Timo Sorsa, Tommi Pätilä

Abstract

A single-site, randomized clinical trial was designed to determine the efficacy of regular home use of Lumoral® dual-light antibacterial aPDT in periodontitis patients. For the study, 200 patients were randomized to receive non-surgical periodontal treatment (NSPT), including standardized hygiene instructions and electric toothbrush, scaling and root planing, or NSPT with adjunctive Lumoral® treatment. A complete clinical intraoral examination was conducted in the beginning, at three months, and at six months. This report presents the three-month results of the first 59 consecutive randomized subjects. At three months, bleeding on probing (BOP) was lower in the NSPT + Lumoral®-group than in the NSPT group (p = 0.045), and more patients in the NSPT + Lumoral®-group had their BOP below 10% (54% vs. 22%, respectively, p = 0.008). In addition, patients in the NSPT + Lumoral®-group improved their oral hygiene by visible-plaque-index (p = 0.0003), while the NSPT group showed no statistical improvement compared to the baseline. Both groups significantly reduced the number of deep periodontal pockets, but more patients with a reduction in their deep pocket number were found in the NSPT + Lumoral® group (92% vs. 63%, p = 0.02). Patients whose number of deep pockets was reduced by 50% or more were also more frequent in the NSPT + Lumoral®-group (71% vs. 33%, p = 0.01). Patients with initially less than ten deep pockets had fewer deep pockets at the three-month follow-up in the Lumoral® group (p = 0.01). In conclusion, adjunctive use of Lumoral® in NSPT results in improved treatment outcomes at three months post-therapy.

Keywords: antibacterial photodynamic therapy; oral hygiene; periodontitis.

Conflict of interest statement

Timo Sorsa is the inventor of the following patents: 1274,416-patent U.S. 5,652,223, 5,736,341, 5,864,632, 6,143,476, and US 2017/0023571A1 (issued 6 June 2019); WO 2018/060553 A1 (issued 31 May 2010); 10,488,415 B2, Japanese Patent 2016-554676; and South Korean patent 10-2016-7025378. Tommi Pätilä is the Chairman of the board and owns stocks in Koite Health LTD. The company has filed patents P21233F100 and P22769F100 and owns trademarks related to antibacterial dual-light. Koite Health LTD develops, sells, and markets dual-light antibacterial products for the prevention and treatment of dental and periodontal infections.

Figures

Figure 1
Figure 1
Flow diagram according to the CONSORT protocol.
Figure 2
Figure 2
The dual-light aPDT Lumoral® device. (A) The device includes the Lumoral® light applicator and the effervescent Lumorinse® tablets (*) to be dissolved in 30 mL of water with a measuring cup (**). A power source (***) for the light applicator. (B). The mouthpiece (*) is composed of 48 LED components (**) assembled to provide simultaneous light on both the maxillary and mandibular dental arches. Each LED component emits 405 nm and 810 nm light simultaneously. A push of the control button provides a treatment time of 10 min (***). When dissolved, the ICG in the Lumorinse® tablet appears green.
Figure 3
Figure 3
(A) BOP (%) at the three-month visit. (B) The percentage of participants with BOP < 10% at the three-month visit. BOP = bleeding on probing, NSPT = non-surgical periodontal treatment.
Figure 4
Figure 4
(A) VPI (%) in the NSPT + Lumoral® group at the beginning of the study and three months. (B) VPI (%) in the NSPT group at the beginning of the study and three months. VPI = visual plaque index, NSPT = non-surgical periodontal treatment.
Figure 5
Figure 5
(A) Proportion of the patients who reduced the number of their deep periodontal pockets. (B) The number of patients with a reduction of 50% or more in the number of deep pockets at three months. (C) Number of deep pockets at three months in patients who had ten pockets or fewer at the beginning of the study. (D) The number of patients who presented no deep pockets at three months.

References

    1. Sanz M., Beighton D., Curtis M.A., Cury J.A., Dige I., Dommisch H., Ellwood R., Giacaman R.A., Herrera D., Herzberg M.C., et al. Role of microbial biofilms in the maintenance of oral health and in the development of dental caries and periodontal diseases. Consensus report of group 1 of the Joint EFP/ORCA workshop on the boundaries between caries and periodontal disease. J. Clin. Periodontol. 2017;44((Suppl. 18)):S5–S11. doi: 10.1111/jcpe.12682.
    1. 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;44:571–589. doi: 10.1080/1040841X.2018.1467876.
    1. Konopka K., Goslinski T. Photodynamic Therapy in Dentistry. J. Dent. Res. 2007;86:694–707. doi: 10.1177/154405910708600803.
    1. Wang Y., Wang Y., Wang Y., Murray C.K., Hamblin M.R., Hooper D.C., Dai T. Antimicrobial blue light inactivation of pathogenic microbes: State of the art. Drug Resist. Updat. 2017;33–35:1–22. doi: 10.1016/j.drup.2017.10.002.
    1. Lins de Sousa D., Araújo Lima R., Zanin I.C., Klein M.I., Janal M.N., Duarte S. Effect of Twice-Daily Blue Light Treatment on Matrix-Rich Biofilm Development. PLoS ONE. 2015;10:e0131941. doi: 10.1371/journal.pone.0131941.
    1. Herrera D. Insufficient evidence for photodynamic therapy use in periodontitis. Evid.-Based Dent. 2011;12:46. doi: 10.1038/sj.ebd.6400791.
    1. Chambrone L., Wang H.-L., Romanos G.E. Antimicrobial photodynamic therapy for the treatment of periodontitis and peri-implantitis: An American Academy of Periodontology best evidence review. J. Periodontol. 2018;89:783–803. doi: 10.1902/jop.2017.170172.
    1. Smiley C.J., Tracy S., Abt E., Michalowicz B.S., John M.T., Gunsolley J., Cobb C.M., Rossmann J., Harrel S.K., Forrest J.L., et al. Systematic review and meta-analysis on the nonsurgical treatment of chronic periodontitis by means of scaling and root planing with or without adjuncts. J. Am. Dent. Assoc. 2015;146:508–524.e5. doi: 10.1016/j.adaj.2015.01.028.
    1. Lähteenmäki H., Pätilä T., Räisänen I.T., 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;44:1273–1283. doi: 10.3390/cimb44030085.
    1. Giannelli M., Materassi F., Fossi T., Lorenzini L., Bani D. Treatment of severe periodontitis with a laser and light-emitting diode (LED) procedure adjunctive to scaling and root planing: A double-blind, randomized, single-center, split-mouth clinical trial investigating its efficacy and patient-reported outcomes at 1 year. Lasers Med. Sci. 2018;33:991–1002. doi: 10.1007/s10103-018-2441-9.
    1. Giannelli M., Formigli L., Lorenzini L., Bani D. Efficacy of Combined Photoablative-Photodynamic Diode Laser Therapy Adjunctive to Scaling and Root Planing in Periodontitis: Randomized Split-Mouth Trial with 4-Year Follow-Up. Photomed. Laser Surg. 2015;33:473–480. doi: 10.1089/pho.2015.3955.
    1. Nikinmaa S., Alapulli H., Auvinen P., Vaara M., Rantala J., Kankuri E., Sorsa T., Meurman J., Pätilä T. Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. PLoS ONE. 2020;15:e0232775. doi: 10.1371/journal.pone.0232775.
    1. Nikinmaa S., Moilanen N., Sorsa T., Rantala J., Alapulli H., Kotiranta A., Auvinen P., Kankuri E., Meurman J., Pätilä T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent. J. 2021;9:52. doi: 10.3390/dj9050052.
    1. Nikinmaa S., Podonyi A., Raivio P., Meurman J., Sorsa T., Rantala J., Kankuri E., Tauriainen T., Pätilä T. Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus. Antibiotics. 2021;10:1240. doi: 10.3390/antibiotics10101240.
    1. Trujiilo K., Räisänen I.T., Sorsa T., Pätilä T. Repeated Daily Use of Dual-Light Antibacterial Photodynamic Therapy in Periodontal Disease—A Case Report. Dent. J. 2022;10:163. doi: 10.3390/dj10090163.
    1. Lang N.P., Adler R., Joss A., Nyman S. Absence of bleeding on probing An indicator of periodontal stability. J. Clin. Periodontol. 1990;17:714–721. doi: 10.1111/j.1600-051X.1990.tb01059.x.
    1. Schär D., Ramseier C.A., Eick S., Mettraux G., Salvi G.E., Sculean A. Transgingival photodynamic therapy (tg-aPDT) adjunctive to subgingival mechanical instrumentation in supportive periodontal therapy. A randomized controlled clinical study. Photodiagnosis Photodyn. Ther. 2020;32:101971. doi: 10.1016/j.pdpdt.2020.101971.
    1. Joshi K., Baiju C.S., Khashu H., Bansal S. Clinical effectiveness of indocyanine green mediated antimicrobial photodynamic therapy as an adjunct to scaling root planing in treatment of chronic periodontitis-A randomized controlled clinical trial. Photodiagn. Photodyn. Ther. 2019;29:101591. doi: 10.1016/j.pdpdt.2019.101591.
    1. Monzavi A., Chinipardaz Z., Mousavi M., Fekrazad R., Moslemi N., Azaripour A., Bagherpasand O., Chiniforush N. Antimicrobial photodynamic therapy using diode laser activated indocyanine green as an adjunct in the treatment of chronic periodontitis: A randomized clinical trial. Photodiagn. Photodyn. Ther. 2016;14:93–97. doi: 10.1016/j.pdpdt.2016.02.007.
    1. Chiang C.-P., Hsieh O., Tai W.-C., Chen Y.-J., Chang P.-C. Clinical outcomes of adjunctive indocyanine green-diode lasers therapy for treating refractory periodontitis: A randomized controlled trial with in vitro assessment. J. Formos. Med. Assoc. 2019;119:652–659. doi: 10.1016/j.jfma.2019.08.021.
    1. Gandhi K.K., Pavaskar R., Cappetta E.G., Drew H.J. Effectiveness of Adjunctive Use of Low-Level Laser Therapy and Photodynamic Therapy After Scaling and Root Planing in Patients with Chronic Periodontitis. Int. J. Periodontics Restor. Dent. 2019;39:837–843. doi: 10.11607/prd.4252.
    1. Sanz M., Herrera D., Kebschull M., Chapple I., Jepsen S., Berglundh T., Sculean A., Tonetti M.S., Aass A.M., Aimetti M., et al. Treatment of stage I–III periodontitis—The EFP S3 level clinical practice guideline. J. Clin. Periodontol. 2020;47:4–60. doi: 10.1111/jcpe.13290.
    1. Hentilä J., Laakamaa N., Sorsa T., Meurman J., Välimaa H., Nikinmaa S., Kankuri E., Tauriainen T., Pätilä T. Dual-Light Photodynamic Therapy Effectively Eliminates Streptococcus Oralis Biofilms. J. Pharm. Pharm. Sci. 2021;24:484–487. doi: 10.18433/jpps32084.
    1. Alander J.T., Kaartinen I., Laakso A., Pätilä T., Spillmann T., Tuchin V.V., Venermo M., Välisuo P. A Review of Indocyanine Green Fluorescent Imaging in Surgery. Int. J. Biomed. Imaging. 2012;2012:940585. doi: 10.1155/2012/940585.
    1. Moro M.G., de Carvalho V.F., Godoy-Miranda B.A., Kassa C.T., Horliana A.C.R.T., Prates R.A. Efficacy of antimicrobial photodynamic therapy (aPDT) for nonsurgical treatment of periodontal disease: A systematic review. Lasers Med. Sci. 2021;36:1573–1590. doi: 10.1007/s10103-020-03238-1.
    1. Bashir N.Z., Singh H.-A., Virdee S.S. Indocyanine green–mediated antimicrobial photodynamic therapy as an adjunct to periodontal therapy: A systematic review and meta-analysis. Clin. Oral Investig. 2021;25:5699–5710. doi: 10.1007/s00784-021-03871-2.
    1. Sculean A., Deppe H., Miron R., Schwarz F., Romanos G., Cosgarea R. Effectiveness of photodynamic therapy in the treatment of periodontal and peri-implant diseases. Oral Biofilms. 2021;29:133–143. doi: 10.1159/000510189.
    1. Dalvi S., Benedicenti S., Hanna R. Effectiveness of Photobiomodulation as an Adjunct to Nonsurgical Periodontal Therapy in the Management of Periodontitis—A Systematic Review of in vivo Human Studies. Photochem. Photobiol. 2020;97:223–242. doi: 10.1111/php.13348.
    1. National Institute for Health and Care Excellence Low-Level Laser Therapy for Preventing or Treating Oral Mucositis Caused by Radiotherapy or Chemotherapy. NICE Interventional Procedures Guidance [IPG615] 2018. [(accessed on 23 May 2018)]. Available online: .
    1. Peng H., Chen B.-B., Chen L., Chen Y.-P., Liu X., Tang L.-L., Mao Y.-P., Li W.-F., Zhang Y., Lin A.-H., et al. A network meta-analysis in comparing prophylactic treatments of radiotherapy-induced oral mucositis for patients with head and neck cancers receiving radiotherapy. Oral Oncol. 2017;75:89–94. doi: 10.1016/j.oraloncology.2017.11.001.
    1. Figuero E., Roldán S., Serrano J., Escribano M., Martín C., Preshaw P.M. Efficacy of adjunctive therapies in patients with gingival inflammation: A systematic review and meta-analysis. J. Clin. Periodontol. 2019;47:125–143. doi: 10.1111/jcpe.13244.

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