Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health

Periodontitis Clinical Trial

Official title:

Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05361590
• Other study ID #: DPS-01
• Status: Completed
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: August 16, 2023

Study information

• Verified date: September 2023
• Source: Koite Health Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This early-stage study is designed to determine the efficacy of the CE-approved, antibacterial, dual-light Lumoral method in periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Description:

Dental plaque triggers changes in gingival health, which results in slight swelling and bleeding from the gingival margin and causes gingivitis. Supragingival dental biofilm control can be achieved by mechanical and chemical means. Toothbrushing is effective in reducing levels of dental plaque (van der Weijden & Slot 2015). It removes plaque from flat, accessible surfaces but is less effective at the gingival margins and in approximal areas, where the accumulation of residual plaque encourages gingivitis and deterioration of periodontal health. Effective toothbrushing is also depending on a number of factors, e.g., age, knowledge, manual dexterity and motivation. Oral hygiene instructions and patient motivation in oral hygiene practices should be an integral part of the patient management during all stages of periodontal treatment (Tonetti et al., 2015). Oral health practice of individuals affects their gingival and periodontal health.

The Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy. The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

This early-stage study is designed to determine the efficacy of the Lumoral method in periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Forty (40) patients are randomized to the Lumoral treatment group or the control group. Both groups shall receive standard oral hygiene instructions for sonic toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontal status including visible plaque index (VPI), bleeding on probing (BOP) and probing pocket depth (PPD). In addition, aMMP-8 mouth rinse test and microbiological analysis of gingival pockets will be performed. Digital photographs after staining will be taken. These analyses shall be performed at baseline and at 4 weeks after the treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• At least 18 years old

• Agreement to participate in the study and to sign a written consent form

Exclusion Criteria:

• Presence of any physical limitation or restriction that might restrict Lumoral use

• Pregnancy or lactation

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis
• Periodontitis
• Plaque Induced Gingivitis
• Plaque, Dental

Intervention

Device:
• Lumoral device
The Lumoral treatment -device is a CE-marked antibacterial home-use device for the treatment and prevention of oral diseases caused by bacteria. It is used in combination with a CE-marked mouth rinse called Lumorinse.

Locations

Country	Name	City	State
Finland	Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care	Tampere	Pirkanmaa

Sponsors (3)

Lead Sponsor	Collaborator
Koite Health Oy	Tampere University, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BoP	Reduction in bleeding on probing (BoP).; Procedure for BoP: A full-mouth assessment at six sites per tooth; Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus; Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent"; BOP reported as the percentage (%) of sites with positive findings; Calculation formula: number of bleeding sites/ 6 times number of teeth	4 weeks
Secondary	Microbiological pathogens	Change in periodontal microbiological pathogens. The plaque sample will be taken from the teeth with =3 mm pockets with a sterile paper point. If the subject does not have any deep periodontal pockets, then a sample will be taken from shallow sites. Prior to sampling, the supragingival plaque will be removed with a curette. The paper point will be then taken to the gingival pocket with sterile tweezers. The paper pin will be allowed to stand for 10 to 20 seconds, after which it will be removed and sealed in an empty plastic sample transport tube.; A gene amplification method (polymerase chain reaction, PCR) will be used to look for six key bacteria in periodontitis: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia and Parvimonas micra.	4 weeks
Secondary	aMMP-8	Reduction in periodontal inflammation marker aMMP-8. An aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions.	4 weeks
Secondary	VPI	Clinical improvement concerning visible plaque index (VPI).; Procedure for VPI: A full-mouth assessment, measured at 4 sites per tooth; Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent"; VPI reported as the percentage (%) of sites with plaque; Calculation formula: number of sites with plaque/ 4 times number of teeth	4 weeks
Secondary	PPD	Reduction in probing pocket depth (PPD).; Procedure for PPD: A full-mouth assessment, measured at six sites per tooth; Assessed from the base of the pocket to the gingival margin (mm).	4 weeks

External Links

•   Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review. Laser Dent Sci 3, 147-153 (2019
•   Chapple ILC, Mealey BL, Van Dyke TE et al., (2018). Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-
•   Gomes SC, Romagna R, Rossi V, Corvello PC, Melchiors-Angst PD. Supragingival treatment as an aid to reduce subgingival needs: a 450-day investigation Braz. oral res. 28 (1) (2014)
•   Lähteenmäki H, Pätilä T, Räisänen IT, et al. (2022). Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease - A Pilot Study
•   Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.
•   Nikinmaa S, Alapulli H, Auvinen P, et al. (2020) Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. PLoS ONE 15(5): e0232775.
•   Nikinmaa S, Moilanen N, Sorsa T, et al. (2021a). Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque
•   Nikinmaa S, Podonyi A, Raivio P, et al. (2021b). Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus
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•   Sanz M, Herrera D, Kebschull M, et al.; On behalf of the EFP Workshop Participants and Methodological Consultants. (2020) Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol., 47: 4- 60.
•   Tonetti MS, Eickholz P, Loos BG et al., (2015). Principles in prevention of periodontal diseases: Consensus report of group 1 of the 11th European Workshop on Periodontology on effective prevention of periodontal and peri-implant diseases. Journal of
•   Van der Weijden FA & Slot DE (2015). Efficacy of homecare regimens for mechanical plaque removal in managing gingivitis: A metareview. Journal of Clinical Periodontology, 42(Suppl 16), S77-S91