Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment

NCT05825742 | Completed

• 1 other identifier: CLEAN-BRACKET
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine the efficacy of the Lumoral method on oral health in adolescents undergoing fixed orthodontic treatment. 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.

Conditions

Orthodontic Appliance Complication; Plaque, Dental; Gingival Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in Visible plaque index (VPI)

  * A full-mouth assessment, measured at six sites per tooth. * Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent" * VPI is reported as the percentage (%) of sites with plaque. * Calculation formula: number of sites with plaque/ 6 times number of teeth

  12 weeks

Secondary Outcomes (3)

• Change in Bleeding on probing (BOP)

  12 weeks

• Change in Orthodontic plaque index (OPI)

  12 weeks

• Change in periodontal microbiological flora

  12 weeks

Study Arms (2)

Lumoral Treatment (Study group)

EXPERIMENTAL

Subjects will receive detailed instructions for the use of Lumoral treatment -device. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day for two months and to keep a diary. Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

Device: Lumoral Treatment; Other: Standard oral health instructions

Standard of care (Control group)

OTHER

Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

Other: Standard oral health instructions

Interventions

Lumoral Treatment DEVICE

Subjects will receive detailed instructions for the use of Lumoral treatment -device. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day for two months and to keep a diary.

Lumoral Treatment (Study group)

Standard oral health instructions OTHER

Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

Lumoral Treatment (Study group); Standard of care (Control group)

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age of 15-18 years old
• starting fixed orthodontic treatment
• good oral hygiene according to the dentist's assessment
• absence of periodontal disease and lack of oral lesion
• signed a written consent form, including information to caregivers.

You may not qualify if:

• any chronic diseases
• medications that could influence the study (according to the dentists' assessment)
• active caries or a supposed high risk of caries
• gingivitis (bleeding on probing \>10%)
• use of antiseptic mouthwashes
• smoking
• use of antibiotics or anti-inflammatory therapy within 3 months before entering the study or during the study
• unable to cooperate with the protocol.
• pregnancy or lactation

Sponsors & Collaborators

• Koite Health Oy: lead
• University of Helsinki: collaborator
• Helsinki University Central Hospital: collaborator
• Borgska Villans Specialisttandvård: collaborator

Study Sites (1)

Borgska Villans Specialisttandvård

Lund, 22355, Sweden

Location

Related Publications (4)

• Erbe C, Klees V, Braunbeck F, Ferrari-Peron P, Ccahuana-Vasquez RA, Timm H, Grender J, Cunningham P, Adam R, Wehrbein H. Comparative assessment of plaque removal and motivation between a manual toothbrush and an interactive power toothbrush in adolescents with fixed orthodontic appliances: A single-center, examiner-blind randomized controlled trial. Am J Orthod Dentofacial Orthop. 2019 Apr;155(4):462-472. doi: 10.1016/j.ajodo.2018.12.013.

  PMID: 30935601 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

• Verrusio C, Iorio-Siciliano V, Blasi A, Leuci S, Adamo D, Nicolo M. The effect of orthodontic treatment on periodontal tissue inflammation: A systematic review. Quintessence Int. 2018;49(1):69-77. doi: 10.3290/j.qi.a39225.

  PMID: 29114647 BACKGROUND

• Walsh LJ, Healey DL. Prevention and caries risk management in teenage and orthodontic patients. Aust Dent J. 2019 Jun;64 Suppl 1:S37-S45. doi: 10.1111/adj.12671.

  PMID: 31144319 BACKGROUND

Related 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)
• Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.
• Linden J, Widström E \& Sinkkonen J (2019) Children and adolescents´ dental treatment in 2001-2013 in the Finnish public dental service. BMC Oral Health (2019) 19:131
• 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)
• Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease. Parkinsonism and Related Disorders 38: 61-67

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Ann-Marie Roos Jansåker, Professor

  Borgska Villans Specialisttandvård

  PRINCIPAL INVESTIGATOR

• Tommi Pätilä, Docent

  Koite Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The participants, care providers, and investigators shall be masked before the first measurements. The randomization will be conducted after the first measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants in two groups (Study group and Control group) shall receive instructions for standard oral hygiene. The same assessments are done for participants in both groups, and within the same time periods. The Study group will also be using the Lumoral Treatment device.

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: September 5, 2023
• Primary Completion: January 20, 2025
• Study Completion: March 5, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)