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

Primary Purpose

Orthodontic Appliance Complication, Plaque, Dental, Gingival Inflammation

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lumoral Treatment
Standard oral health instructions
Sponsored by
Koite Health Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthodontic Appliance Complication

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Borgska Villans SpecialisttandvårdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Lumoral Treatment (Study group)

Standard of care (Control group)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Bleeding on probing (BOP)
A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) 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 is reported as the percentage (%) of sites with positive findings. Calculation formula: number of bleeding sites/ 6 times number of teeth
Change in Orthodontic plaque index (OPI)
The OPI indicates the presence of plaque around the multibracket appliance after staining the teeth with a plaque-disclosing solution. Using the data from the digital photographs, selected six (6) index teeth that bear an adhesively bonded bracket will be evaluated. The status is indicated as a score from 0 to 4. The degree of plaque accumulation on each aspect of the bracket base and the condition of the adjacent marginal gingivae are assessed: 0 = No plaque deposits on the tooth surfaces surrounding the bracket base = Plaque deposits on one tooth surface at the bracket base = Plaque deposits on two tooth surfaces at the bracket base = Plaque deposits on three tooth surfaces at the bracket base = Plaque deposits on four tooth surfaces at the bracket base and/or gingival inflammation indicators (plaque deposits near the gingiva do not necessarily have to be present)
Change in periodontal microbiological flora
Microbiological sampling and analysis: Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis. Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from the plaque on the surface of the teeth, using a curette if needed. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis. 16S rRNA sequencing can be performed at a qualified laboratory assigned by the study sponsor

Full Information

First Posted
April 11, 2023
Last Updated
September 8, 2023
Sponsor
Koite Health Oy
Collaborators
University of Helsinki, Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05825742
Brief Title
Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment
Official Title
Efficacy of Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment - Randomized, Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koite Health Oy
Collaborators
University of Helsinki, Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Orthodontic treatment is one of the most common dental treatments in children and adolescents. The use of fixed orthodontic appliances makes it difficult for the patients to keep their oral hygiene to an optimum level of cleanliness. Poor oral hygiene attracts significant plaque accumulation around the fixed orthodontic treatment appliances, and subsequent white spot lesions can occur rapidly, usually on the cervical and middle third of the buccal surfaces of bracketed teeth. Patients with the fixed orthodontic treatment appliances have an increased risk of caries and gingivitis. 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 (aPDT). 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. Forty (40) subjects undergoing fixed orthodontic treatment are randomized to the Lumoral treatment group or the control group. All subjects shall receive polishing and oral hygiene instruction. All patients shall be assessed for the clinical measurements including visible plaque index (VPI), bleeding on probing (BOP), and orthodontic plaque index (OPI) at baseline and at 4 weeks and 12 weeks after baseline. In addition, microbiological analyses shall be performed at baseline and at 12 weeks after baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Appliance Complication, Plaque, Dental, Gingival Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
The participants, care providers, and investigators shall be masked before the first measurements. The randomization will be conducted after the first measurements.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumoral Treatment (Study group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care (Control group)
Arm Type
Other
Arm Description
Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.
Intervention Type
Device
Intervention Name(s)
Lumoral Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard oral health instructions
Intervention Description
Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.
Primary Outcome Measure Information:
Title
Change in Visible plaque index (VPI)
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Bleeding on probing (BOP)
Description
A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) 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 is reported as the percentage (%) of sites with positive findings. Calculation formula: number of bleeding sites/ 6 times number of teeth
Time Frame
12 weeks
Title
Change in Orthodontic plaque index (OPI)
Description
The OPI indicates the presence of plaque around the multibracket appliance after staining the teeth with a plaque-disclosing solution. Using the data from the digital photographs, selected six (6) index teeth that bear an adhesively bonded bracket will be evaluated. The status is indicated as a score from 0 to 4. The degree of plaque accumulation on each aspect of the bracket base and the condition of the adjacent marginal gingivae are assessed: 0 = No plaque deposits on the tooth surfaces surrounding the bracket base = Plaque deposits on one tooth surface at the bracket base = Plaque deposits on two tooth surfaces at the bracket base = Plaque deposits on three tooth surfaces at the bracket base = Plaque deposits on four tooth surfaces at the bracket base and/or gingival inflammation indicators (plaque deposits near the gingiva do not necessarily have to be present)
Time Frame
12 weeks
Title
Change in periodontal microbiological flora
Description
Microbiological sampling and analysis: Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis. Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from the plaque on the surface of the teeth, using a curette if needed. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis. 16S rRNA sequencing can be performed at a qualified laboratory assigned by the study sponsor
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikko Kylmänen
Phone
+358407245934
Email
mikko.kylmanen@koitehealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Marie Roos Jansåker, Professor
Organizational Affiliation
Borgska Villans Specialisttandvård
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tommi Pätilä, Docent
Organizational Affiliation
Koite Health
Official's Role
Study Director
Facility Information:
Facility Name
Borgska Villans Specialisttandvård
City
Lund
ZIP/Postal Code
22355
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikko Kylmänen
Phone
+358407245934
Email
mikko.kylmanen@koitehealth.com
First Name & Middle Initial & Last Name & Degree
Ann-Marie Roos Jansåker, Professor
First Name & Middle Initial & Last Name & Degree
Katja Elses, DDS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30935601
Citation
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.
Results Reference
background
PubMed Identifier
34063662
Citation
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.
Results Reference
background
PubMed Identifier
29114647
Citation
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.
Results Reference
background
PubMed Identifier
31144319
Citation
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.
Results Reference
background
Links:
URL
https://link.springer.com/article/10.1007/s41547-019-00056-9
Description
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)
URL
https://www.fda.gov/media/75892/download
Description
Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.
URL
https://bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-019-0828-z
Description
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
URL
https://doi.org/10.3390/cimb44030085
Description
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. Curr. Issues Mol. Biol. 44,1273-1283
URL
https://doi.org/10.1371/journal.pone.0232775
Description
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)
URL
https://doi.org/10.3390/antibiotics10101240
Description
Nikinmaa S, Podonyi A, Raivio P, et al. (2021b). Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus. Antibiotics, 10 (10): 1240
URL
https://doi.org/10.1016/j.parkreldis.2017.02.026
Description
Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease. Parkinsonism and Related Disorders 38: 61-67

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

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