search
Back to results

Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis

Primary Purpose

Periodontitis Chronic Generalized Moderate, Periodontitis Chronic Generalized Severe

Status
Recruiting
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Lumoral Treatment
Sponsored by
Koite Health Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis Chronic Generalized Moderate focused on measuring Lumoral, Lumorinse, Periodontitis, Anti-bacterial photodynamic therapy, aPDT, Plaque, aMMP-8, Photobiomodulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Periodontal disease stage III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss. ≥ 18 years old Presence of ≥20 teeth, including implants Agreement to participate in the study and to sign a written consent form Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol Exclusion Criteria: Grade A or C periodontitis Presence of any physical limitation or restriction that might restrict Lumoral use Pregnancy or lactation Active smoking Medicated diabetes mellitus (DM) Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease Use of antibiotics within 4 weeks week prior study Periodontal treatment within 3 months prior study Removable major prosthesis or major orthodontic appliance A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment

Sites / Locations

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control group

Arm Description

A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.

A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.

Outcomes

Primary Outcome Measures

Bleeding on probing (BOP)
Improvement 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

Secondary Outcome Measures

Active matrix metalloproteinase 8 (aMMP-8)
Change in periodontal inflammation marker aMMP-8
Visible plaque index (VPI)
Change in visible plaque index (VPI)
Probing pocket depth (PPD)
Change in probing pocket depth (PPD)
Clinical attachment level (CAL)
Change in clinical attachment level (CAL)
Deep periodontal pockets (over 4 mm)
Change in the number of deep periodontal periodontal pockets (over 4 mm)
Periodontal microbiological flora
Change in periodontal microbiological flora during the study period
Additional visits
Number of additional visits due to periodontitis status between 2nd and 3rd follow-up visits
OHIP-14
Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire

Full Information

First Posted
January 16, 2023
Last Updated
June 6, 2023
Sponsor
Koite Health Oy
Collaborators
University of Helsinki, Lithuanian University of Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT05698823
Brief Title
Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis
Official Title
Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

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

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 in chronic periodontitis with a targeted group of stage III and IV periodontitis. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the method might have a photobiomodulation effect on periodontal tissues.
Detailed Description
The Lumoral Treatment 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 specially designed mouth rinse that strongly adheres to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown promising anti-inflammatory responses in addition to plaque reduction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis Chronic Generalized Moderate, Periodontitis Chronic Generalized Severe
Keywords
Lumoral, Lumorinse, Periodontitis, Anti-bacterial photodynamic therapy, aPDT, Plaque, aMMP-8, Photobiomodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
All clinical assessments at baseline and at 6 months shall be performed by one calibrated examiner who is blinded for the subjects' allocation to the study and control groups.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.
Intervention Type
Device
Intervention Name(s)
Lumoral Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bleeding on probing (BOP)
Description
Improvement 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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Active matrix metalloproteinase 8 (aMMP-8)
Description
Change in periodontal inflammation marker aMMP-8
Time Frame
6 months
Title
Visible plaque index (VPI)
Description
Change in visible plaque index (VPI)
Time Frame
6 months
Title
Probing pocket depth (PPD)
Description
Change in probing pocket depth (PPD)
Time Frame
6 months
Title
Clinical attachment level (CAL)
Description
Change in clinical attachment level (CAL)
Time Frame
6 months
Title
Deep periodontal pockets (over 4 mm)
Description
Change in the number of deep periodontal periodontal pockets (over 4 mm)
Time Frame
6 months
Title
Periodontal microbiological flora
Description
Change in periodontal microbiological flora during the study period
Time Frame
6 months
Title
Additional visits
Description
Number of additional visits due to periodontitis status between 2nd and 3rd follow-up visits
Time Frame
6 months
Title
OHIP-14
Description
Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Device-related adverse event
Description
Absence of device-related serious adverse events or any patterns of device-related adverse events graded as moderate
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Periodontal disease stage III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss. ≥ 18 years old Presence of ≥20 teeth, including implants Agreement to participate in the study and to sign a written consent form Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol Exclusion Criteria: Grade A or C periodontitis Presence of any physical limitation or restriction that might restrict Lumoral use Pregnancy or lactation Active smoking Medicated diabetes mellitus (DM) Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease Use of antibiotics within 4 weeks week prior study Periodontal treatment within 3 months prior study Removable major prosthesis or major orthodontic appliance A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikko Kylmänen, Bachelor
Phone
+358407245934
Email
mikko.kylmanen@koitehealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timo Sorsa, Professor
Organizational Affiliation
University of Helsinki
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tommi Pätilä, Docent
Organizational Affiliation
Koite Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ingrida Marija Pacauskiene, Doctor
Organizational Affiliation
Lithuanian University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
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
Ingrida Marija Pacauskiene, Doctor
First Name & Middle Initial & Last Name & Degree
Nomeda Basevičienė, Doctor
First Name & Middle Initial & Last Name & Degree
Vita Mačiulskienė, Professor
First Name & Middle Initial & Last Name & Degree
Raimonda Guntulytė, Doctor
First Name & Middle Initial & Last Name & Degree
Alma Pranckevičienė, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The IPD will only be administered by the researchers that are listed in the CIP.
Citations:
PubMed Identifier
25261053
Citation
Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.
Results Reference
background
PubMed Identifier
28792274
Citation
Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.
Results Reference
background
PubMed Identifier
25496279
Citation
Lang NP, Suvan JE, Tonetti MS. Risk factor assessment tools for the prevention of periodontitis progression a systematic review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S59-70. doi: 10.1111/jcpe.12350.
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
9332805
Citation
Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
Results Reference
background
Links:
URL
https://doi.org/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://doi.org/10.1590/S1806-83242014.50000004
Description
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
URL
https://www.fda.gov/media/75892/download
Description
Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.
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): e0232775
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
http://dx.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

Learn more about this trial

Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis

We'll reach out to this number within 24 hrs