Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis
Study Details
Study Description
Brief Summary
This early-stage research is designed to determine the efficacy of the Lumoral method in chronic 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque.
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. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lumoral Treatment (Study group) Subjects will receive detailed instructions for the use of Lumoral treatment -device and Lumorinse -tablets. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol five to seven (5-7) times a week. Regular use shall be defined as frequency of a minimum of twice a week. Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects. |
Device: Lumoral treatment
The investigational Lumoral treatment -device provides a constant and repeatable application which can be done at home and is easily available. All subjects in the study group will receive their own Lumoral treatment -device and Lumorinse-mouth rinse tablets for the complete duration of the study.
Other Names:
Other: Standard oral hygiene self care
Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.
Other Names:
|
| Active Comparator: Standard of care (Control group) Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects. |
Other: Standard oral hygiene self care
Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Reduction in dental inflammation [3 months]
Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 3 months compared to baseline
- Reduction in dental inflammation [6 months]
Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 6 months compared to baseline
- Stabilization of the periodontal disease [3 months]
Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 3 months compared to baseline
- Stabilization of the periodontal disease [6 months]
Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 6 months compared to baseline
Secondary Outcome Measures
- Reduction in aMMP-8 measurement [3 months]
Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 3 months compared to baseline
- Reduction in aMMP-8 measurement [6 months]
Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 6 months compared to baseline
- Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status [3 months]
Clinical improvement of periodontitis measured by probing pocket depth (PPD) at 3 months based on the absolute values of PPD. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
- Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status [6 months]
Clinical improvement of periodontitis measured by probing pocket depth (PPD) at 6 months based on the absolute values of PPD. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
- Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status [3 months]
Clinical improvement of periodontitis measured by clinical attachment level (CAL) at 3 months based on the absolute values of CAL. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
- Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status [6 months]
Clinical improvement of periodontitis measured by clinical attachment level (CAL) at 6 months based on the absolute values of CAL. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
- Change in periodontal microbiological pathogens. [3 months]
Clinical improvement in periodontal microbiological pathogens at 3 months compared to baseline. The microbiological evaluation is the Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis. Microbiological sample will be collected using so called Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points will then be be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis.
- Change in periodontal microbiological pathogens. [6 months]
Clinical improvement in periodontal microbiological pathogens at 6 months compared to baseline. The microbiological evaluation is the Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis. Microbiological sample will be collected using so called Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points will then be be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis.
- Improvement in oral-related quality of life. [3 months]
Patient related objectives: Improvement in oral-related quality of life measurement (OHIP-14) questionnaire at baseline, at 3 months compared to baseline. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'.
- Improvement in oral-related quality of life. [6 months]
Patient related objectives: Improvement in oral-related quality of life measurement (OHIP-14) questionnaire at baseline, at 6 months compared to baseline. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Periodontal disease stage I-III, according to criteria the American Academy of Periodontology (AAP) with at least 2 mm interdental CAL in the site of greatest loss.
-
Age of 18- 85 years
-
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:
-
Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
-
Removable major prosthesis or major orthodontic appliance
-
Pregnancy or lactation
-
Use of antibiotics within 2 weeks prior the study
-
A need for immediate antimicrobial treatment for periodontitis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mehiläinen Länsi-Pohja Central Hospital | Kemi | Lappi | Finland | 94100 |
| 2 | Terveystalo | Oulu | Finland | 90100 | |
| 3 | City of Rovaniemi Health Cervices, Oral Health | Rovaniemi | Finland | 96100 |
Sponsors and Collaborators
- Koite Health Oy
- University of Helsinki
- University of Oulu
- Terveystalo
- Mehiläinen Länsi-Pohja Central Hospital
- City of Rovaniemi Health Care Services
Investigators
- Study Director: Tommi Pätilä, Docent, Head of Research
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review.
- Joshi K, Baiju CS, Khashu H, Bansal S (2020) 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.
- Kassebaum NJ, Bernabé E, Dahiya M et al., (2014) Global burden of severe periodontitis in 1990- 2010: a systematic review and meta-regression.
- Kassebaum NJ, Smith AGC, Bernabé E, et al., (2017) 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
- Lang NP, Suvan JE, Tonetti MS (2015) Risk factor assessment tools for the prevention of periodontitis progression a systematic review.
- Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.
- Loos BG & Needleman I (2020) Endpoints of active periodontal therapy.
- 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.
- Monzavi A, Chinipardaz Z, Mousavi M, et al., (2016) Antimicrobial photodynamic therapy using diode laser activated indocyanine green as an adjunct in the treatment of chronic periodontitis: A randomized clinical trial.
- 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.
- 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.
- Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease.
- 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.
- Schär D, Ramseier CA, Eick S, et al., (2020) Transgingival photodynamic therapy (tg-aPDT) adjunctive to subgingival mechanical instrumentation in supportive periodontal therapy. A randomized controlled clinical study.
- Slade GD (1997) Derivation and validation of a short-form oral health impact profile
Publications
None provided.- LumoNorth2022