Prevention of Dental Implant Diseases
Primary Purpose
Peri-Implantitis
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Lumoral Treatment
Standard treatment for peri-implantitis
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis focused on measuring Peri-implant disease, aMMP-8, Antibacterial photodynamic therapy (aBPT), Oral hygiene
Eligibility Criteria
Inclusion Criteria: One or more dental implants Diagnosis of peri-implantitis Challenges in keeping high self-care oral care standards Over 25 years of age Exclusion Criteria: - Any antibiotic medication within 6 months prior to study participation
Sites / Locations
- Hammasklinikka Kruunu Oy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Study group
Control group
Arm Description
Lumoral and standard treatment
Standard treatment only
Outcomes
Primary Outcome Measures
Active matrix metalloproteinase 8 (aMMP-8)
Change in periodontal inflammation marker aMMP-8
Secondary 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
Visible plaque index (VPI)
Change in visible plaque index
Full Information
NCT ID
NCT05871229
First Posted
May 3, 2023
Last Updated
August 8, 2023
Sponsor
Hanna Lähteenmäki
Collaborators
University of Helsinki, Koite Health Oy, Hammasklinikka Kruunu
1. Study Identification
Unique Protocol Identification Number
NCT05871229
Brief Title
Prevention of Dental Implant Diseases
Official Title
Prevention of Dental Implant Diseases: Early Diagnosis and Monitoring in Clinical Work and Enhanced Oral Health Maintenance at Home
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
July 14, 2023 (Actual)
Study Completion Date
July 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hanna Lähteenmäki
Collaborators
University of Helsinki, Koite Health Oy, Hammasklinikka Kruunu
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
The aim of this study is to determine the effect of regular antibacterial photodynamic Lumoral® treatment on gingival health and plaque volume, and anti-inflammatory effect of daily double light therapy on implant teeth. The study will use a medical device containing a light-activated Lumorinse® mouthwash and a Lumoral® light activator.
Detailed Description
The hypothesis is that antibacterial photodynamic therapy improves tissue health by reducing inflammation without any side effect.
Study participants will be invited from a dental clinic in Tampere, Finland, from the patients of an oral hygienist's office. Participants will be randomized to the treatment and control groups using the closed envelope method. Participants in the treatment group will receive Lumoral® treatment according to the manufacturer's protocol, once daily for 10 min for 15 days and then twice daily for 15 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
Peri-implant disease, aMMP-8, Antibacterial photodynamic therapy (aBPT), Oral hygiene
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
ParticipantInvestigator
Masking Description
Participants will be randomized at the end of baseline visit
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Lumoral and standard treatment
Arm Title
Control group
Arm Type
Other
Arm Description
Standard treatment only
Intervention Type
Device
Intervention Name(s)
Lumoral Treatment
Intervention Description
Photodynamic antibacterial dual-light device with a marker substance
Intervention Type
Other
Intervention Name(s)
Standard treatment for peri-implantitis
Intervention Description
Standard treatment for peri-implantitis as per international, national and clinic guidelines
Primary Outcome Measure Information:
Title
Active matrix metalloproteinase 8 (aMMP-8)
Description
Change in periodontal inflammation marker aMMP-8
Time Frame
30 days
Secondary 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
30 days
Title
Visible plaque index (VPI)
Description
Change in visible plaque index
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
One or more dental implants
Diagnosis of peri-implantitis
Challenges in keeping high self-care oral care standards
Over 25 years of age
Exclusion Criteria:
- Any antibiotic medication within 6 months prior to study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Lähteenmäki, Doctor
Organizational Affiliation
Hammasklinikka Kruunu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammasklinikka Kruunu Oy
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33200
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24428439
Citation
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Results Reference
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Citation
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Citation
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Citation
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Links:
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Description
Alassiri, S. et al. (2018). The Ability of Quantitative, Specific, and Sensitive Point-of-Care/Chair-Side Oral Fluid Immunotests for aMMP-8 to Detect Periodontal and Peri-Implant Diseases. Disease Markers
URL
https://www.mdpi.com/2304-6767/7/1/9
Description
Emingil, G. et al. (2019). Adjunctive effects of a sub-antimicrobial dose of doxycycline on clinical parameters and potential biomarkers of periodontal tissue catabolism. Dentistry Journal, 7(1)
URL
https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/32084
Description
Hentilä, J. et al. (2021). Dual-Light Photodynamic Therapy Effectively Eliminates Streptococcus Oralis Biofilms. Journal of Pharmacy & Pharmaceutical Sciences, 24
URL
https://www.nature.com/articles/sj.bdj.2016.865
Description
Kilian, M. et al. (2016). The oral microbiome - An update for oral healthcare professionals. British Dental Journal, 221(10).
URL
https://link.springer.com/article/10.1007/s00011-013-0704-2
Description
Kormi, I et al. (2014) The effect of prolonged systemic doxycycline therapy on serum tissue degrading proteinases in coronary bypass patients: a randomized, double-masked, placebo-controlled clinical trial. Inflammation Research, 63(5), 329-334
URL
https://www.mdpi.com/1467-3045/44/3/85
Description
Lähteenmäki, H. et al. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Current Issues in Molecular Biology 2022, Vol. 44, Pages 1273-1283.
URL
https://doi.org/10.3390/jcm8020279
Description
Monje, A., Insua, A., & Wang, H.-L. (2019). Understanding Peri-Implantitis as a Plaque-Associated and Site-Specific Entity: On the Local Predisposing Factors. Journal of Clinical Medicine, 8(2), 279.
URL
https://doi.org/10.1371/journal.pone.0232775
Description
Nikinmaa, S., 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/dj9050052
Description
Nikinmaa, S. et al. (2021) Indocyanine green-assisted and led-light-activated antibacterial photodynamic therapy reduces dental plaque. Dentistry Journal, 9(5).
URL
https://doi.org/10.3390/antibiotics10101240
Description
Nikinmaa, S. et al. (2021) Daily administered dual-light photodynamic therapy provides a sustained antibacterial effect on staphylococcus aureus. Antibiotics, 10(10).
URL
https://doi.org/10.3390/microorganisms8050661
Description
Sahrmann, P., Gilli, F., Wiedemeier, D. B., Attin, T., Schmidlin, P. R., & Karygianni, L. (2020). The Microbiome of Peri-Implantitis: A Systematic Review and Meta-Analysis. Microorganisms (Basel), 8(5), 661
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Prevention of Dental Implant Diseases
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