Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
NCT ID: NCT06017817
Last Updated: 2024-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-05-13
2026-12-31
Brief Summary
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Detailed Description
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Matrix metalloproteinase 8 (MMP-8) has been found to be elevated in association with oral infections, such as periodontitis and peri-implantitis. The level of active MMP-8 (aMMP-8) can detect to determine tissue health and to assess inflammation, and can easily be measured during a regular dental appointment with a chairside test.
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 method mechanism of action is antibacterial photodynamic therapy (aPDT). The method 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
After the randomization, there is no masking.
Study Groups
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Non-surgical treatment, Study group (NST-1)
Lumoral Treatment; Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
Lumoral Treatment
Anti-infective photodynamic therapy for plaque-induced oral conditions
Standard oral hygiene instructions
Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use
Scaling and root planing (SRP
non-surgical anti-infective treatment by scaling and root planing
Non-surgical treatment, Control group (NST-2)
Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
Standard oral hygiene instructions
Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use
Scaling and root planing (SRP
non-surgical anti-infective treatment by scaling and root planing
Surgical treatment, Study group (ST-1)
Lumoral Treatment; Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
Lumoral Treatment
Anti-infective photodynamic therapy for plaque-induced oral conditions
Standard oral hygiene instructions
Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use
surgical anti-infective peri-implantitis treatment
surgical anti-infective peri-implantitis treatment
Surgical treatment, Control group (ST-2)
Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.
Standard oral hygiene instructions
Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use
surgical anti-infective peri-implantitis treatment
surgical anti-infective peri-implantitis treatment
Interventions
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Lumoral Treatment
Anti-infective photodynamic therapy for plaque-induced oral conditions
Standard oral hygiene instructions
Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use
Scaling and root planing (SRP
non-surgical anti-infective treatment by scaling and root planing
surgical anti-infective peri-implantitis treatment
surgical anti-infective peri-implantitis treatment
Eligibility Criteria
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Inclusion Criteria
* Dental implants collected and clinically characterized according to Lähteenmäki et al. CEDR-22
* 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
* Unwilling to participate in the study
* Pregnancy or lactation
* Active smoking
* Medicated diabetes mellitus (DM)
* Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of peri-implantitis
* Use of antibiotics and doxycycline, chlorhexidine, and bisphosphonates, within 4 weeks week prior to study participation
* Peri-implant and periodontal treatment within 3 months prior to study participation
* Removable major prosthesis or major orthodontic appliance
18 Years
85 Years
ALL
No
Sponsors
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University of Helsinki
OTHER
Nilminie Rathnayake
INDUSTRY
Responsible Party
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Nilminie Rathnayake
Principal Investigator
Principal Investigators
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Nilminie Rathnayake, Assoc Prof
Role: PRINCIPAL_INVESTIGATOR
University of Helsinki
Locations
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Södertandläkarna AB
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Nilminie Rathnayake, Periodontist
Role: primary
References
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Berglundh T, Jepsen S, Stadlinger B, Terheyden H. Peri-implantitis and its prevention. Clin Oral Implants Res. 2019 Feb;30(2):150-155. doi: 10.1111/clr.13401. Epub 2019 Feb 3.
Jepsen S, Berglundh T, Genco R, Aass AM, Demirel K, Derks J, Figuero E, Giovannoli JL, Goldstein M, Lambert F, Ortiz-Vigon A, Polyzois I, Salvi GE, Schwarz F, Serino G, Tomasi C, Zitzmann NU. Primary prevention of peri-implantitis: managing peri-implant mucositis. J Clin Periodontol. 2015 Apr;42 Suppl 16:S152-7. doi: 10.1111/jcpe.12369.
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.
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.
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.
Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. 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. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.
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.
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.
Related Links
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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)
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
Levine JI. Medications that increase photosensitivity. FDA document Dec 1990.
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
Other Identifiers
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HEALTHIER
Identifier Type: -
Identifier Source: org_study_id
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