Clinical trial NCT05871229: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Keywords: Peri-implant disease
aMMP-8
Antibacterial photodynamic therapy (aBPT)
Oral hygiene
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: University of Helsinki
name: Koite Health Oy
name: Hammasklinikka Kruunu
First posted: 2023-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Active matrix metalloproteinase 8 (aMMP-8)
timeFrame: 30 days
Secondary outcomes:
measure: Bleeding on probing (BOP)
timeFrame: 30 days
measure: Visible plaque index (VPI)
timeFrame: 30 days
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Hammasklinikka Kruunu Oy
state: Pirkanmaa
Study officials:
affiliation: Hammasklinikka Kruunu
name: Hanna Lähteenmäki, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sorsa T, Gieselmann D, Arweiler NB, Hernandez M. A quantitative point-of-care test for periodontal and dental peri-implant diseases. Nat Rev Dis Primers. 2017 Sep 14;3:17069. doi: 10.1038/nrdp.2017.69. No abstract available.
citation: Sorsa T, Hernandez M, Leppilahti J, Munjal S, Netuschil L, Mantyla P. Detection of gingival crevicular fluid MMP-8 levels with different laboratory and chair-side methods. Oral Dis. 2010 Jan;16(1):39-45. doi: 10.1111/j.1601-0825.2009.01603.x. Epub 2009 Jul 8.
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citation: Suarez-Lopez Del Amo F, Yu SH, Wang HL. Non-Surgical Therapy for Peri-Implant Diseases: a Systematic Review. J Oral Maxillofac Res. 2016 Sep 9;7(3):e13. doi: 10.5037/jomr.2016.7313. eCollection 2016 Jul-Sep.
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