Prevention of Dental Implant Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Dental Implant Diseases: Early Diagnosis and Monitoring in Clinical Work and Enhanced Oral Health Maintenance at Home

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Device: Lumoral Treatment
* Other: Standard treatment for peri-implantitis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Lumoral and standard treatment | Device: Lumoral Treatment<br>* Photodynamic antibacterial dual-light device with a marker substance<br>Other: Standard treatment for peri-implantitis<br>* Standard treatment for peri-implantitis as per international, national and clinic guidelines<br>|
| Other: Control group<br>Standard treatment only | Other: Standard treatment for peri-implantitis<br>* Standard treatment for peri-implantitis as per international, national and clinic guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active matrix metalloproteinase 8 (aMMP-8) | Change in periodontal inflammation marker aMMP-8 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 
| Visible plaque index (VPI) | Change in visible plaque index | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peri-implant disease, Antibacterial photodynamic therapy (aBPT), Oral hygiene, aMMP-8