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OpenTrials
Completed

NCT Number: NCT05871229

Prevention of Dental Implant Diseases

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammasklinikka Kruunu Oy

Tampere, Pirkanmaa, 33200, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumoral Treatment

Device

Photodynamic antibacterial dual-light device with a marker substance

Standard treatment for peri-implantitis

Other

Standard treatment for peri-implantitis as per international, national and clinic guidelines

Primary outcomes

  1. Active matrix metalloproteinase 8 (aMMP-8)

    Time frame: 30 days

    Change in periodontal inflammation marker aMMP-8

Secondary outcomes

  1. Bleeding on probing (BOP)

    Time frame: 30 days

    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

  2. Visible plaque index (VPI)

    Time frame: 30 days

    Change in visible plaque index

Sponsors and collaborators

Lead sponsor

Hanna Lähteenmäki

Industry

Collaborators

  • Hammasklinikka Kruunu
  • Koite Health Oy
  • University of Helsinki

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 23, 2023
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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