Prevention of Dental Implant Diseases

August 8, 2023 updated by: Hanna Lähteenmäki, Hanna Lahteenmaki

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33200
        • Hammasklinikka Kruunu Oy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanna Lahteenmaki

Collaborators

University of Helsinki
Koite Health Oy
Hammasklinikka Kruunu

Investigators

  • Principal Investigator: Hanna Lähteenmäki, Doctor, Hammasklinikka Kruunu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2023

Primary Completion (Actual)

July 14, 2023

Study Completion (Actual)

July 14, 2023

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IS-TRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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