Prevention of Dental Implant Diseases

Not Applicable

Completed

• Conditions: Peri-Implantitis
• Interventions: Other: Standard treatment for peri-implantitis; Device: Lumoral Treatment

• Registration Number: NCT05871229
• Lead Sponsor: Hanna Lähteenmäki

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.

Study Timeline

• Study Start: 2023-01-13
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-23
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standard treatment for peri-implantitis	Standard treatment only
Study group	Standard treatment for peri-implantitis	Lumoral and standard treatment
Study group	Lumoral Treatment	Lumoral and standard treatment

Primary Outcome Measures

Name	Time	Method
Active matrix metalloproteinase 8 (aMMP-8)	30 days	Change in periodontal inflammation marker aMMP-8

Secondary Outcome Measures

Name	Time	Method
Bleeding on probing (BOP)	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
Visible plaque index (VPI)	30 days	Change in visible plaque index

Trial Locations

Locations (1)

Hammasklinikka Kruunu Oy; 🇫🇮 Tampere, Pirkanmaa, Finland