The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment.
NCT ID: NCT07166224
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2025-10-31
2028-12-31
Brief Summary
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To compare three different oral hygiene regimens regarding plaque index (PI), bleeding on probing (BOP), the number of deepened periodontal pockets ≥4 mm (PPD), oral halitosis, and changes in oral health-related quality of life (OHRQoL) in an older population with periodontitis stage I-III and mild cognitive impairment.
1. Are there improvements in plaque index (PI), number of bleeding on probing (BOP) sites, number of probing depths (PPD), and intraoral halitosis in the two test groups compared to the control group?
2. Do the study interventions affect oral health-related quality of life in older adults with periodontitis and mild cognitive impairment?
Study design:
Type: Randomized controlled trial Duration: 6 months per participant, 2 years in total for data collection Participants: 90 participants divided into Intervention and Control groups
Intervention Group A (Lumoral Dual-Light aPDT + Manual Toothbrush) Standardized oral hygiene instructions and the use of a manual toothbrush during the test period, with an adjunctive aPDT device (Lumoral®).
Intervention Group B (Oral-B iO Powered Toothbrush) Standardized oral hygiene instructions and the use of an Oral-B iO powered toothbrush during the test period.
Control Group Standardized oral hygiene instructions and the use of a manual TePe Select extra soft toothbrush during the test period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Partisipants with Lumoral Dual-Light aPDT + Manual Toothbrush
Dual-Light aPDT Treatment - Lumoral
Intervention Group A:
Participants receive standardized oral hygiene instructions and use only a manual toothbrush during the test period, with the addition of an adjunctive antimicrobial photodynamic therapy (aPDT) device (Lumoral®).
The Lumoral® treatment device is a CE-marked antibacterial device intended for home use. It is designed to support the treatment and prevention of oral diseases caused by bacterial biofilms. The device functions by emitting light at a specific wavelength, which activates a CE-marked photosensitizing mouthrinse, Lumorinse®. This light-activated process enhances antibacterial efficacy, targeting pathogenic microorganisms in the oral cavity and supporting improved oral hygiene outcomes.
Partisipants with Oral-B iO Powered Toothbrush
Oral-B Powered toothbrush
Intervention Group B:
Participants receive standardized oral hygiene instructions and use an Oral-B iO powered toothbrush during the test period.
The Oral-B iO is an advanced powered toothbrush that combines oscillating-rotating and micro-vibrating bristle movements with real-time feedback technology. It is CE-marked for home use and designed to improve plaque removal and overall oral hygiene compared to manual toothbrushing. The device incorporates pressure sensors and guided brushing modes to support optimal brushing technique and patient adherence, which may contribute to improved periodontal outcomes.
Control Group
No interventions assigned to this group
Interventions
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Oral-B Powered toothbrush
Intervention Group B:
Participants receive standardized oral hygiene instructions and use an Oral-B iO powered toothbrush during the test period.
The Oral-B iO is an advanced powered toothbrush that combines oscillating-rotating and micro-vibrating bristle movements with real-time feedback technology. It is CE-marked for home use and designed to improve plaque removal and overall oral hygiene compared to manual toothbrushing. The device incorporates pressure sensors and guided brushing modes to support optimal brushing technique and patient adherence, which may contribute to improved periodontal outcomes.
Dual-Light aPDT Treatment - Lumoral
Intervention Group A:
Participants receive standardized oral hygiene instructions and use only a manual toothbrush during the test period, with the addition of an adjunctive antimicrobial photodynamic therapy (aPDT) device (Lumoral®).
The Lumoral® treatment device is a CE-marked antibacterial device intended for home use. It is designed to support the treatment and prevention of oral diseases caused by bacterial biofilms. The device functions by emitting light at a specific wavelength, which activates a CE-marked photosensitizing mouthrinse, Lumorinse®. This light-activated process enhances antibacterial efficacy, targeting pathogenic microorganisms in the oral cavity and supporting improved oral hygiene outcomes.
Eligibility Criteria
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Inclusion Criteria
* ≥15 teeth
* Diagnosed periodontitis stage I-III
* MMSE score between 22-28
* Able to provide informed consent
Exclusion Criteria
* Lumoral use within 3 months
* Bisphosphonate medication
* Immunosuppressive drugs or radiation therapy
60 Years
ALL
No
Sponsors
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Blekinge Institute of Technology
OTHER
Responsible Party
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Locations
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Blekinge Tekniska Högskola
Karlskrona, Blekinge County, Sweden
Countries
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Facility Contacts
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Other Identifiers
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BTH-6.1.1-0172-2025
Identifier Type: -
Identifier Source: org_study_id
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