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. (e-DENT II)

Blekinge Institute of Technology

Status: Not yet enrolling

Conditions: Oral Halitosis; Periodontal Diseases

Treatments: Device: Oral-B Powered toothbrush; Device: Dual-Light aPDT Treatment - Lumoral

Study type: Interventional

Funder types: Other

Identifiers

NCT07166224

BTH-6.1.1-0172-2025

Details and patient eligibility

About

Objective:

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged ≥60 years
• ≥15 teeth
• Diagnosed periodontitis stage I-III
• MMSE score between 22-28
• Able to provide informed consent

Exclusion criteria

• Antibiotic use (within 3 months)
• Lumoral use within 3 months
• Bisphosphonate medication
• Immunosuppressive drugs or radiation therapy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Partisipants with Lumoral Dual-Light aPDT + Manual Toothbrush

Experimental group

Treatment:

Device: Dual-Light aPDT Treatment - Lumoral

Partisipants with Oral-B iO Powered Toothbrush

Experimental group

Treatment:

Device: Oral-B Powered toothbrush

Control Group

No Intervention group