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.

NCT07166224 | Not Yet Recruiting

• 1 other identifier: BTH-6.1.1-0172-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Do the study interventions affect oral health-related quality of life in older adults with periodontitis and mild cognitive impairment?

Conditions

Periodontal Diseases; Oral Halitosis

Keywords

Mild Cognitive Impairment; Oral health; Quality of life; Powered toothbrush

Outcome Measures

Primary Outcomes (6)

• Change in the amount of dental plaque

  Assessment will be performed on all teeth at six sites per tooth. The plaque index (PI) will be reported as the percentage of sites with visible plaque, providing an estimate of the overall plaque accumulation on the teeth.

  Assessments will be conducted at baseline, at 3 months, and at 6 months.

• Change in the amount of gingival bleeding on probing

  A full-mouth assessment will be performed at six sites per tooth. Bleeding on probing (BOP) will be reported as the percentage of sites exhibiting bleeding.

  Assessments will be conducted at baseline, at 3 months, and at 6 months.

• Change in the number of periodontal pockets ≥4 mm in depth

  Pocket depth will be measured from the base of the pocket to the gingival margin at six sites per tooth. Probing pocket depths (PPD) of ≥4 mm will be recorded.

  Assessments will be conducted at baseline, at 3 months, and at 6 months.

• MMSE-test

  An 11-item cognitive assessment covering five domains: orientation, registration, attention and calculation, recall, and language. The maximum possible score is 30, with a score of 23 or lower indicating cognitive impairment.

  Baseline

• Change in the amount of VSCs in the exhaled air

  Volatile sulfur compounds (VSCs) in exhaled air will be measured using the OralChroma® device. The cutoff values are as follows: H₂S ≥112 ppb, CH₃SH ≥26 ppb, and (CH₃)₂S ≥8 ppb.

  Assessments will be conducted at baseline, at 3 months, and at 6 months.

• Change in values for the oral health related quality of life instrument OHIP-14

  Oral health-related quality of life will be assessed using the OHIP-14 (Oral Health Impact Profile-14) instrument. Scores range from 0 to 56, with lower scores indicating better oral health-related quality of life.

  Assessments will be conducted from baseline to 6 months.

Study Arms (3)

Partisipants with Lumoral Dual-Light aPDT + Manual Toothbrush

EXPERIMENTAL

Device: Dual-Light aPDT Treatment - Lumoral

Partisipants with Oral-B iO Powered Toothbrush

EXPERIMENTAL

Device: Oral-B Powered toothbrush

Control Group

NO INTERVENTION

Interventions

Oral-B Powered toothbrush DEVICE

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.

Partisipants with Oral-B iO Powered Toothbrush

Dual-Light aPDT Treatment - Lumoral DEVICE

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 Lumoral Dual-Light aPDT + Manual Toothbrush

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Blekinge Institute of Technology: lead

Study Sites (1)

Blekinge Tekniska Högskola

Karlskrona, Blekinge County, 371 79, Sweden

Location

MeSH Terms

Conditions

Periodontal Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT-study

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: The trial protocol and the datasets used and analyzed during the current study are available upon reasonable request.

Locations

SE (1)