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.

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 60 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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: a Randomized Controlled Trial.

Conditions

Periodontal Diseases, Oral Halitosis

Being tested

Oral-B Powered toothbrush, Dual-Light aPDT Treatment - Lumoral

Keywords

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

Medical subject headings

Periodontal Diseases, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Oral-B Powered toothbrushDevice

  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 - LumoralDevice

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

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

2. 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.

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

3. 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.

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

4. 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.

   Measured: Baseline

5. 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.

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

6. 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.

   Measured: Assessments will be conducted from baseline to 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted10 Sep 2025
2. Study start10 Apr 2026
3. Primary completionDec 2027 (estimated)
4. Study completionDec 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.