Periodontal Diseasese-DENT IINCT07166224
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 study testing Oral-B Powered toothbrush and Dual-Light aPDT Treatment - Lumoral in people with Periodontal Diseases and Oral Halitosis, run by Blekinge Institute of Technology at 2 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Periodontal Diseases, Oral Halitosis
- What is being tested?
- Oral-B Powered toothbrush and Dual-Light aPDT Treatment - Lumoral
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSweden
- Study dates
- 10 Apr 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adults aged ≥60 years
- ≥15 teeth
- Diagnosed periodontitis stage I-III
- MMSE score between 22-28
- Able to provide informed consent
Who cannot join
- Antibiotic use (within 3 months)
- Lumoral use within 3 months
- Bisphosphonate medication
- Immunosuppressive drugs or radiation therapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Blekinge Tekniska Högskola
Karlskrona, Blekinge County, 371 79
Johan Sanmartin Berglund Professor, +46 (0) 455-385471, johan.sanmartin.berglund@bth.se
Evelina Klingborg PhD student, +46 732407575, evelina.klingborg@bth.se
- Recruiting
Blekinge Tekniska Högskola
Karlskrona, Blekinge County, 37179
Evelina Klingborg PhD student and dental hygienist, +46 (0) 732407575, evelina.klingborg@bth.se
Johan Flyborg, +46 (0)455-385447, johan.flyborg@bth.se
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.
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.
Read more
- 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?
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Partisipants with Lumoral Dual-Light aPDT + Manual Toothbrush | Experimental | Not described Receives: Device: Dual-Light aPDT Treatment - Lumoral |
| Partisipants with Oral-B iO Powered Toothbrush | Experimental | Not described Receives: Device: Oral-B Powered toothbrush |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
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
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.
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.
- First posted10 Sep 2025
- Study start10 Apr 2026
- Primary completionDec 2027 (estimated)
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT-study
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blekinge Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166224
- Sponsor's protocol ID
- BTH-6.1.1-0172-2025
- Acronym
- e-DENT II
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The trial protocol and the datasets used and analyzed during the current study are available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07166224
- Acronym / sponsor ID
- e-DENT II / BTH-6.1.1-0172-2025
- Conditions
- Periodontal Diseases, Oral Halitosis
- Keywords
- Mild Cognitive Impairment, Oral health, Quality of life, Powered toothbrush
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Blekinge Institute of TechnologyUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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?
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- RCT-study
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥60 years
- ≥15 teeth
- Diagnosed periodontitis stage I-III
- MMSE score between 22-28
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Antibiotic use (within 3 months)
- Lumoral use within 3 months
- Bisphosphonate medication
- Immunosuppressive drugs or radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral-B Powered toothbrushIntervention 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. | Device | Partisipants with Oral-B iO Powered Toothbrush |
| Dual-Light aPDT Treatment - LumoralIntervention 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. | Device | Partisipants with Lumoral Dual-Light aPDT + Manual Toothbrush |
Primary outcome
Change in the amount of dental plaque
Time frame: Assessments will be conducted at baseline, at 3 months, and at 6 months.
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.
Change in the amount of gingival bleeding on probing
Time frame: Assessments will be conducted at baseline, at 3 months, and at 6 months.
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.
Change in the number of periodontal pockets ≥4 mm in depth
Time frame: Assessments will be conducted at baseline, at 3 months, and at 6 months.
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.
MMSE-test
Time frame: Baseline
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.
Change in the amount of VSCs in the exhaled air
Time frame: Assessments will be conducted at baseline, at 3 months, and at 6 months.
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.
Change in values for the oral health related quality of life instrument OHIP-14
Time frame: Assessments will be conducted from baseline to 6 months.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. The trial protocol and the datasets used and analyzed during the current study are available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral-B Powered toothbrush and Dual-Light aPDT Treatment - Lumoral in people with Periodontal Diseases and Oral Halitosis, run by Blekinge Institute of Technology at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the amount of dental plaque (time frame: Assessments will be conducted at baseline, at 3 months, and at 6 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.