PeriodontitisNCT05962801
Use of Dual-light Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers
A study testing Lumoral device, Lumorinse in people with Periodontitis and Dual- Light Photodynamic Therapy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The goal of this controlled clinical trial is to investigate the impact of regular home use of Lumoral device as an adjunct treatment compared to non-surgical periodontitis treatment (NSPT) alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.The main question… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Dual- Light Photodynamic Therapy, Smoking, Cigarette
- What is being tested?
- Lumoral device, Lumorinse
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 23 Jan 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Periodontal disease Stage III and Grade C with at least 6 sites with probing depth (PD) and clinical attachment loss (CAL) ≥5 mm and bleeding on probing (BoP) ≥15 teeth
- aged ≥35
- Smokers smoking ≥10 cigarettes per day
Who cannot join
- Patients allergic to indocyanine
- Patients with active carious lesions
- Need for prophylactic antimicrobial coverage
- Scaling and root planing in the previous 6 months
- Non-smoking status or smoking less than 10 cigarettes per day
- Antimicrobial therapy in the previous 6 months
Show all 9Show fewer
- Immunomodifying conditions/ diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis)
- Long-term use of medication that could interfere with periodontal response (e.g. biphosphonates)
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Dental School of Aristotle University of Thessaloniki
Thessaloniki, 54124
Chrysoula Vakaki, Postgraduate, 0030 6979766034, vakakichri@gmail.com
Dimitra Sakellari, Professor, 0030 6945777768, dimisak@dent.auth.gr
About this study
Official title: Regular Home Use of Dual-light Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment in Smokers
The goal of this controlled clinical trial is to investigate the impact of regular home use of Lumoral device as an adjunct treatment compared to non-surgical periodontitis treatment (NSPT) alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.The main question aims to answer is:
- Does regular use of dual-light photodynamic therapy benefit NSPT in Stage III and Grade C smoking periodontitis patients?
30 participants will be asked to use Lumoral device every night before performing oral hygiene for 10 minutes, while the other 30 patients will be asked to perform only oral hygiene. Both of these groups will receive NSPT and will be followed for 6 months from baseline.
Read the detailed description
The objective of this study is to investigate the impact of regular home use of Lumoral device® as an adjunct treatment compared to non-surgical periodontal treatment alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.
Lumoral® is based on a dual-wavelength LED light that activates Lumorinse® (exocellular) and bacteria porphyrins (endocellular), resulting in the formation of reactive oxygen species (ROS). ROS and heat induce a series of photochemical and biological events that cause irreversible inactivation leading to the death of undesired bacteria. This device is designed for home use.
Therefore it is hypothesized that its adjunct use in the treatment of periodontitis could lead to better outcomes compared to traditional periodontal treatment. In order to investigate this impact, clinical and microbiological measurements will be compared between patients who will be treated with conventional non-surgical periodontal treatment and patients who will receive the Lumoral device® as an adjunct to the periodontal treatment. The patients who receive the device will use it every day for four months. Both groups will be followed for 6 months.
- Conditions
- Periodontitis, Dual- Light Photodynamic Therapy, Smoking, Cigarette, Non-surgical Periodontal Therapy
- Being tested
- Lumoral device, Lumorinse
- Keywords
- periodontitis, periodontal diseases, photodynamic therapy, photothermal therapy, smoking, non-surgical periodontitis therapy
- Medical subject headings
- Periodontitis, Cigarette Smoking, Periodontal Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumoral device, LumorinseDevice
Regular use of dual-light photodynamic therapy at home
| Study group | Role | What they receive |
|---|---|---|
| Lumoral users | Active comparator | Use of Lumoral device and Lumorinse mouthwash once per day for 6 months and performance of oral hygiene twice per day for 6 months. Receives: Device: Lumoral device, Lumorinse |
| Lumoral non-users | No intervention | No use of Lumoral device and Lumorinse mouthwash. Performance of oral hygiene twice per day for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bleeding on probing (BOP)
Changes in the presence of bleeding when probing at 6 sites per tooth. It is evaluated dichotomously.
Measured: baseline, 2 weeks, 2 months, 6 months
Secondary outcomes (7)
Changes of pocket depths
Changes in measurement in millimeters of the depth from the gingival margin to the epithelial attachment in unhealthy gingival tissue at 6 sites per tooth
Measured: baseline, 2 months, 6 months
Changes in clinical attachment level
Changes in measurement of the position of the gingival margin in relation to the cemento-enamel junction (CEJ) at 6 sites per tooth
Measured: baseline, 2 months, 6 months
Difference in the number of "closed" pockets
Differences in the number of pockets with depth≤ 4mm and no BOP between the test and the control group
Measured: baseline, 2 months, 6 months
a-MMP8 saliva concentration
Periosafe chair-side tests and the ORALyzer (an advanced lateral flow (aLF) reader) are utilized in order to quantify active MMP-8 in subjects' saliva
Measured: baseline, 2 weeks, 2 months, 6 months
Changes in Turetsky Modified Quigley-Hein Plaque Index (TMQHPI)
Changes in TMQHPI in buccal surfaces of the upper and lower anterior teeth.
A score of 0 to five is assigned to each buccak surface of upper and lower anterior teeth, as follows:
0 = No plaque.
- = Separate flecks of plaque at the cervical margin of the tooth.
- = A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth.
- = A band of plaque wider than one mm but covering less than one-third of the crown of the tooth.
- = Plaque covering at least one-third but less than two thirds of the crown of the tooth.
- = Plaque covering two-thirds or more of the crown of the tooth. An index for the anterior teeth is determined by dividing the total score by the number surfaces examined. The score is rounded up to the second decimal number and it ranges from 0 to 5.
Measured: baseline, 2 weeks, 2 months, 6 months
Oral health-related quality of life questionnaire (OHQL)
OHQL includes the following questions:
- Did you use Lumoral® as instructed to you?
- Did you find Lumoral® easy to use?
- Did you feel any discomfort when using Lumoral®?
- Did you discontinue the use of Lumoral® due to this discomfort?
- Did Lumoral® help you perform oral hygiene?
- Has bad breath been decreased?
- Has bleeding of the gums been decreased?
- Would you recommend Lumoral®?
- Would you buy Lumoral® if its cost was about 200 €?
All questions will be answered with a 'Yes' or 'No'
Measured: 2 months, 6 months
Changes in the presence of periopathogens in the deepest pocket
Subgingival plaque sample is collected from the deepest pocket of each patient and the presence of periopathogens is detected
Measured: baseline, 2 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start23 Jan 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Dimitra Sakellari, Aristotle University Of Thessaloniki
- Investigators
- Dimitra Sakellari, Professor, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962801
- Sponsor's protocol ID
- 176/30-11-2022
- Status last verified
- Sep 2023
- First submitted
- 19 Jul 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients' data will be recorded in the electronic patients' database of the Dental School of Aristotle University of Thessaloniki and only the researchers of this study will have access to them.
Publications
AlSarhan MA, Altammami MA, Alaqeely RS, AlEbdi A, Jasser RA, Otaibi DA, Oraini SA, Habib SR, Alqahtani L, Alduhaymi IS, Alrabiah DK, Alaradi M, Alyamani EJ. Short-term improvement of clinical parameters and microbial diversity in periodontitis patients following Indocyanine green-based antimicrobial photodynamic therapy: A randomized single-blind split-mouth cohort. Photodiagnosis Photodyn Ther. 2021 Sep;35:102349. doi: 10.1016/j.pdpdt.2021.102349. Epub 2021 May 24.
PubMed 34033939Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.
PubMed 35723308Trujiilo K, Raisanen IT, Sorsa T, Patila T. Repeated Daily Use of Dual-Light Antibacterial Photodynamic Therapy in Periodontal Disease-A Case Report. Dent J (Basel). 2022 Sep 1;10(9):163. doi: 10.3390/dj10090163.
PubMed 36135158Alassiri S, Parnanen P, Rathnayake N, Johannsen G, Heikkinen AM, Lazzara R, van der Schoor P, van der Schoor JG, Tervahartiala T, Gieselmann D, Sorsa T. The Ability of Quantitative, Specific, and Sensitive Point-of-Care/Chair-Side Oral Fluid Immunotests for aMMP-8 to Detect Periodontal and Peri-Implant Diseases. Dis Markers. 2018 Aug 5;2018:1306396. doi: 10.1155/2018/1306396. eCollection 2018.
PubMed 30154936Jansson H, Wahlin A, Johansson V, Akerman S, Lundegren N, Isberg PE, Norderyd O. Impact of periodontal disease experience on oral health-related quality of life. J Periodontol. 2014 Mar;85(3):438-45. doi: 10.1902/jop.2013.130188. Epub 2013 Jul 29.
PubMed 23895254Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
PubMed 5264376Chambrone L, Wang HL, Romanos GE. Antimicrobial photodynamic therapy for the treatment of periodontitis and peri-implantitis: An American Academy of Periodontology best evidence review. J Periodontol. 2018 Jul;89(7):783-803. doi: 10.1902/jop.2017.170172.
PubMed 30133749Pakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206.
PubMed 36354651Vakaki C, Fragkioudakis I, Patila T, Sakellari D. Regular home use of dual-light photodynamic therapy as an adjunct to non-surgical periodontal treatment in smokers: a single-center randomized controlled clinical trial. Clin Oral Investig. 2025 Nov 6;29(12):553. doi: 10.1007/s00784-025-06600-1.
PubMed 41196397
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular Home Use of Dual-light Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment in Smokers
- ClinicalTrials.gov ID
- NCT05962801
- Acronym / sponsor ID
- 176/30-11-2022
- Conditions
- Periodontitis, Dual- Light Photodynamic Therapy, Smoking, Cigarette, Non-surgical Periodontal Therapy
- Keywords
- periodontitis, periodontal diseases, photodynamic therapy, photothermal therapy, smoking, non-surgical periodontitis therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 27 Jul 2023 (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.
The goal of this controlled clinical trial is to investigate the impact of regular home use of Lumoral device as an adjunct treatment compared to non-surgical periodontitis treatment (NSPT) alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.The main question aims to answer is:
- Does regular use of dual-light photodynamic therapy benefit NSPT in Stage III and Grade C smoking periodontitis patients?
30 participants will be asked to use Lumoral device every night before performing oral hygiene for 10 minutes, while the other 30 patients will be asked to perform only oral hygiene. Both of these groups will receive NSPT and will be followed for 6 months from baseline.
Detailed description
The objective of this study is to investigate the impact of regular home use of Lumoral device® as an adjunct treatment compared to non-surgical periodontal treatment alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.
Lumoral® is based on a dual-wavelength LED light that activates Lumorinse® (exocellular) and bacteria porphyrins (endocellular), resulting in the formation of reactive oxygen species (ROS). ROS and heat induce a series of photochemical and biological events that cause irreversible inactivation leading to the death of undesired bacteria. This device is designed for home use.
Therefore it is hypothesized that its adjunct use in the treatment of periodontitis could lead to better outcomes compared to traditional periodontal treatment. In order to investigate this impact, clinical and microbiological measurements will be compared between patients who will be treated with conventional non-surgical periodontal treatment and patients who will receive the Lumoral device® as an adjunct to the periodontal treatment. The patients who receive the device will use it every day for four months. Both groups will be followed for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Lumoral users | Active comparator | Device: Lumoral device, LumorinseUse of Lumoral device and Lumorinse mouthwash once per day for 6 months and performance of oral hygiene twice per day for 6 months. |
| Lumoral non-users | No intervention | –No use of Lumoral device and Lumorinse mouthwash. Performance of oral hygiene twice per day for 6 months. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Periodontal disease Stage III and Grade C with at least 6 sites with probing depth (PD) and clinical attachment loss (CAL) ≥5 mm and bleeding on probing (BoP) ≥15 teeth
- aged ≥35
- Smokers smoking ≥10 cigarettes per day
Key exclusion criteria (9 listed)
- Patients allergic to indocyanine
- Patients with active carious lesions
- Need for prophylactic antimicrobial coverage
- Scaling and root planing in the previous 6 months
- Non-smoking status or smoking less than 10 cigarettes per day
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 |
|---|---|---|
| Lumoral device, LumorinseRegular use of dual-light photodynamic therapy at home | Device | Lumoral users |
Primary outcome
Changes in bleeding on probing (BOP)
Time frame: baseline, 2 weeks, 2 months, 6 months
Changes in the presence of bleeding when probing at 6 sites per tooth. It is evaluated dichotomously.
7 secondary outcomes
Changes of pocket depths
Time frame: baseline, 2 months, 6 months
Changes in clinical attachment level
Time frame: baseline, 2 months, 6 months
Difference in the number of "closed" pockets
Time frame: baseline, 2 months, 6 months
a-MMP8 saliva concentration
Time frame: baseline, 2 weeks, 2 months, 6 months
Changes in Turetsky Modified Quigley-Hein Plaque Index (TMQHPI)
Time frame: baseline, 2 weeks, 2 months, 6 months
Oral health-related quality of life questionnaire (OHQL)
Time frame: 2 months, 6 months
Changes in the presence of periopathogens in the deepest pocket
Time frame: baseline, 2 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Background: PubMed 34033939AlSarhan MA, Altammami MA, Alaqeely RS, AlEbdi A, Jasser RA, Otaibi DA, Oraini SA, Habib SR, Alqahtani L, Alduhaymi IS, Alrabiah DK, Alaradi M, Alyamani EJ. Short-term improvement of clinical parameters and microbial diversity in periodontitis patients following Indocyanine green-based antimicrobial photodynamic therapy: A randomized single-blind split-mouth cohort. Photodiagnosis Photodyn Ther. 2021 Sep;35:102349. doi: 10.1016/j.pdpdt.2021.102349. Epub 2021 May 24.
- Background: PubMed 35723308Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.
- Background: PubMed 36135158Trujiilo K, Raisanen IT, Sorsa T, Patila T. Repeated Daily Use of Dual-Light Antibacterial Photodynamic Therapy in Periodontal Disease-A Case Report. Dent J (Basel). 2022 Sep 1;10(9):163. doi: 10.3390/dj10090163.
- Background: PubMed 30154936Alassiri S, Parnanen P, Rathnayake N, Johannsen G, Heikkinen AM, Lazzara R, van der Schoor P, van der Schoor JG, Tervahartiala T, Gieselmann D, Sorsa T. The Ability of Quantitative, Specific, and Sensitive Point-of-Care/Chair-Side Oral Fluid Immunotests for aMMP-8 to Detect Periodontal and Peri-Implant Diseases. Dis Markers. 2018 Aug 5;2018:1306396. doi: 10.1155/2018/1306396. eCollection 2018.
- Background: PubMed 23895254Jansson H, Wahlin A, Johansson V, Akerman S, Lundegren N, Isberg PE, Norderyd O. Impact of periodontal disease experience on oral health-related quality of life. J Periodontol. 2014 Mar;85(3):438-45. doi: 10.1902/jop.2013.130188. Epub 2013 Jul 29.
- Background: PubMed 5264376Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
- Background: PubMed 30133749Chambrone L, Wang HL, Romanos GE. Antimicrobial photodynamic therapy for the treatment of periodontitis and peri-implantitis: An American Academy of Periodontology best evidence review. J Periodontol. 2018 Jul;89(7):783-803. doi: 10.1902/jop.2017.170172.
- Background: PubMed 36354651Pakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206.
- Derived from this study: PubMed 41196397Vakaki C, Fragkioudakis I, Patila T, Sakellari D. Regular home use of dual-light photodynamic therapy as an adjunct to non-surgical periodontal treatment in smokers: a single-center randomized controlled clinical trial. Clin Oral Investig. 2025 Nov 6;29(12):553. doi: 10.1007/s00784-025-06600-1.
- Individual participant dataSharing planned: No. Patients' data will be recorded in the electronic patients' database of the Dental School of Aristotle University of Thessaloniki and only the researchers of this study will have access to them.
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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. This study is not recruiting at the moment.
Dimitra Sakellari, Professor study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumoral device, Lumorinse in people with Periodontitis and Dual- Light Photodynamic Therapy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chrysoula Vakaki, Postgraduate (0030 6979766034, vakakichri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bleeding on probing (BOP) (time frame: baseline, 2 weeks, 2 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05962801, which also lists 9 linked publications.
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 4 Oct 2023.