Regular Use of aPDT in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients

NCT ID: NCT06486012

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-23
• Study Completion Date: 2028-12-31

Brief Summary

This is an investigator-initiated clinical study to establish easy referral and access for diabetic patients from primary health care to oral health care facilities for preventive oral care, periodontal assessment, and treatment, and to investigate the impact of regular home use of aPDT medical device on plaque control and gingival health, when used as an adjunct treatment to standard oral hygiene, and the effect on diabetes control in patients with the risk of periodontal disease, compared to a standard home care oral hygiene regimen.

Detailed Description

In earlier studies, a bi-directional link between diabetes and periodontitis has been established: high glucose levels increase the risk of periodontitis while glycemic control is likely to worsen with untreated periodontitis. The treatment of diabetic patients should include easy access from diabetes clinics to oral health care facilities to reduce the potential risks of periodontal disease, or deterioration of existing symptoms of periodontal disease. As part of a holistic approach to healthcare and its resources, more attention needs to be paid to the early detection, and prevention of oral diseases in diabetic patients. Novel testing and treatment methods can play a key role, and a good collaboration between diabetes and oral health care facilities is essential.

The aMMP-8 test can be used to assess the risk of periodontal disease. If the test is positive, latent MMP-8 is activated, so the inflammatory cascade is activated and provides real-time information. The test can also be used to monitor the success of the treatment outcome and can be used to determine the interval between maintenance treatments. In addition, patients' oral self-care should be improved, as most of the work in preventing oral diseases is done at home. The home use of photodynamic dual light therapy (aPDT) can provide additional benefits and also engage patients not only in self-care but also in the whole treatment process. Preliminary studies show that aPDT improves the treatment and maintenance outcomes, and potentially reduces the risk of periodontal disease in addition to self-care.

The combination of easy access to treatment could have wide benefits individually, and also at the community level, including the possibility of building a cost-effective preventive care pathway for patients with prediabetes, type 2 diabetes, and periodontitis, and identifying the risks of both diseases and treating already detected diseases early and in a timely manner.

Conditions

Diabetes Mellitus, Type 2; Pre-diabetes; Periodontal Diseases; Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study group

Standard oral hygiene and home-use of Lumoral Treatment aPDT device.

Group Type: EXPERIMENTAL

Lumoral Treatment

Intervention Type: DEVICE

Photodynamic antibacterial dual-light device home-use with a marker substance

Standard oral hygiene

Intervention Type: OTHER

Standard oral hygiene performed at home

Control group

Standard oral hygiene

Group Type: ACTIVE_COMPARATOR

Standard oral hygiene

Intervention Type: OTHER

Standard oral hygiene performed at home

Interventions

Lumoral Treatment

Photodynamic antibacterial dual-light device home-use with a marker substance

Intervention Type: DEVICE

Standard oral hygiene

Standard oral hygiene performed at home

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diabetic patient treated at community health care;
• At least 18 years old;
• Presence of ≥20 teeth;
• Agreement to participate in the study, and to sign a written consent form;
• Ability to cooperate with the treatment protocol according to coordinator investigator's assessment.

Exclusion Criteria

• Oral thrush;
• Known sensitivity to near-infrared or antibacterial blue light.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

Mehiläinen Health Care Services

UNKNOWN

Sponsor Role: collaborator

Tampere University

OTHER

Sponsor Role: collaborator

Wellbeing Services County of Pirkanmaa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Maria Heikkinen, Professor

Role: PRINCIPAL_INVESTIGATOR

Wellbeing Services of County Pirkanmaa

Locations

Wellbeing Services of County Pirkanmaa

Tampere, Pirkanmaa, Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Miia Ehrnrooth

Role: CONTACT

miia.ehrnrooth@mehilainen.fi

+358406615307

Mikko Kylmänen, Master of Health Care

Role: CONTACT

mikko.kylmanen@gmail.com

Facility Contacts

Miia Ehrnrooth

Role: primary

miia.ehrnrooth@mehilainen.fi

+358406615307

Mikko Kylmänen, Master of Health Care

Role: backup

mikko.kylmanen@gmail.com

References

Ahmad R, Haque M. Oral Health Messiers: Diabetes Mellitus Relevance. Diabetes Metab Syndr Obes. 2021 Jul 1;14:3001-3015. doi: 10.2147/DMSO.S318972. eCollection 2021.

Reference Type: BACKGROUND

PMID: 34234496 (View on PubMed)

Choi SE, Sima C, Pandya A. Impact of Treating Oral Disease on Preventing Vascular Diseases: A Model-Based Cost-effectiveness Analysis of Periodontal Treatment Among Patients With Type 2 Diabetes. Diabetes Care. 2020 Mar;43(3):563-571. doi: 10.2337/dc19-1201. Epub 2019 Dec 27.

Reference Type: BACKGROUND

PMID: 31882408 (View on PubMed)

Gasner NS, Schure RS. Periodontal Disease. 2025 May 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554590/

Reference Type: BACKGROUND

PMID: 32119477 (View on PubMed)

Kononen E, Gursoy M, Gursoy UK. Periodontitis: A Multifaceted Disease of Tooth-Supporting Tissues. J Clin Med. 2019 Jul 31;8(8):1135. doi: 10.3390/jcm8081135.

Reference Type: BACKGROUND

PMID: 31370168 (View on PubMed)

Nazir MA. Prevalence of periodontal disease, its association with systemic diseases and prevention. Int J Health Sci (Qassim). 2017 Apr-Jun;11(2):72-80.

Reference Type: BACKGROUND

PMID: 28539867 (View on PubMed)

Liccardo D, Cannavo A, Spagnuolo G, Ferrara N, Cittadini A, Rengo C, Rengo G. Periodontal Disease: A Risk Factor for Diabetes and Cardiovascular Disease. Int J Mol Sci. 2019 Mar 20;20(6):1414. doi: 10.3390/ijms20061414.

Reference Type: BACKGROUND

PMID: 30897827 (View on PubMed)

Pakarinen 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.

Reference Type: BACKGROUND

PMID: 36354651 (View on PubMed)

Salminen A, Maatta AM, Mantyla P, Leskela J, Pietiainen M, Buhlin K, Suominen AL, Paju S, Sattler W, Sinisalo J, Pussinen PJ. Systemic Metabolic Signatures of Oral Diseases. J Dent Res. 2024 Jan;103(1):13-21. doi: 10.1177/00220345231203562. Epub 2023 Nov 15.

Reference Type: BACKGROUND

PMID: 37968796 (View on PubMed)

Related Links

https://doi.org/10.1007/s00784-021-03871-2

Bashir, N.Z., Singh, HA. \& Virdee, S.S. Indocyanine green-mediated antimicrobial photodynamic therapy as an adjunct to periodontal therapy: a systematic review and meta-analysis. Clin Oral Invest 25, 5699-5710 (2021).

https://doi.org/10.1186/s12874-021-01303-z

Berger, V., Bour, L., Carter, K. et al. A roadmap to using randomization in clinical trials. BMC Med Res Methodol 21, 168 (2021).

https://doi.org/10.3389/fdmed.2021.709831

Borgnakke, W.S., Poudel, P. Front. Dent. Med, Volume 2 - 2021. Diabetes and Oral Health: Summary of Current Scientific Evidence for Why Transdisciplinary Collaboration Is Needed.

https://www.cdc.gov/oral-health/about/gum-periodontal-disease.html

Centers for Disease Control and Prevention (CDC), July 2023. Periodontal Disease.

https://doi.org/10.3389/froh.2022.897115

Sorsa, T, Nwhator, SO, Sakellari, D, Grigoriadis, A, Umeizudike, KA, Brandt, E, Keskin, M, Tervahartiala, T, Pärnänen, P, Gupta, S, Mohindra, R, Bostanci, N, Buduneli, N, Räisänen, IT. Front. Oral Health, 10 June 2022, Sec. Oral Infections and Microbes

https://www.who.int/news-room/fact-sheets/detail/diabetes

World Health Organization (WHO). Diabetes, Oct 2023. Newsroom, Fact sheets, Detail, Diabetes.

http://dx.doi.org/10.5888/pcd18.200594

Zhang Y., Leveille S.G., Shi L., Camhi S.M. Disparities in Preventive Oral Health Care and Periodontal Health Among Adults With Diabetes. Prev Chronic Dis 2021;18:200594

Other Identifiers

R24021L

Identifier Type: -

Identifier Source: org_study_id