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Recruiting NCT06486012

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

No phase Interventional Diabetes Mellitus, Type 2 Pre-diabetes Periodontal Diseases Periodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lumoral Treatment, Standard oral hygiene.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2, Pre-diabetes, Periodontal Diseases, Periodontitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Regular Use of Antibacterial Photodynamic Therapy in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients - Special Attention to Diabetic Balance and Metabolism

Overview

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.

Interventions

  • Device Lumoral Treatment
    Photodynamic antibacterial dual-light device home-use with a marker substance
  • Other Standard oral hygiene
    Standard oral hygiene performed at home

Primary outcome measures

  • Bleeding on probing (BOP) [Time frame: 12 months]
Secondary outcome measures (12)
  • Visual Plaque Index (VPI) [Time frame: 6 months]
  • Visual Plaque Index (VPI) [Time frame: 12 months]
  • Periodontal Pocket Depth (PPD) [Time frame: 6 months]
  • Periodontal Pocket Depth (PPD) [Time frame: 12 months]
  • Clinical Attachment Level (CAL) [Time frame: 6 months]
  • Clinical Attachment Level (CAL) [Time frame: 12 months]
  • Active matrix metalloproteinase 8 (aMMP-8) [Time frame: 6 months]
  • Active matrix metalloproteinase 8 (aMMP-8) [Time frame: 12 months]
  • Periodontopathic bacteria [Time frame: 6 months]
  • Periodontopathic bacteria [Time frame: 12 months]
  • Metabolomics [Time frame: 12 months]
  • hsCRP [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Finland · 1 center
  • Wellbeing Services of County Pirkanmaa — Tampere

Publications

  • 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. PMID 34234496
  • 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. PMID 31882408
  • Gasner NS, Schure RS. Periodontal Disease. 2025 May 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554590/ PMID 32119477
  • 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. PMID 31370168
  • 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. PMID 28539867
  • 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. PMID 30897827
  • 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. PMID 36354651
  • 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. PMID 37968796

Identifiers

NCT: NCT06486012 · R24021L

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗