Clinical trial NCT06486012: Regular Use of aPDT in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Pre-diabetes
Periodontal Diseases
Periodontitis
Keywords: periodontitis
diabetes
T2D
aPDT
aMMP-8
Lead sponsor: Wellbeing Services County of Pirkanmaa
Sponsor class: OTHER
Collaborators: name: Tampere University
name: University of Helsinki
name: Mehiläinen Health Care Services
First posted: 2024-07-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical study on a medical device.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Bleeding on probing (BOP)
timeFrame: 12 months
Secondary outcomes:
measure: Visual Plaque Index (VPI)
timeFrame: 6 months
measure: Visual Plaque Index (VPI)
timeFrame: 12 months
measure: Periodontal Pocket Depth (PPD)
timeFrame: 6 months
measure: Periodontal Pocket Depth (PPD)
timeFrame: 12 months
measure: Clinical Attachment Level (CAL)
timeFrame: 6 months
measure: Clinical Attachment Level (CAL)
timeFrame: 12 months
measure: Active matrix metalloproteinase 8 (aMMP-8)
timeFrame: 6 months
measure: Active matrix metalloproteinase 8 (aMMP-8)
timeFrame: 12 months
measure: Periodontopathic bacteria
timeFrame: 6 months
measure: Periodontopathic bacteria
timeFrame: 12 months
measure: Metabolomics
timeFrame: 12 months
measure: hsCRP
timeFrame: 12 months
measure: LPS
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Wellbeing Services of County Pirkanmaa
state: Pirkanmaa
Study officials:
affiliation: Wellbeing Services of County Pirkanmaa
name: Anna Maria Heikkinen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.