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

NCT06486012 | Recruiting

• 1 other identifier: R24021L
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

periodontitis; diabetes; T2D; aPDT; aMMP-8

Outcome Measures

Primary Outcomes (1)

• Bleeding on probing (BOP)

  Change in bleeding on probing (BOP) A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent" BOP is reported as the percentage (%) of sites with positive findings Calculation formula: number of bleeding sites/ 6 times number of teeth

  12 months

Secondary Outcomes (13)

• Visual Plaque Index (VPI)

  6 months

• Visual Plaque Index (VPI)

  12 months

• Periodontal Pocket Depth (PPD)

  6 months

• Periodontal Pocket Depth (PPD)

  12 months

• Clinical Attachment Level (CAL)

  6 months

Study Arms (2)

Study group

EXPERIMENTAL

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

Device: Lumoral Treatment; Other: Standard oral hygiene

Control group

ACTIVE COMPARATOR

Standard oral hygiene

Other: Standard oral hygiene

Interventions

Lumoral Treatment DEVICE

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

Study group

Standard oral hygiene OTHER

Standard oral hygiene performed at home

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wellbeing Services County of Pirkanmaa: lead
• Tampere University: collaborator
• University of Helsinki: collaborator
• Mehiläinen Health Care Services: collaborator

Study Sites (1)

Wellbeing Services of County Pirkanmaa

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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/

  PMID: 32119477 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• 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).
• Berger, V., Bour, L., Carter, K. et al. A roadmap to using randomization in clinical trials. BMC Med Res Methodol 21, 168 (2021).
• 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.
• Centers for Disease Control and Prevention (CDC), July 2023. Periodontal Disease.
• 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
• World Health Organization (WHO). Diabetes, Oct 2023. Newsroom, Fact sheets, Detail, Diabetes.
• 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance; Periodontal Diseases; Periodontitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Anna Maria Heikkinen, Professor

  Wellbeing Services of County Pirkanmaa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miia Ehrnrooth

CONTACT

+358406615307; miia.ehrnrooth@mehilainen.fi

Mikko Kylmänen, Master of Health Care

CONTACT

mikko.kylmanen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data will be collected using individual study codes for participants. Study codes do not reveal which group the participant has belonged to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical study on a medical device.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: January 23, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)