search
Back to results

Antimicrobial Photodynamic Therapy in Patients With Periodontal Disease and Type 2 Diabetes Mellitus

Primary Purpose

Periodontal Diseases, Diabetes Mellitus, Type 2, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional Periodontal Treatment (Complete Oral Disinfection)
Adjunctive Photodynamic Therapy
Sponsored by
University of Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Type 2 Diabetes Mellitus, Periodontal Disease, Antimicrobial Photodynamic Therapy, Indocyanine Green

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 40 and 75 years Diabetes Mellitus type 2 with an HbA1c value > 7.0%, At least ten teeth in the Maxilla and Mandible At least four teeth with a probing pocket depth ≥ 5 mm and bleeding on probing. Exclusion Criteria: Antibiotic treatment in the last four months Periodontal treatment in the last six months Any change in Antihyperglycaemic treatment three months prior to participation Pregnant women Lactating women Smokers Former smokers who had stopped smoking less than five years before participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Control Arm

    Experimental Arm

    Arm Description

    Conventional Periodontal Treatment: Complete Oral Disinfection.

    Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in periodontal pockets with PPD ≥ 5 mm.

    Outcomes

    Primary Outcome Measures

    Probing pocket depth (PPD)
    Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
    Probing pocket depth (PPD)
    Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
    Bleeding on probing (BOP)
    Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
    Bleeding on probing (BOP)
    Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
    Clinical attachment level (CAL)
    This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
    Clinical attachment level (CAL)
    This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
    The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
    Plaque samples were collected with sterile paper tips after supragingival soft and hard debris had been removed according to the manufacturer's instructions. Analysis by Polymerase chain reaction (PCR) followed by hybridization against species-specific DNA probes. According to the manufacturer, the cut-off of the test is set at 10³ to 10⁴ genome equivalents
    The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
    Plaque samples were collected with sterile paper tips after supragingival soft and hard debris had been removed according to the manufacturer's instructions. Analysis by Polymerase chain reaction (PCR) followed by hybridization against species-specific DNA probes. According to the manufacturer, the cut-off of the test is set at 10³ to 10⁴ genome equivalents
    HbA1c test
    Blood sample. Unit %
    HbA1c test
    Blood sample. Unit %

    Secondary Outcome Measures

    Plaque index (PI)
    Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
    Plaque index (PI)
    Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
    Sulcus bleeding index (SBI)
    es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)
    Sulcus bleeding index (SBI)
    es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)

    Full Information

    First Posted
    March 17, 2023
    Last Updated
    May 17, 2023
    Sponsor
    University of Ljubljana
    Collaborators
    University Medical Centre Ljubljana
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05816941
    Brief Title
    Antimicrobial Photodynamic Therapy in Patients With Periodontal Disease and Type 2 Diabetes Mellitus
    Official Title
    The Effect of Antimicrobial Photodynamic Therapy on Periodontal Disease and Glycemic Control in Patients With Type 2 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 3, 2016 (Actual)
    Primary Completion Date
    January 3, 2019 (Actual)
    Study Completion Date
    January 3, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Ljubljana
    Collaborators
    University Medical Centre Ljubljana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objectives: This study aimed to determine the effect of concomitant antimicrobial photodynamic therapy (aPTD) on periodontal disease and glycaemic control in patients with type 2 diabetes mellitus (T2DM). Clinical Relevance: aPTD is a noninvasive adjunctive therapy that can positively influence the periodontal treatment outcome.
    Detailed Description
    Numerous studies confirm that diabetes mellitus increases the risk of gingivitis and periodontitis. However, periodontal disease also impairs glycaemic control in people with diabetes mellitus via inflammatory mediators. Methods: Twenty-four patients with T2DM were enrolled in the study. Periodontal tissue status and periodontal disease were assessed by measuring probing pocket depth (PPD), bleeding on probing (BOP), clinical attachment loss (CAL), plaque index (PI) and sulcus bleeding index (SBI). Glycated haemoglobin A1c (HbA1c) was measured. To determine the presence of the following periodontal pathogenic bacteria Aggregatibacter actinomycetemcomitans, Prevotella intermedia, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola, subgingival plaque samples were taken from two periodontal pockets with the greatest PPD using paper tips. Patients were randomly divided into the test and control group. In the test group, complete oral disinfection was performed in combination with aPTD. In the control group, only complete oral disinfection was performed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Diseases, Diabetes Mellitus, Type 2, Periodontitis, Periodontal Pocket, Periodontal Attachment Loss, Periodontal Inflammation
    Keywords
    Type 2 Diabetes Mellitus, Periodontal Disease, Antimicrobial Photodynamic Therapy, Indocyanine Green

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Test and Control group. All patients received oral hygiene instructions followed by complete oral disinfection (removal of hard and soft deposits, scaling and root planing, mouth rinse with 0.2% chlorhexidine twice in one minute, pocket rinse with 0.2% chlorhexidine three times in ten minutes). Ultrasonic (Piezoled, KaVo) and hand instruments (Gracey curettes, Hu-Friedy, USA) were used for this purpose. Afterwards, the patients were randomly divided into test and control groups. The patients in the test group received aPDT as adjuvant treatment in pockets with PPD ≥ 5 mm.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Arm
    Arm Type
    Other
    Arm Description
    Conventional Periodontal Treatment: Complete Oral Disinfection.
    Arm Title
    Experimental Arm
    Arm Type
    Experimental
    Arm Description
    Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in periodontal pockets with PPD ≥ 5 mm.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional Periodontal Treatment (Complete Oral Disinfection)
    Intervention Description
    Oral hygiene instructions followed by complete oral disinfection (removal of hard and soft deposits, scaling and root planing, mouth rinse with 0.2% chlorhexidine twice in one minute, pocket rinse with 0.2% chlorhexidine three times in ten minutes). Ultrasonic (Piezoled, KaVo) and hand instruments (Gracey curettes, Hu-Friedy, USA) were used for this purpose. For the next 14 days, all patients were asked to rinse their oral cavities twice daily with 0.12% chlorhexidine.
    Intervention Type
    Procedure
    Intervention Name(s)
    Adjunctive Photodynamic Therapy
    Intervention Description
    Photodynamic Therapy as adjunctive treatment in pockets with PPD ≥ 5 mm. For this purpose, a Fotona XD -2 diode laser (Fotona, Ljubljana, Slovenia) with a wavelength of 810 nm, a power of 250 mW and the photosensitizing agent indocyanine green at a concentration of 1 mg/ml was used. First, the area to be irradiated was isolated, and the photosensitizing agent was applied to the periodontal pocket. After 60 seconds, the supragingival excess of the photosensitizing agent was removed by gentle rinsing with a saline solution. This was followed by irradiation for ten seconds on each side. For the next 14 days, all patients were asked to rinse their oral cavities twice daily with 0.12% chlorhexidine.
    Primary Outcome Measure Information:
    Title
    Probing pocket depth (PPD)
    Description
    Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
    Time Frame
    At baseline
    Title
    Probing pocket depth (PPD)
    Description
    Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
    Time Frame
    90 days after treatment
    Title
    Bleeding on probing (BOP)
    Description
    Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
    Time Frame
    At baseline
    Title
    Bleeding on probing (BOP)
    Description
    Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
    Time Frame
    90 days after treatment
    Title
    Clinical attachment level (CAL)
    Description
    This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
    Time Frame
    At baseline
    Title
    Clinical attachment level (CAL)
    Description
    This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
    Time Frame
    90 days after treatment
    Title
    The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
    Description
    Plaque samples were collected with sterile paper tips after supragingival soft and hard debris had been removed according to the manufacturer's instructions. Analysis by Polymerase chain reaction (PCR) followed by hybridization against species-specific DNA probes. According to the manufacturer, the cut-off of the test is set at 10³ to 10⁴ genome equivalents
    Time Frame
    At baseline
    Title
    The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
    Description
    Plaque samples were collected with sterile paper tips after supragingival soft and hard debris had been removed according to the manufacturer's instructions. Analysis by Polymerase chain reaction (PCR) followed by hybridization against species-specific DNA probes. According to the manufacturer, the cut-off of the test is set at 10³ to 10⁴ genome equivalents
    Time Frame
    90 days after treatment
    Title
    HbA1c test
    Description
    Blood sample. Unit %
    Time Frame
    At baseline
    Title
    HbA1c test
    Description
    Blood sample. Unit %
    Time Frame
    90 days after treatment
    Secondary Outcome Measure Information:
    Title
    Plaque index (PI)
    Description
    Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
    Time Frame
    At baseline
    Title
    Plaque index (PI)
    Description
    Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
    Time Frame
    90 days after treatment
    Title
    Sulcus bleeding index (SBI)
    Description
    es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)
    Time Frame
    At baseline
    Title
    Sulcus bleeding index (SBI)
    Description
    es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)
    Time Frame
    90 days after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 40 and 75 years Diabetes Mellitus type 2 with an HbA1c value > 7.0%, At least ten teeth in the Maxilla and Mandible At least four teeth with a probing pocket depth ≥ 5 mm and bleeding on probing. Exclusion Criteria: Antibiotic treatment in the last four months Periodontal treatment in the last six months Any change in Antihyperglycaemic treatment three months prior to participation Pregnant women Lactating women Smokers Former smokers who had stopped smoking less than five years before participation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rok Schara
    Organizational Affiliation
    Assistant Professor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    All Research data will be available or shared on individual request. Example: conducting Meta-Analysis.
    Citations:
    PubMed Identifier
    26921460
    Citation
    Monzavi A, Chinipardaz Z, Mousavi M, Fekrazad R, Moslemi N, Azaripour A, Bagherpasand O, Chiniforush N. Antimicrobial photodynamic therapy using diode laser activated indocyanine green as an adjunct in the treatment of chronic periodontitis: A randomized clinical trial. Photodiagnosis Photodyn Ther. 2016 Jun;14:93-7. doi: 10.1016/j.pdpdt.2016.02.007. Epub 2016 Feb 24.
    Results Reference
    background
    PubMed Identifier
    18713259
    Citation
    Braun A, Dehn C, Krause F, Jepsen S. Short-term clinical effects of adjunctive antimicrobial photodynamic therapy in periodontal treatment: a randomized clinical trial. J Clin Periodontol. 2008 Oct;35(10):877-84. doi: 10.1111/j.1600-051X.2008.01303.x. Epub 2008 Aug 17.
    Results Reference
    background
    PubMed Identifier
    19563331
    Citation
    Lulic M, Leiggener Gorog I, Salvi GE, Ramseier CA, Mattheos N, Lang NP. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):661-6. doi: 10.1111/j.1600-051X.2009.01432.x. Epub 2009 Jun 25.
    Results Reference
    background
    PubMed Identifier
    19554711
    Citation
    Polansky R, Haas M, Heschl A, Wimmer G. Clinical effectiveness of photodynamic therapy in the treatment of periodontitis. J Clin Periodontol. 2009 Jul;36(7):575-80. doi: 10.1111/j.1600-051x.2009.01412.x.
    Results Reference
    background
    PubMed Identifier
    21166588
    Citation
    Ge L, Shu R, Li Y, Li C, Luo L, Song Z, Xie Y, Liu D. Adjunctive effect of photodynamic therapy to scaling and root planing in the treatment of chronic periodontitis. Photomed Laser Surg. 2011 Jan;29(1):33-7. doi: 10.1089/pho.2009.2727. Epub 2010 Dec 18.
    Results Reference
    background
    PubMed Identifier
    27448223
    Citation
    Castro Dos Santos NC, Andere NM, Araujo CF, de Marco AC, Dos Santos LM, Jardini MA, Santamaria MP. Local adjunct effect of antimicrobial photodynamic therapy for the treatment of chronic periodontitis in type 2 diabetics: split-mouth double-blind randomized controlled clinical trial. Lasers Med Sci. 2016 Nov;31(8):1633-1640. doi: 10.1007/s10103-016-2030-8. Epub 2016 Jul 22.
    Results Reference
    background

    Learn more about this trial

    Antimicrobial Photodynamic Therapy in Patients With Periodontal Disease and Type 2 Diabetes Mellitus

    We'll reach out to this number within 24 hrs