Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus

Study Overview
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Brief Summary
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With this design, this study hypothesizes that; (i) ICG-PDT would produce superior clinical, microbiological, and immune-inflammatory outcomes as compared to RSD and (ii) ICG-PDT would produce equal efficacy among different forms of diabetes as produced in non-diabetic subjects and that diabetes mellitus would not produce negative impact on the therapeutic outcomes of ICG-PDT. Therefore, the aim of this randomized controlled clinical trial was to evaluate the efficacy of ICG-mediated aPDT in the treatment of stage III grade C periodontitis among patients with prediabetes, T2DM and non-diabetic subjects.

Official Title
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Indocyanine-mediated Antimicrobial Photodynamic Therapy Promotes Superior Clinical Effects in Stage III and Grade C Chronic Periodontitis Among Different Forms of Diabetes Mellitus: A Randomized Controlled Clinical Trial

Conditions
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Type 2 Diabetes Mellitus, Prediabetic State, Chronic Periodontitis

Intervention / Treatment
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* Drug: Indocyanine green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged ≥30 years clinically diagnosed with mild to moderate periodontitis self-reported type-2 DM for ≥2 years confirmed by a physician with HbA1c levels ≥6.5% patients who complied with the treatment protocol. Exclusion Criteria: (i) pregnancy and lactation (ii) who had taken antibiotics in the previous 3 months (iii) who had undergone periodontal therapy or any decontamination treatment in their oral cavity in the previous 6 months (iv) former/current smokers (v) failure to provide a signed informed consent.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Controlled Type 2 diabetes mellitus<br> | Drug: Indocyanine green<br>* Single application of PDT will be performed. A diode laser (HELBO®TheraLite - Bredent Medical, Germany) with 670 nm wavelength, power of 150 mW, fluency of 22 J/cm2 and density of 1.1 W/cm2 will be used in this study. Indocyanine-green photosensitizer (Sigm Aldrich, USA) with 0.005% concentration will be used as a photosensitizer which will be applied inside the periodontal pockets in a depth of 3 mm with the help of a blunt needle for 10 s. Laser irradiation will be performed for 60 s using a flexible tip. Laser irradiation will be performed at 2 points each on buccal and lingual with the tip stabilized perpendicular to the gingival tissues.<br>* Other names: Photodynamic therapy;|
| Experimental: Uncontrolled Type 2 diabetes melltius<br> | Drug: Indocyanine green<br>* Single application of PDT will be performed. A diode laser (HELBO®TheraLite - Bredent Medical, Germany) with 670 nm wavelength, power of 150 mW, fluency of 22 J/cm2 and density of 1.1 W/cm2 will be used in this study. Indocyanine-green photosensitizer (Sigm Aldrich, USA) with 0.005% concentration will be used as a photosensitizer which will be applied inside the periodontal pockets in a depth of 3 mm with the help of a blunt needle for 10 s. Laser irradiation will be performed for 60 s using a flexible tip. Laser irradiation will be performed at 2 points each on buccal and lingual with the tip stabilized perpendicular to the gingival tissues.<br>* Other names: Photodynamic therapy;|
| Active Comparator: Non-diabetic patients<br> | Drug: Indocyanine green<br>* Single application of PDT will be performed. A diode laser (HELBO®TheraLite - Bredent Medical, Germany) with 670 nm wavelength, power of 150 mW, fluency of 22 J/cm2 and density of 1.1 W/cm2 will be used in this study. Indocyanine-green photosensitizer (Sigm Aldrich, USA) with 0.005% concentration will be used as a photosensitizer which will be applied inside the periodontal pockets in a depth of 3 mm with the help of a blunt needle for 10 s. Laser irradiation will be performed for 60 s using a flexible tip. Laser irradiation will be performed at 2 points each on buccal and lingual with the tip stabilized perpendicular to the gingival tissues.<br>* Other names: Photodynamic therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Probing depth will be measured to the nearest millimeter from the base of the periodontal pocket to the crest of the marginal gingiva. | 6 months | 
| Clinical attachment level | Clinical attachment level will be measured by adding recession with probing depth | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque scores | Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent' | 6 months | 
| Bleeding on probing | Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent' | 6 months | 
| Porphyromonas gingivalis | Presence or absence of bacteria from the plaque biofilms in the patient | 6 months | 
| Interleukin-6 | Proinflammatory cytokine levels that will be quantified in the laboratory. | 6 months |