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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlled Type 2 diabetes mellitus | Experimental |
| |
| Uncontrolled Type 2 diabetes melltius | Experimental |
| |
| Non-diabetic patients | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green | Drug | 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. |
| 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 |
| 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' |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Applied Medical Sciences, King Saud University | Riyadh | 11454 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34087466 | Derived | Al-Momani MM. Indocyanine-mediated antimicrobial photodynamic therapy promotes superior clinical effects in stage III and grade C chronic periodontitis among controlled and uncontrolled diabetes mellitus: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102379. doi: 10.1016/j.pdpdt.2021.102379. Epub 2021 Jun 1. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| 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 |
| D004700 | Endocrine System Diseases |
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |