Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus

King Saud University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus Prediabetic State Chronic Periodontitis

Interventions

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. aged ≥30 years 2. clinically diagnosed with mild to moderate periodontitis 3. self-reported type-2 DM for ≥2 years confirmed by a physician with HbA1c levels ≥6.5% 4. 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.

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Clinical attachment level

Clinical attachment level will be measured by adding recession with probing depth

Time frame: 6 months

Secondary Outcomes

Plaque scores

Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'

Time frame: 6 months

Bleeding on probing

Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'

Time frame: 6 months

Porphyromonas gingivalis

Presence or absence of bacteria from the plaque biofilms in the patient

Time frame: 6 months

Interleukin-6

Proinflammatory cytokine levels that will be quantified in the laboratory.

Time frame: 6 months

Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes