Chronic Periodontitis, Prediabetic State, Type 2 Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
DRUGIndocyanine green
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.
Sponsors
King Saud University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | 6 months | Probing depth will be measured to the nearest millimeter from the base of the periodontal pocket to the crest of the marginal gingiva. |
| Clinical attachment level | 6 months | Clinical attachment level will be measured by adding recession with probing depth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque scores | 6 months | Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent' |
| Bleeding on probing | 6 months | Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent' |
| Porphyromonas gingivalis | 6 months | Presence or absence of bacteria from the plaque biofilms in the patient |
| Interleukin-6 | 6 months | Proinflammatory cytokine levels that will be quantified in the laboratory. |
Countries
Saudi Arabia
Outcome results
None listed