Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus

King Saud University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Prediabetic State

Type 2 Diabetes Mellitus

Chronic Periodontitis

Treatments

Drug: Indocyanine green

Study type

Interventional

Funder types

Other

Identifiers

NCT04857346

KSU334

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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.