Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04857346
• Other study ID #: KSU334
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: April 2021
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 1, 2021
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontitis
• Prediabetic State
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Indocyanine 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.

Locations

Country	Name	City	State
Saudi Arabia	College of Applied Medical Sciences, King Saud University	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Clinical attachment level	Clinical attachment level will be measured by adding recession with probing depth	6 months
Secondary	Plaque scores	Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'	6 months
Secondary	Bleeding on probing	Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'	6 months
Secondary	Porphyromonas gingivalis	Presence or absence of bacteria from the plaque biofilms in the patient	6 months
Secondary	Interleukin-6	Proinflammatory cytokine levels that will be quantified in the laboratory.	6 months