Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus

Phase 2

Completed

• Conditions: Prediabetic State; Type 2 Diabetes Mellitus; Chronic Periodontitis
• Interventions: Drug: Indocyanine green

• Registration Number: NCT04857346
• Lead Sponsor: King Saud University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-12-12
• Study Completion: 2021-02-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-21
• Last Update Submitted: 2021-04-21
• Study First Posted: 2021-04-23
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uncontrolled Type 2 diabetes melltius	Indocyanine green	-
Controlled Type 2 diabetes mellitus	Indocyanine green	-
Non-diabetic patients	Indocyanine green	-

Primary Outcome Measures

Name	Time	Method
Clinical attachment level	6 months	Clinical attachment level will be measured by adding recession with probing depth
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.

Secondary Outcome Measures

Name	Time	Method
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.
Plaque scores	6 months	Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'

Trial Locations

Locations (1)

College of Applied Medical Sciences, King Saud University; 🇸🇦 Riyadh, Saudi Arabia