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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- King Saud University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Clinical attachment level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Controlled Type 2 diabetes mellitus
Intervention: Indocyanine green (Drug)
Uncontrolled Type 2 diabetes melltius
Intervention: Indocyanine green (Drug)
Non-diabetic patients
Intervention: Indocyanine green (Drug)
Outcomes
Primary Outcomes
Clinical attachment level
Time Frame: 6 months
Clinical attachment level will be measured by adding recession with probing depth
Probing depth
Time Frame: 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 Outcomes
- Bleeding on probing(6 months)
- Porphyromonas gingivalis(6 months)
- Interleukin-6(6 months)
- Plaque scores(6 months)
Investigators
Mohammed Mahmoud Al-Momani
Professor
King Saud University