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Completed

NCT Number: NCT04857346

Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Chronic Disease Chronic Periodontitis Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Prediabetic State Stomatognathic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

College of Applied Medical Sciences, King Saud University

Riyadh, 11454, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indocyanine green

Drug

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.

Other names: Photodynamic therapy

Primary outcomes

  1. 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.

  2. Clinical attachment level

    Time frame: 6 months

    Clinical attachment level will be measured by adding recession with probing depth

Secondary outcomes

  1. Plaque scores

    Time frame: 6 months

    Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'

  2. Bleeding on probing

    Time frame: 6 months

    Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'

  3. Porphyromonas gingivalis

    Time frame: 6 months

    Presence or absence of bacteria from the plaque biofilms in the patient

  4. Interleukin-6

    Time frame: 6 months

    Proinflammatory cytokine levels that will be quantified in the laboratory.

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 23, 2021
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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