Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus

NCT04857346 | Completed Phase 2

• 1 other identifier: KSU334
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Prediabetic State; Chronic Periodontitis

Outcome Measures

Primary Outcomes (2)

• 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

• Clinical attachment level

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

  6 months

Secondary Outcomes (4)

• Plaque scores

  6 months

• Bleeding on probing

  6 months

• Porphyromonas gingivalis

  6 months

• Interleukin-6

  6 months

Study Arms (3)

Controlled Type 2 diabetes mellitus

EXPERIMENTAL

Drug: Indocyanine green

Uncontrolled Type 2 diabetes melltius

EXPERIMENTAL

Drug: Indocyanine green

Non-diabetic patients

ACTIVE COMPARATOR

Drug: Indocyanine green

Interventions

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.

Also known as: Photodynamic therapy

Controlled Type 2 diabetes mellitus; Non-diabetic patients; Uncontrolled Type 2 diabetes melltius

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

College of Applied Medical Sciences, King Saud University

Riyadh, 11454, Saudi Arabia

Location

Related Publications (1)

• Al-Momani MM. Indocyanine-mediated antimicrobial photodynamic therapy promotes superior clinical effects in stage III and grade C chronic periodontitis among controlled and uncontrolled diabetes mellitus: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102379. doi: 10.1016/j.pdpdt.2021.102379. Epub 2021 Jun 1.

  PMID: 34087466 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Chronic Periodontitis

Interventions

Indocyanine Green; Photochemotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 23, 2021
• Study Start: June 1, 2020
• Primary Completion: December 12, 2020
• Study Completion: February 1, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

SA (1)