Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus, Prediabetic State, Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Indocyanine green
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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.
Sites / Locations
- College of Applied Medical Sciences, King Saud University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Controlled Type 2 diabetes mellitus
Uncontrolled Type 2 diabetes melltius
Non-diabetic patients
Arm Description
Outcomes
Primary Outcome Measures
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.
Clinical attachment level
Clinical attachment level will be measured by adding recession with probing depth
Secondary Outcome Measures
Plaque scores
Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'
Bleeding on probing
Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'
Porphyromonas gingivalis
Presence or absence of bacteria from the plaque biofilms in the patient
Interleukin-6
Proinflammatory cytokine levels that will be quantified in the laboratory.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04857346
Brief Title
Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 12, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Prediabetic State, Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Controlled Type 2 diabetes mellitus
Arm Type
Experimental
Arm Title
Uncontrolled Type 2 diabetes melltius
Arm Type
Experimental
Arm Title
Non-diabetic patients
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Other Intervention Name(s)
Photodynamic therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Probing depth
Description
Probing depth will be measured to the nearest millimeter from the base of the periodontal pocket to the crest of the marginal gingiva.
Time Frame
6 months
Title
Clinical attachment level
Description
Clinical attachment level will be measured by adding recession with probing depth
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Plaque scores
Description
Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'
Time Frame
6 months
Title
Bleeding on probing
Description
Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'
Time Frame
6 months
Title
Porphyromonas gingivalis
Description
Presence or absence of bacteria from the plaque biofilms in the patient
Time Frame
6 months
Title
Interleukin-6
Description
Proinflammatory cytokine levels that will be quantified in the laboratory.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
College of Applied Medical Sciences, King Saud University
City
Riyadh
ZIP/Postal Code
11454
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34087466
Citation
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.
Results Reference
derived
Learn more about this trial
Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus
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