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ICG-PDT, Periimplantitis, Diabetes Mellitus

Primary Purpose

Peri-Implantitis

Status
Completed
Phase
Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
ICG-PDT
peri-implant mechanical debridement
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring photodynamic therapy*, periimplantitis*, diabetes mellitus*, indocyanine green*, photosensitizer*

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

  • Inclusion Criteria:

    • adult patients above 45 years of age having type 2 DM
    • HbA1c (≥6.5%) and fasting glucose test
    • probing depth ≥6 mm with bleeding and/or suppuration on at least one site around dental implants that remained in situ
    • On radiographic assessment, the implants exhibited ≥ 3 mm alveolar bone loss apical to the coronal region of the intraosteal portion of the dental implant.
  • Exclusion Criteria Patients were excluded if they indicated current or former history of tobacco smoking, any systemic disease other than DM, enrolled in a non-surgical periodontal maintenance program, history of implant repair, pregnancy, and part six months use of antimicrobials, non-steroidal anti-inflammatory drugs, bisphosphonates, or corticosteroids.

Sites / Locations

  • King Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Indocyanine green mediated photodynamic therapy (ICG-PDT)

Peri-implant mechanical debridement

Arm Description

Delivery of ICG solution at a concentration of 1 mg/mL will be used. The photosensitizer will be applied until the bottom of the peri-implant pocket using a 1 ml syringe. An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J will be used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction.

Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip.

Outcomes

Primary Outcome Measures

Bleeding on probing
Presence or absence of bleeding indicated as '1' or '0', respectively
Plaque index
Presence or absence of plaque indicated as '1' or '0', respectively.
Probing depth
Measurement of consecutive millimeter markings of the periodontal pocket depth
Suppuration
Presence or absence of pus
Crestal bone loss
Measurement of consecutive millimeter markings of the alveolar bone levels

Secondary Outcome Measures

Microbiological analysis (Porphyromonas gingivalis)
Bacterial viability from the peri-implant plaque
Microbiological analysis (Treponema denticola)
Bacterial viability from the peri-implant plaque
HbA1c
Assessment of serum HbA1c
Interleukin-1 beta
Assessment from peri-implant crevicular fluid
Interleukin-6
Assessment from peri-implant crevicular fluid

Full Information

First Posted
March 30, 2021
Last Updated
April 4, 2021
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT04833569
Brief Title
ICG-PDT, Periimplantitis, Diabetes Mellitus
Official Title
Clinical, Bacterial, and Inflammatory Outcomes of Indocyanine Green-mediated Photodynamic Therapy for Treating Periimplantitis Among Diabetic Patients: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
March 10, 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, the effect of photodynamic therapy (indocyanine green mediated) on the clinical, biological and inflammatory aspects was assessed in diabetic patients having peri-implantitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
photodynamic therapy*, periimplantitis*, diabetes mellitus*, indocyanine green*, photosensitizer*

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indocyanine green mediated photodynamic therapy (ICG-PDT)
Arm Type
Experimental
Arm Description
Delivery of ICG solution at a concentration of 1 mg/mL will be used. The photosensitizer will be applied until the bottom of the peri-implant pocket using a 1 ml syringe. An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J will be used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction.
Arm Title
Peri-implant mechanical debridement
Arm Type
Placebo Comparator
Arm Description
Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip.
Intervention Type
Biological
Intervention Name(s)
ICG-PDT
Intervention Description
An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J was used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction. The treatment was applied according to the manufacturer's recommendation. The PDT was performed by a single operator in all test patients
Intervention Type
Device
Intervention Name(s)
peri-implant mechanical debridement
Intervention Description
The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).
Primary Outcome Measure Information:
Title
Bleeding on probing
Description
Presence or absence of bleeding indicated as '1' or '0', respectively
Time Frame
6 months
Title
Plaque index
Description
Presence or absence of plaque indicated as '1' or '0', respectively.
Time Frame
6 months
Title
Probing depth
Description
Measurement of consecutive millimeter markings of the periodontal pocket depth
Time Frame
6 months
Title
Suppuration
Description
Presence or absence of pus
Time Frame
6 months
Title
Crestal bone loss
Description
Measurement of consecutive millimeter markings of the alveolar bone levels
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Microbiological analysis (Porphyromonas gingivalis)
Description
Bacterial viability from the peri-implant plaque
Time Frame
6 months
Title
Microbiological analysis (Treponema denticola)
Description
Bacterial viability from the peri-implant plaque
Time Frame
6 months
Title
HbA1c
Description
Assessment of serum HbA1c
Time Frame
6 months
Title
Interleukin-1 beta
Description
Assessment from peri-implant crevicular fluid
Time Frame
6 months
Title
Interleukin-6
Description
Assessment from peri-implant crevicular fluid
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adult patients above 45 years of age having type 2 DM HbA1c (≥6.5%) and fasting glucose test probing depth ≥6 mm with bleeding and/or suppuration on at least one site around dental implants that remained in situ On radiographic assessment, the implants exhibited ≥ 3 mm alveolar bone loss apical to the coronal region of the intraosteal portion of the dental implant. Exclusion Criteria Patients were excluded if they indicated current or former history of tobacco smoking, any systemic disease other than DM, enrolled in a non-surgical periodontal maintenance program, history of implant repair, pregnancy, and part six months use of antimicrobials, non-steroidal anti-inflammatory drugs, bisphosphonates, or corticosteroids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nawwaf Labban, BDS MSD PhD
Organizational Affiliation
Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Saud University
City
Riyadh
ZIP/Postal Code
11564
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
34033934
Citation
Labban N, Shibani NA, Al-Kattan R, Alfouzan AF, Binrayes A, Assery MK. Clinical, bacterial, and inflammatory outcomes of indocyanine green-mediated photodynamic therapy for treating periimplantitis among diabetic patients: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102350. doi: 10.1016/j.pdpdt.2021.102350. Epub 2021 May 24.
Results Reference
derived

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ICG-PDT, Periimplantitis, Diabetes Mellitus

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