ICG-PDT, Periimplantitis, Diabetes Mellitus

NCT ID: NCT04833569

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-20

Study Completion Date

2021-03-10

Brief Summary

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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

Detailed Description

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Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Indocyanine green mediated photodynamic therapy (ICG-PDT)

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.

Group Type EXPERIMENTAL

ICG-PDT

Intervention Type BIOLOGICAL

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

peri-implant mechanical debridement

Intervention Type DEVICE

The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).

Peri-implant mechanical debridement

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

Group Type PLACEBO_COMPARATOR

peri-implant mechanical debridement

Intervention Type DEVICE

The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).

Interventions

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ICG-PDT

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 BIOLOGICAL

peri-implant mechanical debridement

The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Saud University

OTHER

Sponsor Role lead

Responsible Party

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Labban Nawwaf

Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nawwaf Labban, BDS MSD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University

Locations

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King Saud University

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type DERIVED
PMID: 34033934 (View on PubMed)

Other Identifiers

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KingSaud

Identifier Type: -

Identifier Source: org_study_id

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