The effect of photodynamic therapy with indocyanine green photosensitizer on nonsurgical management of peri-implant diseases and the periodontopathic bacteria
The aim of this single blind randomized clinical study is to assess the effect of photodynamic therapy using Indocyanin green as a photosensitizer on non-surgical treatment of peri-implant mucosal inflammation from the clinical point of view and it’s periopathogenic bacteria in vivo. this single blind randomized study is done on the samples selected from the patients referring to the Periodontology department of dental faculty of Tabriz University of Medical Sciences between November 2016 and March 2017.
The inclusion criteria are described as following:
1) Implants with severe peri-implant mucositis or mild peri-implantitis
2) Presence of at least ONE implant with at least ONE year in function.
The patients with the following conditions are excluded from the study:
1) Any intervention for treatment of peri-implant disease in the last three months
2) Smokers.
25 patients in each group (50 patients) will attend the study. Patients will randomly assign in to two groups with the flip of coin. Control group will receive mechanical debridement (using ultrasonic devices under local anesthesia) and the test group will receive photodynamic therapy with Indocyanine green photosensitizer(intervention) just after the mechanical debridement. Primary and secondary outcomes will be assessed after two weeks, one and 3 months.
Primary outcome in this study is bleeding on Probing.
Secondary outcomes are pocket depth, pain on probing, clinical attachment level and common microorganisms around implants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610211248N4
Registration date:2017-02-10, 1395/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Reza Pourabbas
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 9338
Email address
pourabbas@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-10-15, 1395/07/24
Expected recruitment end date
2017-10-16, 1396/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of photodynamic therapy with indocyanine green photosensitizer on nonsurgical management of peri-implant diseases and the periodontopathic bacteria
Public title
The effects of laser assisted disinfection treatments on peri-implant disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least 18 years old; Presence of at least ONE implant with at least ONE year in function ;Presence of Peri- implant disease ( severe peri-implant mucositis or mild peri- implantitis which is placed in ISI class II, III and IVaccording to theKadkhodazade and Amid classification with a positive bleeding on probing, probing depth of 4 mm or more,no soft tissue loss with or without bone loss of 2mm or less in periapical radiographs)
Exclusion Criteria:Using antibiotic from 3 months prior to study ; Using NSAIDS and/or corticosteroids at the recent 3 months, ;Presence of any history of any treatment for peri- implant disease during last 3 months ;Being a current and/or former smokers , drug or alcohol abuser ; Using Bisphosphonates, Cyclosporine, Coumadin, Warfarin and Heparin ;Pregnancy and lactation; Presence of an active periodontal disease after therapy ;Presence of poorly controlled diabetes and other debilitating diseases ;Refraining to sign the consent form
Age
From 18 years old to 120 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Daneshgah Ave.
City
Tabriz
Postal code
Approval date
2016-09-26, 1395/07/05
Ethics committee reference number
IR.TBZMED.REC.1395.681
Health conditions studied
1
Description of health condition studied
Peri-implant disease
ICD-10 code
Z96.5, K05
ICD-10 code description
Presence of tooth-root and mandibular implants, Gingivitis and periodontal diseases
Primary outcomes
1
Description
Bleeding on Probing
Timepoint
2 weeks, 1 mounths,3 months
Method of measurement
Clinical Examination
Secondary outcomes
1
Description
probing depth
Timepoint
2weeks,1month and 3 months
Method of measurement
clinical and laboratory assessment
2
Description
clinical attachment level
Timepoint
2weeks,1month and 3 months
Method of measurement
clinical examination
3
Description
Pain on Probing
Timepoint
2weeks,1month and 3 months
Method of measurement
clinical examination
4
Description
common microorganisms
Timepoint
2weeks,1month and 3 months
Method of measurement
laboratory assessment
Intervention groups
1
Description
The affected sites will be debrided mechanically using ultrasonic devices under local anesthesia. Consequently, a photosensitizer agent ( Indocyanine green) will be inserted into peri-implant pockets by a gauge 21 round-tip needle for 30 seconds followed by illumination with laser beam (980 nm/ 0.5 watts) for 30 seconds.The patient will be instructed to avoid intake of any food/beverages for 2 hours.
Category
Treatment - Other
2
Description
The affected sites will be debrided mechanically using ultrasonic devices under local anesthesia. The patient will be instructed to avoid intake of any food/beverages for 2 hours.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reza Pourabbas
Street address
Daneshgah Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Daneshgah Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Reza Pourabbas
Position
Professor
Other areas of specialty/work
Street address
Daneshgah Ave.
City
Tabriz
Postal code
Phone
+98 41 3328 1190
Fax
Email
rpourabbas@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Reza Pourabbas
Position
Professor/ DDS,Ms
Other areas of specialty/work
Street address
Daneshgah Ave.
City
Tabriz
Postal code
Phone
+98 41 3328 1190
Fax
Email
rpourabbas@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Reza Pourabbas
Position
Professor
Other areas of specialty/work
Street address
Daneshgah Ave.
City
Tabriz
Postal code
Phone
+98 33281190
Fax
Email
rpourabbas@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)