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The effect of Scaling with Photodynamic Therapy or Subgingival Irrigation with Chlorhexidine on IL-6 and IL-1B levels in patients with Peri-implantitis

Protocol summary

Study aim
To determine the effect of Scaling with Photodynamic Therapy using Diode Laser on the levels of Inflammatory Cytokines Interleukin-1 and Interleukin-6 in patients with Peri-implantitis, followed by its comparison to Scaling with Sublingual Irrigation using Chlorhexidine
Design
Single-blinded, parallel, randomized clinical trial with 66 participants divided into control and treatment groups using the sealed envelope randomization method.
Settings and conduct
Patients will be selected from those referring to the Implant Department, Faculty of Dentistry, Islamic Azad University of Tehran. This clinical trial will be single-blinded (the dentist who assesses the outcomes).
Participants/Inclusion and exclusion criteria
Partial Edentulous patients who are between 18 and 80 years old with healthy or treated periodontal conditions, in a maintenance care program, and have a 25 or less total plaque score. Presence of at least one implant with peri-implantitis that has been in function for at least one year; use of antibiotics or non-steroidal anti-inflammatory drugs, the presence of diseases that affect periodontal conditions, pregnant or lactating women, mobile implants, smoking.
Intervention groups
Intervention group: Scaling, Root Planing, and Mechanical Debridement of dental implants with Ti curettes + Photodynamic Therapy (320nm diode laser, 50mW, 90s continuously along with Methylene Blue 1% Photosensitiser; Photodynamic Therapy will be repeated 2 weeks later) + Chlorhexidine mouthwash Control group: Scaling, Root Planing, and Mechanical Debridement of dental implants with Ti curettes + Chlorhexidine (0.2%) irrigation with a blunt needle + Chlorhexidine mouthwash
Main outcome variables
Interleukin 1-b; Interleukin 6

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210212050339N1
Registration date: 2021-08-18, 1400/05/27
Registration timing: registered_while_recruiting

Last update: 2021-08-18, 1400/05/27
Update count: 0
Registration date
2021-08-18, 1400/05/27
Registrant information
Name
Pardis Hojjat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8808 3183
Email address
pardis.hojjat@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Scaling with Photodynamic Therapy or Subgingival Irrigation with Chlorhexidine on IL-6 and IL-1B levels in patients with Peri-implantitis
Public title
The Effect of Scaling with Photodynamic Therapy on IL-6 and IL-1B levels in patients with Peri-implantitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least one implant with peri-implantitis The implant has been in function for at least one year Screw-type implants with rough surface Partial edentulous patients with healthy or treated periodontal condition who are in maintenance care program. Total plaque score ≤ 25 18-80 years of age
Exclusion criteria:
Use of Antibacterial or Non-steroidal Anti-inflammatory drugs within 3 months prior to diagnosis Implant mobility Pregnancy or breastfeeding History of autoimmune diseases, malignancy, cardiovascular insufficiency, or acute diseases of other organs History of Peri-implantitis or Periodontal treatment in last 6 months Uncontrolled Diabetes (HbA1c > 7%) Tobacco use Use of Systemic Antibiotic Therapy for Prophylaxis of Endocarditis Infectious diseases such as HIV, TB and Hepatitis Failure to sign a written consent Those treated with any drugs which may affect soft tissue conditions; such as Phenytoin, Cyclosporine, etc. for 2 weeks or more in a month, before the initial evaluation. Head and neck radiotherapy Alcohol or drug abuse
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method will be used; at first, patients will be stratified according to their ages (above 50 and under 50), followed by random selection of a block size of 4 or 6, and afterwards, patients will be divided into treatment and control groups accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
The dentist performing the assessment will be blind to the patient group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Azad Tehran University of Medical Sciences
Street address
Unit B5-1, Sa'adi Tower, Hormozan Street, Shahrak-e-Gharb
City
Tehran
Province
Tehran
Postal code
1466764141
Approval date
2021-06-01, 1400/03/11
Ethics committee reference number
IR.IAU.DENTAL.REC.1400.028

Health conditions studied

1

Description of health condition studied
Peri-implantitis
ICD-10 code
M27.62
ICD-10 code description
Post-osseointegration biological failure of dental implant

Primary outcomes

1

Description
Interleukin 1-b Levels in Gingival Crevicular Fluid
Timepoint
At baseline, 3 months, and 6 months after treatment
Method of measurement
The Enzyme-linked Immunosorbent Assay test

2

Description
Interleukin 1-b Levels in Gingival Crevicular Fluid
Timepoint
At baseline, 3 months, and 6 months after treatment
Method of measurement
The Enzyme-linked Immunosorbent Assay test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Scaling, Root Planing, and Mechanical Debridement of dental implants with Ti curettes + Photodynamic Therapy (320nm diode laser, 50mW, 90s continuously along with Methylene Blue 1% Photosensitiser; Photodynamic Therapy will be repeated 2 weeks later) + Chlorhexidine mouthwash
Category
Treatment - Other

2

Description
Control group: Scaling, Root Planing, and Mechanical Debridement of dental implants with Ti curettes + Chlorhexidine (0.2%) irrigation with a blunt needle + Chlorhexidine mouthwash
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Tehran Dental Branch
Full name of responsible person
Nasrin Esfahanizadeh
Street address
No. 9, 9th Neyestan St., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
n_esfahanizadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No. 9, 9th Neyestan St., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
pardis.hojjat@yahoo.com
Web page address
http://dental.iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nasrin Esfahanizadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan St., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
n_esfahanizadeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nasrin Esfahanizadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan St., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
n_esfahanizadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pardis Hojjat
Position
Dentistry resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan St., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
pardis.hojjat@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Collected data after de identification is available to share.
When the data will become available and for how long
6 months after publication
To whom data/document is available
People working in academic institutions.
Under which criteria data/document could be used
Statistical analysis of data is allowed after applicator presents required credentials for working in academic institutions
From where data/document is obtainable
Via contacting : n_esfahanizadeh@yahoo.com
What processes are involved for a request to access data/document
Sending credentials to mentioned e-mail
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