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Clinical Effects of Mechanical Debridement with Adjunctive Photodynamic Therapy or Chlorhexidine Irrigation in patients with Peri-implantitis: a Randomized Clinical Trial

Protocol summary

Study aim
evaluating the Clinical effects of mechanical debridement with adjunctive photodynamic therapy or chlorhexidine irrigation in peri implantitis
Design
single blind,parallel, randomized clinical trial with 26 participants divided in control and treatment groups with sealed envelope randomization method.
Settings and conduct
patients will be selected from those referring to implant department, faculty of dentistry, islamic azad university of tehran this clinical trial will be single blinded(patients)
Participants/Inclusion and exclusion criteria
inclusion criteria: 18-80 years of age, presence of at least one site with peri implantitis and screw type implants with rough surface which had been in function for at least 1 year exclusion criteria: usage of antibiotics or NSAIDs in last 3 months, implant mobility, pregnancy or nursing, history of peri implantitis or periodontal treatment in last 6 months, uncontrolled diabetes, tobacco use and history of autoimmune diseases, malignancy, cardiovascular insufficiency or acute diseases of other organs
Intervention groups
Periodontal treatment comprising scaling and root planing (SRP) and cleaning of the implant surfaces with prophylaxis brush and paste will be accomplished for each patient. 2 weeks after SRP, clinical indices will be recorded and patients will be randomly divided into two groups and treated with photodynamic therapy(810nm diode laser,0.3 W, 90s with indocyanine green) or chlorhexidine irrigation(control) with blunt needle. 2 weeks later these treatments will be repeated for control and treatment groups. chlorhexidine mouthwash(0.2%, 2 times per day and each time 10ml) will be prescribed for both groups for 4 weeks. clinical indices will be evaluated at 1,3 and 6 month after treatment.
Main outcome variables
probing pocket depth(PPD), clinical attachment loss(CAL), papillary bleeding index(PBI) and Plaque index (modified mombelli)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201021049104N1
Registration date: 2020-11-06, 1399/08/16
Registration timing: prospective

Last update: 2020-11-06, 1399/08/16
Update count: 0
Registration date
2020-11-06, 1399/08/16
Registrant information
Name
Ali Zareey
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7740 8848
Email address
ali76_zareey@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Effects of Mechanical Debridement with Adjunctive Photodynamic Therapy or Chlorhexidine Irrigation in patients with Peri-implantitis: a Randomized Clinical Trial
Public title
Clinical Effects of Photodynamic Therapy in Peri-implantitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-80 years of age Presence of at least one site with peri-implantitis (PPD≥ 6mm, MBL≥3 mm and bleeding/suppuration on probing) At least 1 year of function in implants Screw type implants with rough surface
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
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method will be used; at first, patients will be stratified based on age(above 50 and under 50) and then a block size of 4 or 6 will be selected randomly and patients will be divided into treatment and control groups based on that.
Blinding (investigator's opinion)
Single blinded
Blinding description
the participants in this clinical trial do not know if they are receiving the adjunctive photodynamic therapy or chlorhexidine irrigation
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Tehran
Street address
No. 9, 9th Neyestan St. , Pasdaran Ave. , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.192

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
Probing pocket depth(PPD)
Timepoint
at baseline, 2 weeks,1,3 and 6 month after treatment
Method of measurement
plastic probe

2

Description
Clinical attachment loss(CAL)
Timepoint
at baseline, 2 weeks,1,3 and 6 month after treatment
Method of measurement
plastic probe

3

Description
Papillary bleeding index(PBI)
Timepoint
at baseline, 2 weeks,1,3 and 6 month after treatment
Method of measurement
Observation of papillary bleeding pattern

4

Description
Modified mombelli plaque index(mPI)
Timepoint
at baseline, 2 weeks,1,3 and 6 month after treatment
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Scaling and root planing and mechanical debridement of dental implants with Ti curettes+ Photodynamic therapy (810 nm diode laser,0.3W, 90s continuous and with indocyanine green photosensitizer; photodynamic therapy will be repeated 2 weeks later)+ chlorhexidine mouthwash
Category
Treatment - Other

2

Description
Control group: Scaling and 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
ali76_zareey@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
ali zareey
Position
dentistry student
Latest degree
A Level or less
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
ali76_zareey@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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