An evaluation to compare peri-implant crevicular fluid cytokine level using intact manufacturer or reused healing abutments: A controlled clinical trial
Comparison of cytokine levels in Peri-implant Crevicular Fluid using intact or reused healing abutments
Design
This study is a phase 3 parallel double-blind clinical trial. 50 qualified individuals will be included in the study. The sampling is done by convenience sampling method. For the first ten percent of the sample size, patients are divided into two study groups by using a coin as the method of distribution. Minimization sampling method will be used to divide the rest of patients into study groups.
Settings and conduct
Place of study: School of dentistry
How to do: A double-blind clinical trial
Blind Mode: None of the patient and dentist side and data researcher and analyst knows the allocation of groups to individuals.
Participants/Inclusion and exclusion criteria
inclusion criteria: Age over 18 years old; One-stage Implant placement should be performed Exclusion criteria: Smoking; immunosuppressive drugs and antibiotics intake; The presence of periodontal disease.
Intervention groups
Group 1: Intervention with an intact healing abutment
Group II: Intervention with a reused healing abutment
Main outcome variables
IL-1β and TNF-α cytokine level in the peri-implant crevicular fluid using an intact healing abutment; IL-1β and TNF-α cytokine level in the peri-implant crevicular fluid using a reused healing abutment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160315027056N2
Registration date:2019-08-11, 1398/05/20
Registration timing:retrospective
Last update:2019-08-11, 1398/05/20
Update count:0
Registration date
2019-08-11, 1398/05/20
Registrant information
Name
Nazila Lashkarizadeh
Name of organization / entity
Kerman university of medical sciences, Dental school
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9021
Email address
n_lashkari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-05, 1398/01/16
Expected recruitment end date
2019-07-07, 1398/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An evaluation to compare peri-implant crevicular fluid cytokine level using intact manufacturer or reused healing abutments: A controlled clinical trial
Public title
peri-implant crevicular fluid cytokine level using healing abutments
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of the patient should be over 18
Implant treatment should be performed in patients with partial or complete edentulous
Bone level implant placement in one stage and obtaining suitable primary stability should be possible.
Good patient compliance, reference for follow-up visits and observation of post operation instructions should also be possible.
Exclusion criteria:
Patients who have periodontal disease
Conditions that affect the immune system such as diabetes and pregnancy
The habit of smoking and alcohol or tobacco consumption
History of Antibiotics, anti-inflammatory, and immunosuppressive drugs intake three months before the study.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
1
Sampling is done in such a way that two months after the implant placement, the Peri-implant Crevicular fluid from each used or intact healing abutments connected to the implants of each patient is collected in a sample tube. Then the samples will be assessed for cytokine level.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding process is in such a way that the healing abutment connection to implant is done by the corresponding surgeon while the patient is completely unaware of the types of healing abutments. After 2 months, all measurements and peri-implant crevicular fluid sampling from implants are done by one experienced dentist, who is unaware of the types of healing abutments. Based on the patient and implant placement area, a number is assigned to each sampling tube. This way, the person responsible for conducting the ELISA test is also unaware of the types of samples. All clinical measurements are done by the corresponding dentist and are recorded in the patient form by the dentist assistant. Finally, the gathered information is divided into two groups and presented to the person in charge of performing statistical tests who is unaware of each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Ethics Committee, Vice Chancellor for Research and Technology of University of Medical Sciences Building, First of Ebne Sina Street, Jahad Boulevard, Sommaye Cross road, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Approval date
2019-05-29, 1398/03/08
Ethics committee reference number
IR.KMU.REC.1398.067
Health conditions studied
1
Description of health condition studied
Peri-implant mucositis
ICD-10 code
Z96.5
ICD-10 code description
Presence of tooth-root and mandibular implants
Primary outcomes
1
Description
Interleukin-1β cytokine
Timepoint
Two months after the intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) human kits (HANGZHOU EASTBIOPHARM CO.LTD.) for evaluation of interleukin 1β levels
2
Description
Tumor Necrotizing Factor α cytokine
Timepoint
Two months after the intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) human kits (HANGZHOU EASTBIOPHARM CO.LTD.) for evaluation of interleukin 1β levels
Secondary outcomes
1
Description
Plaque Index (Ainamo & Bay 1975)
Timepoint
2 months after the intervention
Method of measurement
Observation in such a way that if the plaque is visible on each of the buccal, lingual, mesial or distal surface of healing abutment 0 code and if it is not visible code 1 is assigned.
2
Description
Bleeding Index (Ainamo & Bay)
Timepoint
2 months after the intervention
Method of measurement
Observation in such a way that if bleeding on probing is visible on each of the buccal, lingual, mesial or distal surface of healing abutment 0 code and if it is not visible code 1 is assigned.
Intervention groups
1
Description
Intervention group: The group in which reused healing abutment (Dio Pars.Co) is attached to the implant.
Category
Treatment - Devices
2
Description
Control group: The group in which intact manufacturer healing abutment is attached to the implant.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Keman school of dentistry, Periodontology department
Full name of responsible person
Nazila Lashkarizadeh assistant professor in Periodontology department
Street address
Periodontology department, School of dentistry, End of Shafa street, Jomhoori Eslami Boulevard, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9022
Fax
+98 34 3211 9028
Email
n_lashkari@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Vice Chancellor for Research and Technology of University of Medical Sciences Building, First of Ebne Sina Street, Jahad Boulevard, Sommaye Cross road, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3226 3787
Email
kmu_research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Kerman University of Medical Sciences
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
Kerman University of Medical Sciences
Full name of responsible person
Nazila Lashkarizadeh
Position
Specialist in periodontics, Assistant professor in periodontics department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontology department, Dental school, End of Shafa street, Jomhoori Eslami Boulevard, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
nazilalashkarizadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nazila Lashkarizadeh
Position
Specialist in periodontics, Assistant professor in periodontics department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontology department, Dental school, End of Shafa street, Jomhoori Eslami Boulevard, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9023
Email
nazilalashkarizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nazila Lashkarizadeh
Position
Specialist in periodontics, Assistant professor in periodontics department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontology department, Dental school, End of Shafa street, Jomhoori Eslami Boulevard, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9022
Email
nazilashkarizadeh@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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the study will be reported without mentioning patient information
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific research centers
Under which criteria data/document could be used
In order to do the same study, or to apply in industry
From where data/document is obtainable
Please email the person responsible for answering
nazilalashkarizadeh@yahoo.com
What processes are involved for a request to access data/document
In the case of doing researches, the proposal, the reason for the need for the data and name of the research supporting organization should be sent to the email. If industrial companies are the applicant for the research data they should send the purpose and required documents for the originality of the company to the email mentioned.