Comparison of effect of abutment removal and reconnection on increasing inflammatory factors around dental implants in multi-unit abutment with conventional abutment
The aim of this study is evaluation of inflammatory cytokines, IL6 and IL1β in gingival crevicular fluid of implants in two methods of making a standard implant (impression in fixture level) and a new protocol (impression in Multi-unit abutment surface). All patients with implant that referred to prosthesis specialist private office, in the June up to August 2016 exanimate about implant success and patient with implants according to inclusion criteria will participated to one of the two study groups (25 person in each group).
Study was clinical trial (split-mouth) and one side blind and making of dental implant prosthesis in one side of the jaw done by multi-unit abutment and in another side healing abutment put on implant and impression is done on the fixture surface. On the side that the healing abutment was used, abutment will opened and closed at least three times. Samples are achieved from peri- implant sulcus and paper points are intered to four specific areas (mesiobuccal, distobuccal, mesiolingual and distolingual) for gingival crevicular fluid sampling until modest resistance will be felt and will be kept there for 30 seconds. Any paper point placed inside a small sterile tube and then are frozen in -80 `C until all samples are collected. Proinflammatory cytokines of IL6 and IL1β will be measured in the Immunology laboratory by ELISA kit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071120488N2
Registration date:2016-08-15, 1395/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-15, 1395/05/25
Registrant information
Name
Ramin Negahdari
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 607 0035
Email address
negahdarir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Expected recruitment start date
2016-05-31, 1395/03/11
Expected recruitment end date
2016-08-03, 1395/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of abutment removal and reconnection on increasing inflammatory factors around dental implants in multi-unit abutment with conventional abutment
Public title
Comparison of effect of abutment removal and reconnection on increasing inflammatory factors around dental implants in multi-unit abutment with conventional abutment
Purpose
Prevention
Inclusion/Exclusion criteria
• Inclusion criteria of the study:
Having informed consent for inclusion to study; Having at least two units of the posterior dental titanium implants in two-sided at the same jaw; Putting implants under two-stage process that demands exposure in the second stage of surgery; Having at least 2 mm attached gingiva around the implant; 5.Maximum thickness of gingiva in the neck of the implant to be 3 mm; Having at least 18 years-old
• Exclusion criteria of the study:
Scaling and Root planning in the past three months; People who need bone augmentation and with periodontitis; People who underwent radiotherapy within the past year in the head and neck areas; Pregnant women and nursing mothers; Patients receiving antibiotics in the past 6 months; Having any systemic diseases like diabetes that affect on oral health; Drug addiction, smoking or alcohol; A history of the use of the bisphosphonates; Taking systemic anti-inflammatory medications
Age
From 18 years old to 139 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz-Golgasht St.
City
Tabriz
Postal code
Approval date
2016-07-19, 1395/04/29
Ethics committee reference number
IR.TBZMED.REC.1395.302
Health conditions studied
1
Description of health condition studied
implantitis
ICD-10 code
T85.9
ICD-10 code description
Unspecified complication of internal prosthetic device, implant and graft
Primary outcomes
1
Description
IL6 - IL1β
Timepoint
befor intervention- 4 month after intervention
Method of measurement
ELISA Kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1:
In on side multi-unit abutment will be used.
Category
Treatment - Devices
2
Description
Intervention2:
In another side, common abutment will be used.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Private office of prosthesis specialist
Full name of responsible person
Street address
Daneshgah square
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology
Full name of responsible person
Sarvar Alipur
Street address
Thir floor, Central building of number 2, Golgasht street, Tabriz
City
Tabriz
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
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 Ramin Negahdari
Position
Phd in prosthodontics
Other areas of specialty/work
Street address
dentistry faculty, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3440 9387
Fax
Email
negahdarir@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Ramin Negahdari
Position
Phd in prosthodontics
Other areas of specialty/work
Street address
Dentistry faculty, Golgasht street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3440 9387
Fax
Email
negahdarir@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Ebrahim Taghavi
Position
Other areas of specialty/work
Street address
Dentistry faculty, Golgasht street, Tabriz
City
tabriz
Postal code
Phone
+41 33344280
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)