Comparison the effect of two different heights of implant collar on the marginal bone loss in patients who are candidate for immediate implantation: a randomized clinical trial
Objectives: To assess the effect of two different heights of implant collar on the marginal bone loss in patients who are candidate for immediate implantation
Design: A randomized clinical trial.
Setting and conduct: The eligible patients who are candidate for immediate implantation who will refer to School of Dentistry during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 65 years; indications for immediate implant placement, bone quality D2; presence of every 4 walls of the alveolar bone, presence of at least 4 mm bone beyond the apex of the root, a at least 3 mm attached gingiva width.
Exclusion criteria: Systemic disease; coagulopathy disorders; acute infection around alveolar bone; heavy smoker; using alcohol or opioid; bruxism; presence of dehiscence and fenestration in the remaining bone walls.
Intervention group 1: Placement of implants collar with a diameter of 4 mm and a length of 12 mm.
Intervention group 2: Placement of implants collar with a diameter of 4 mm and a length of 11 mm.
Primary outcome: (a) assessing implant survival 1 and 3 and 6 months after intervention through physical examination; (b) assessing the location of implant placement before intervention and 6 months later through radiography.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705309014N166
Registration date:2017-06-05, 1396/03/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-05, 1396/03/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two different heights of implant collar on the marginal bone loss in patients who are candidate for immediate implantation: a randomized clinical trial
Public title
Comparison the effect of two different heights of implant collar on the marginal bone loss in patients who are candidate for immediate implantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; indications for immediate implant placement, bone quality D2; presence of every 4 walls of the alveolar bone, presence of at least 4 mm bone beyond the apex of the root, a at least 3 mm attached gingiva width.
Exclusion criteria: Systemic disease; coagulopathy disorders; acute infection around alveolar bone; heavy smoker; using alcohol or opioid; bruxism; presence of dehiscence and fenestration in the remaining bone walls.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.UMSHA.REC.1395.485
Health conditions studied
1
Description of health condition studied
Immediate implantation
ICD-10 code
Z96.9
ICD-10 code description
Presence of functional implant, unspecified
Primary outcomes
1
Description
assessing implant survival
Timepoint
1 and 3 and 6 months after intervention
Method of measurement
through physical examination
2
Description
assessing the location of implant placement
Timepoint
before intervention and 6 months later
Method of measurement
through radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Placement of implants collar with a diameter of 4 mm and a length of 12 mm.
Category
Treatment - Devices
2
Description
Intervention group 2: Placement of implants collar with a diameter of 4 mm and a length of 11 mm.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr Masoomeh Khoshhal
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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, Hamadan 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
School of Dentistry
Full name of responsible person
Dr Masoomeh Khoshhal
Position
Periodontist
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
khoshhalsepideh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Masoomeh Khoshhal
Position
Periodontist
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
khoshhalsepideh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)