To assess the effect of subcrestal implant versus crestal implant on marginal bone loss
Design
This is a randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the drawing of lots to the intervention and control groups
Settings and conduct
This study will be performed in the School of Dentistry in Hamadan city on 28 eligible patients. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 20 to 70 years;
Candidate for dental implant;
Exclusion criteria:
Smoking;
Systemic disease of bone loss;
Uncontrolled diabetes;
Keratinized gums;
Uncontrolled periodontitis;
Intervention groups
Intervention group:
Placing subcortical implant one to two millimeters below the crest bone
Control group:
Placing cortical implant at the edge of the crest bone
Main outcome variables
Primary outcome:
Bone loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N415
Registration date:2022-01-10, 1400/10/20
Registration timing:prospective
Last update:2022-01-10, 1400/10/20
Update count:0
Registration date
2022-01-10, 1400/10/20
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
Expected recruitment start date
2022-01-26, 1400/11/06
Expected recruitment end date
2022-07-21, 1401/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of subcrestal implant versus crestal implant on marginal bone loss: a randomized clinical trial
Public title
Effect of subcrestal implant versus crestal implant on marginal bone loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 70 years;
Candidate for dental implant;
Exclusion criteria:
Smoking;
Systemic disease of bone loss;
Uncontrolled diabetes;
Keratinized gums;
Uncontrolled periodontitis;
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Not 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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-11-27, 1400/09/06
Ethics committee reference number
IR.UMSHA.REC.1400.694
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Bone loss
Timepoint
3 an 6 months after implant
Method of measurement
Through radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Placing subcortical implant one to two millimeters below the crest bone
Category
Treatment - Surgery
2
Description
Control group: Placing cortical implant at the edge of the crest bone
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Leila Shahsavand Baghdadi
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
shahsavand.leila@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Leila Shahsavand Baghdadi
Position
Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
shahsavand.leila@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Morad Hedayatipanah
Position
Periodontist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dr.hedayatipanah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available