Comparison of the effect of local Erythromycin versus local Gentamicin on the Kristal bone lesion around the dental implant: a double-blind randomized clinical trial
To compare the effect of local Erythromycin versus local Gentamicin on the Kristal bone lesion around the dental implant
Design
This is a double-blind randomized clinical trial, in which 30 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients who are the candidate for a dental implant and will refer to School of Dentistry in Mashhad City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 25 to 60 years;
Candidate for dental implant
Exclusion criteria:
Individuals without any teeth;
Immunodeficiency;
Diabetes;
Inflammation around the surgery location
Intervention groups
Intervention group 1: Erythromycin antibiotic ointment 0.5% single dose on the screw cover of dental implant
Intervention group 2: Gentamicin antibiotic ointment 0.3% single dose on the screw cover of dental implant
Main outcome variables
Assessing the Kristal bone lesion around the dental implant
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N262
Registration date:2019-02-12, 1397/11/23
Registration timing:registered_while_recruiting
Last update:2019-02-12, 1397/11/23
Update count:0
Registration date
2019-02-12, 1397/11/23
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
2018-12-22, 1397/10/01
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of local Erythromycin versus local Gentamicin on the Kristal bone lesion around the dental implant: a double-blind randomized clinical trial
Public title
Comparison of the effect of local Erythromycin versus local Gentamicin on the Kristal bone lesion around the dental implant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 25 to 60 years;
Candidate for dental implant
Exclusion criteria:
Individuals without any teeth;
Immunodeficiency;
Diabetes;
Inflammation around the surgery location
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
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)
Double blinded
Blinding description
The apparent shape of the ointments will be perfectly the same. Therefore, patients will be unaware of the type of intervention. In addition, the drugs will be given by the third person, therefore, the physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Mashhad University of Medical Sciences, Shahid Fakoori Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.090
Health conditions studied
1
Description of health condition studied
Dental implant failure
ICD-10 code
M27.69
ICD-10 code description
Other endosseous dental implant failure
Primary outcomes
1
Description
Assessing the Kristal bone lesion around the dental implant
Timepoint
Before surgery and 3 months after that
Method of measurement
Through phosphor plate radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Erythromycin antibiotic ointment 0.5% single dose on the screw cover of dental implant immediately after preparing implant
Category
Treatment - Drugs
2
Description
Intervention group 2: Gentamicin antibiotic ointment 0.3% single dose on the screw cover of dental implant immediately after preparing implant
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr Naser Sargolzaei
Street address
School of Dentistry, Mashhad University of Medical Sciences, Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
sargolzaien@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Shahid Fakoori Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
info.research@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Naser Sargolzaei
Position
Dental Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Mashhad University of Medical Sciences, Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
sargolzaien@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Naser Sargolzaei
Position
Dental Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Mashhad University of Medical Sciences, Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
sargolzaien@mums.ac.ir
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