The comparison of tapered versus cylindrical implants in post-operative pain amount after dental implant surgery in posterior maxilla.
Design
The randomized triple-blinded single center clinical trial with parallel groups, without the placebo.
Sample size: 60 patients
Randomization method: A concealed simple randomization with randomized numbers table.
Settings and conduct
Setting and conduct of the trial: Oral and maxillofacial surgery department of mashhad dental school.
Blinding:The participants (patients), investigator who collects data and assessors the outcome and who analyses the data would be blind to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The age between 20-50 years old, the healthy systemic physical status (ASA I,II) without the history of analgesic and sedative drugs in the past 1 year, candidate for 1 or 2 units implantation in posterior maxilla regionٍ, existing the sufficient bone width and height in posterior maxilla region and lack of need for bone graft and sinus lift during implantation
ٍExclusion criteria:
Patients who would not attend for follow up sessions and arbitrary usage of analgesic drugs except Gelofen by patients, because of intolerable severe pain
Intervention groups
Intervention group 1:Tapered implant
Intervention group 2:Cylindrical implant
No control group
Main outcome variables
Main outcome: Postoperative pain amount after implant surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150613022697N4
Registration date:2018-06-16, 1397/03/26
Registration timing:prospective
Last update:2018-06-16, 1397/03/26
Update count:0
Registration date
2018-06-16, 1397/03/26
Registrant information
Name
Sahand Samiee rad
Name of organization / entity
mashhad dental school,oral and maxillofacial department
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 7289
Email address
samieerads@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of tapered versus cylindrical implants in post-operative pain amount after dental implant surgery in posterior maxilla.
Public title
Post-operative pain amount in tapered versus cylindrical implants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age between 20-50 years old
The healthy systemic physical status (ASA I,II)
Without the history of analgesic and sedative drugs in the past 1 year.
Candidates for 1 or 2 units implantation in posterior maxilla region
Existing the sufficient bone width and height in posterior maxilla region
lack of need for bone graft and sinus lift during implantation
Exclusion criteria:
Patients who would not attend for follow up sessions.
The arbitrary usage of analgesic drugs except Gelofen by patients, because of intolerable severe pain.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
ُSimple individual randomization using the table of random numbers would be used.
Allocation concealment of random codes would be carried out.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants (patients), investigator who collects data and assessors the outcome and the statistician who will analyse the data would be blind to the study.
the patients who participated in this study do not know which kind of same size implants whether cylindrical or taper would be used for them.
the pain assessor would be another surgeon who is blind to the study.
Placebo
Not used
Assignment
Parallel
Other design features
The randomized triple blind clinical trial without the placebo
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Ghoreishi building, Daneshghah avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.007
Health conditions studied
1
Description of health condition studied
Dental implant surgery
ICD-10 code
M27.69
ICD-10 code description
Other endosseous dental implant failure
2
Description of health condition studied
Post-operative pain
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
The post-operative pain amount
Timepoint
In 3,6 and 12 hours after the surgery and also in 1,2,3 and 7 days post-operatively.
Method of measurement
The score of 0 to 10 by VAS system (Visual Analog Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Tapered implant with 4mm diameter from Biohorizone system which needs drilling regarding the tapered system protocol.
Category
Treatment - Surgery
2
Description
Intervention group 2: Cylindrical implant with 4mm diameter from Biohorizone system which needs drilling regarding the straight system protocol.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and maxillofacial surgery department, Mashhad dental school.
Full name of responsible person
Sahand Samiee rad
Street address
Vakil abad street, Mashhad dental school
City
Mashhad
Province
Razavi Khorasan
Postal code
9176813111
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
samieerads@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Saeed Eslami
Street address
Ghoreishi building, Daneshghah avenue.
City
Mashhad
Province
Razavi Khorasan
Postal code
91779448959
Phone
+98 51 3841 2081
Fax
+98 51 3841 2081
Email
eslamis@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
Private
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
Sahand Samiee rad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176813111
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
samieerads@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sahand Samiee rad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad dental school, Vakil abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176813111
Phone
+98 51 3883 7289
Fax
+98 51 3882 9525
Email
samieerads@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Barat Shaban
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad dental school, Vakil abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
shabanb@mums.ac.ir
Web page address
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
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deindetified data would be shared for all researchers.
When the data will become available and for how long
The access to data will be started 6 months after publication.
To whom data/document is available
The data would only be available for people working in academic institutions.
Under which criteria data/document could be used
It is allowed to use the data for meta-analysis and systematic reviews.
From where data/document is obtainable
The data can be obtained via email, from the corresponding researches (Dr Sahand samiee rad).
E-mail: samieerads@mums.ac.ir
What processes are involved for a request to access data/document
The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission.