Protocol summary

Summary
The aim of the present study was to compare implant stability in two different techniques of implant bed preparation in type III and IV bone which is usually find in posterior maxilla. In this controlled randomized clinical trial, patients who were referred to Department of Implant and needed to replace posterior missing teeth of maxilla were selected. Subjects with systemic diseases, heavy smokers and those required bone graft were not included in the study. 54 ITI dental implants were placed in 26 patients. Participants were classified into 2 groups: The osteotome technique (29 implants) and conventional drilling ( 25 implants). Implant stability were assessed at 4 time intervals; baseline, 1,2 and 3 month after implant placement using Resonance Frequency Analysis(RFA) method with Osstell Device. Keyword: implant stability, osteotome, drilling, resonance frequency analysis

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201405274621N2
Registration date: 2014-06-08, 1393/03/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-08, 1393/03/18
Registrant information
Name
Rokhsareh Sadeghi
Name of organization / entity
Shahed Dental School
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9210
Email address
sadeghi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2012-01-31, 1390/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Implant Stability using Resonance Frequency Analysis between two different techniques of implant placement; Osteotome versus Conventional drilling: A controlled randomized clinical trial
Public title
The Comparison of Implant Stability between two different techniques of implant placement
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: posterior maxillary missing tooth / teeth; minimum; 8mm ridge height and 6mm width; good oral hygiene. Exclusion criteria: systemic diseases that affect host healing responses; Heavy smoking (more than 10 cigarette per day); need for bone grafting.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
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
Shahed University
Street address
Khalij-e- Fars Free way
City
Tehran
Postal code
Approval date
2008-06-22, 1387/04/02
Ethics committee reference number
174686

Health conditions studied

1

Description of health condition studied
implant placement in edentulus area
ICD-10 code
z96.5
ICD-10 code description
Presence of tooth-root and mandibular implants

Primary outcomes

1

Description
stability of dental implant
Timepoint
baseline (implant placement)-3 months
Method of measurement
ISQ value using resonance frequency analysis

Secondary outcomes

empty

Intervention groups

1

Description
inervention: using osteotome technique for implant placement
Category
Treatment - Surgery

2

Description
control group: use of conventional drilling for implant placement
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahed University, Dental School, Implant dept
Full name of responsible person
Dr.R.Sadeghi
Street address
Italia St., Vesal St., no. 39
City
Tehran

2

Recruitment center
Name of recruitment center
Tehran Uni. of Medical Sciences, Dental School, Implant Dept.
Full name of responsible person
Dr. A.R.Rokn
Street address
Resaerch center of dental school- Ghods St.- Keshavarz Blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University, Depuity of Research
Full name of responsible person
Dr. Z. Kiasalary
Street address
Khalij-e- Fars Free way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University, Depuity of Research
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
Shahed University
Full name of responsible person
Dr R Sadeghi
Position
assistant professor
Other areas of specialty/work
Street address
Italia St., Vesal St., no. 39
City
Tehran
Postal code
Phone
+98 21 8895 9210
Fax
Email
sadeghi@shahed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr R. Sadeghi
Position
speciaizled in periodontology
Other areas of specialty/work
Street address
Italia St., Vesal St., no 39
City
Tehran
Postal code
Phone
+98 21 8895 9210
Fax
Email
sadeghi@shahed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr R. Sadeghi
Position
Specialized in Periodontology- Assistant professor
Other areas of specialty/work
Street address
Italia St., Vesal St., no 39
City
Tehran
Postal code
Phone
+98 21 8895 9210
Fax
Email
sadeghi@shahed.ac.ir
Web page address
www.shahed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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