Aim: Comparison of implant stability and radiographic crestal bone loss between HA/coated and RBM short Dentis implants in patients with edentulism in posterior maxilla.
Study Design: Interventional; Single Blind; Uni-center; 2-3 trial phase.
population: With age limit; no sex limit.
Inclusion criteria: Patients with range of 20-65 years old; Plaque index 25% or less before surgery; Presence of 2 edentulous area adjacent or counterpart; At least 9mm crestal bone height to maxillary sinus floor; At least 6mm bone width; Insertion torque between 20-50 Ncm.
Exclusion criteria: Patients with any infectious or systemic diseases; smokers; history or presence of periodontitis; Fresh Socket Implantation; Need of supplemental surgery such as ridge splitting and ridge augmentation.
b- Intervention: Placement of Dentis HA coated implants.
Control: Placement of Dentis RBM implants.
Time of intervention: 6 months.
Primary or under study outcome measures: Perio test value; Radiographic crestal bone loss.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101611134N1
Registration date:2013-01-30, 1391/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-30, 1391/11/11
Registrant information
Name
Nasim Farkhani
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan)
Country
Iran (Islamic Republic of)
Phone
+98 31 1260 1550
Email address
n.farkhani@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-11-05, 1391/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Implant Stability and Radiographic Crestal Bone Loss Between HA/coated and RBM Short Dentis Implants in Posterior Maxilla
Public title
Implant Stability and Radiographic Crestal Bone Loss Between HA/coated and RBM Short Dentis Implants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with range of 20-65 years old; Plaque index 25% or less before surgery; Presence of 2 edentulous area adjacent or counterpart; At least 9mm crestal bone height to maxillary sinus floor; At least 6mm bone width; Insertion torque between 20-50 Ncm.
Exclusion criteria: Patients with any infectious or systemic diseases; smokers; history or presence of periodontitis; Fresh Socket Implantation; Need of supplemental surgery such as ridge splitting and ridge augmentation.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran. Isfahan Isfahan Iran, Islamic Republic Of
City
Isfahan
Postal code
00983116641410
Approval date
2012-04-28, 1391/02/09
Ethics committee reference number
91020909302
Health conditions studied
1
Description of health condition studied
Partial edentulous in posterior maxillary segments
ICD-10 code
k08.1
ICD-10 code description
Loss of teeth due to accident, extraction or local periodontal disease
Primary outcomes
1
Description
Numerical value of PTV
Timepoint
0, 1, 3 months after surgery and 3 months after loading
Method of measurement
By means of a Periotest device
2
Description
Radiographic crestal bone loss
Timepoint
0, 1, 3 months after surgery and 3 months after loading
Method of measurement
By use of parallel periapical radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Placement of Dentis HA coated implants.
Category
Treatment - Surgery
2
Description
Control: Placement of Dentis RBM implants.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad Dental School Khorasgan Branch, (Isfahan)
Full name of responsible person
Nasim Farkhani
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research of Islamic Azad Dental School Khorasgan Branch, (Isfahan)
Full name of responsible person
Payam Najafi
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street.
City
Isfahan
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 of Islamic Azad Dental School Khorasgan Branch, (Isfahan)
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
Islamic Azad Dental School Khorasgan Branch, (Isfahan)
Full name of responsible person
Nasim Farkhani
Position
Postgraduate student of periodontics
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street.
City
Isfahan
Postal code
Phone
+98 31 1260 1550
Fax
Email
nasimfarkhani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan)
Full name of responsible person
Nasim Farkhani
Position
Postgraduated Student of Periodontics
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street.
City
Isfahan
Postal code
Phone
+98 31 1260 1550
Fax
Email
nasimfarkhani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan)
Full name of responsible person
Nasim Farkhani
Position
Postgraduated Student of Periodontics
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street.
City
Isfahan
Postal code
Phone
+98 31 1260 1550
Fax
Email
nasimfarkhani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)