Rehabilitation of Posterior Atrophic Edentulous Mandibles with Prostheses Supported by 4 mm Long Implants or Longer Implants in Vertically Augmented Bone
The aim of this RCT is to compare the outcome of partial fixed prostheses supported by 4-mm long implants (4SI, Straumann AG, Basel, Switzerland) with prostheses supported by implants of at least 10-mm long placed in posterior atrophic edentulous mandibles augmented with Guided bone regeneration (GBR) technique.
Twenty four patients with bilateral atrophic mandibles having 5 to 7.9 mm bone height above the mandibular canal will be randomised according to a split-mouth design to receive two to four 4 mm long implants (4SI, Straumann AG, Basel, Switzerland) or at least 10-mm long implants (Straumann) in augmented bone. Mandibles will be vertically augmented with GBR, using combination of intraoral autogenous bone graft and allograft. Implants will be placed after 6 months. Patient will be followed for one year and outcome measures will be peri-implant marginal bone level changes, implant and prosthesis failures and any complication.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051122226N1
Registration date:2016-04-22, 1395/02/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-22, 1395/02/03
Registrant information
Name
Tahereh Bitaraf
Name of organization / entity
Dental Implant Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8351
Email address
taherehbitaraf@yahoo.com
Recruitment status
Recruitment complete
Funding source
Dental Research Institute of Tehran University of Medical Sciences
Expected recruitment start date
2016-04-01, 1395/01/13
Expected recruitment end date
2019-01-01, 1397/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Rehabilitation of Posterior Atrophic Edentulous Mandibles with Prostheses Supported by 4 mm Long Implants or Longer Implants in Vertically Augmented Bone
Public title
Evaluation of Two Types of Dental Implants in Lower Jaws
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Bilateral edentulism in posterior mandible with a similar degree of bone atrophy on both sides requiring two to four dental implants; Vertical bone heights have to be 5 mm to 7.9 mm above the mandibular canals.
Exclusion criteria: General contraindications to implant surgery subjected to irradiation in the head and neck area; immunosuppressed or immunocompromised; treated or under treatment with intravenous amino-bisphosphonates; untreated periodontitis; poor oral hygiene and motivation; uncontrolled diabetes; pregnant or nursing; substance abuse; psychiatric problems or unrealistic expectations; lack of opposite occluding dentition in the area; acute or chronic infection/inflammation in the area intended for implant placement; extraction sites with less than 3 months of healing.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tehran University of Medical Sciences
Street address
4th Floor, No. 23, before Pour Sina St, 16th Azad St., Keshavarz Blvd
City
Tehhran
Postal code
Approval date
2016-02-01, 1394/11/12
Ethics committee reference number
IR.TUMS.REC.1394.1798
Health conditions studied
1
Description of health condition studied
Mandible, Edentulous, Partially
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
Peri-implant marginal bone level changes
Timepoint
at implant placement (6 months after GBR), at delivery of the prostheses (2 months after implantation), 1 year after loading
Method of measurement
Intraoral radiographs
Secondary outcomes
1
Description
Implant and prosthesis failures
Timepoint
during 1 years follow-up
Method of measurement
Observational
Intervention groups
1
Description
Intervention group:4-mm long Straumann SLActive implant (4SI, Straumann AG, Basel, Switzerland) during 1- year follow-up
Category
Treatment - Devices
2
Description
Control group: 10 or 8 mm long Straumann implant in augmented bone (Straumann AG, Basel, Switzerland) during 1- year follow-up
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Implant Research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr Tahereh Bitaraf
Street address
First Floor, Dental Implant Research Center, Dental Research Institute, Ghods St, Enghelab Ave
City
Tehran
2
Recruitment center
Name of recruitment center
Faculty of Dentistry of Tehran University of Medical Sciences
Full name of responsible person
Dr Tahereh Bitaraf
Street address
North Karegar St, after Atomic Energy Organization, Faculty of Dentistry
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Research Institute of Tehran University of Medical Sciences
Full name of responsible person
Dr Shahroo Etemad-Moghadam
Street address
Third Floor, Dental Research Center, Dental Research Institute, Ghods St, Enghelab Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Research Institute of Tehran University of Medical Sciences
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
Dental Implant Research Center
Full name of responsible person
Dr Tahereh Bitaraf
Position
Student of PhD by Research
Other areas of specialty/work
Street address
First Floor, Dental Implant Research Center, Dental Research Institute, Ghods St, Enghelab Ave
City
Tehran
Postal code
Phone
+98 21 8897 8351
Fax
Email
t-bitaraf@razi.tums.ac.irtaherehbitaraf@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Implant Research Center of Tehran University of Medical Sciences
Full name of responsible person
Amirreza Rokn
Position
Professor
Other areas of specialty/work
Street address
First Floor, Dental Implant Research Center, Dental Research Institute, Ghods St, Enghelab Ave
City
Tehran
Postal code
Phone
+98 21 8897 8351
Fax
Email
roknamir@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Implant Research Center
Full name of responsible person
Dr Tahereh Bitaraf
Position
Student of PhD by Research
Other areas of specialty/work
Street address
First Floor, Dental Implant Research Center, Dental Research Institute, Ghods St, Enghelab Ave