Evaluation and comparison of marginal bone loss and patient satisfaction in one- implant retained mandibular overdenture and tow-implant retained mandibular overdenture with immediate functional loading
The purpose of this study was to evaluate and compare marginal bone loss and satisfaction of one and two implants retained mandibular overdentures with immediate loading in anterior mandible. A total of twenty edentolous patients whose chief complaints are poor retention and stability in mandibular denture, denture soreness and phonetic problems, will be recruited. The patients should have extracted tooth at least 12 months prior to the study and have good bone for insertion of implant with at least 10mm length and 4mm diameter. The patients will randomly be assigned into one of the two groups: 1) 10 patients will take one implant in position C (Misch). 2) 10 patients will take two implants in position B and D (Misch). Mandibular overdentures will be delivered with proper housing at last 48 hours after implant insertion. Digital radiographs will be made with custom film holders for marginal bone loss evaluation and Visual analogue scale questionnaires will be used to record patient satisfaction, immediately, and 1,3, and 6 months after the surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010265029N1
Registration date:2011-01-20, 1389/10/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-20, 1389/10/30
Registrant information
Name
Fariborz Vafaee
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1824 1961
Email address
fvafaee@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental school, Hamadan Medical Science University
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of marginal bone loss and patient satisfaction in one- implant retained mandibular overdenture and tow-implant retained mandibular overdenture with immediate functional loading
Public title
Comparison of one vs two implant overdentutres
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: using complete denture with looseness problem
Exclusion criteria: uncontrolled diabetes, heavy smoking
Age
From 25 years old to 80 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan Medical Science University Ethics Committee
Street address
Pajohesh cross, Hamadan
City
Hamdan
Postal code
Approval date
2010-09-13, 1389/06/22
Ethics committee reference number
پ/16/35/89445
Health conditions studied
1
Description of health condition studied
bone loss
ICD-10 code
M85.8
ICD-10 code description
Other specified disorders of bone density and structure
Primary outcomes
1
Description
cervical bone loss
Timepoint
Immediately and 1, 3, and 6 months after the intervention
Method of measurement
digital periapical radiography
Secondary outcomes
1
Description
Patient's satisfaction
Timepoint
Immediately and 1, 3, and 6 months after the intervention
Method of measurement
VAS
Intervention groups
1
Description
Control group: use of two implant in anterior mandible
Category
Rehabilitation
2
Description
Intervention group: use of one implant in anterior mandible
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Hamadan Medical Science University
Full name of responsible person
Dr Fariborz Vafaee
Street address
Dental school, Pajohesh Cross
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental School, Hamadan Medical Science University
Full name of responsible person
Dr Fariborz Vafaee
Street address
Dental school, Pajohesh square
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental School, Hamadan Medical Science University
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 Dental School, Hamadan Medical Science University
Full name of responsible person
Dr Fariborz Vafaee
Position
Assistant Professor
Other areas of specialty/work
Street address
Dental school, Pajohesh Cross
City
Hamadan
Postal code
Phone
+98 81 1824 1961
Fax
Email
fvafaee@umsha.ac.irfvafaee@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School, Hamadan Medical Science University
Full name of responsible person
Dr Fariborz Vafaee
Position
Assistant Professor
Other areas of specialty/work
Street address
Dental School, Hamadan Medical Science University
City
Hamdan
Postal code
Phone
+98 81 1824 1961
Fax
Email
fvafaee@umsha.ac.irfvafaee@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School, Hamadan Medical Science University
Full name of responsible person
Dr Fariborz Vafaee
Position
Assistant Professer
Other areas of specialty/work
Street address
Dental School, Hamadan Medical Science University
City
Hamedan
Postal code
Phone
+98 81 1824 1961
Fax
Email
fvafaee@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)