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Clinical evaluation of gingival condition around the implants in one implant retained mandibular overdentures and two implant retained mandibular overdentures with immediate loading in anterior mandible.

Protocol summary

Summary
Since the retention of mandibular dentures are less than maxillary dentures, use of conventional mandibular dentures is not satisfying. Introduction of dental implants improves quality of life of edentulous patients. Many patients could not pay much money to have two implants because they are expensive. Twenty patients with mandibular dentures whose dentures were not stable in the mouth and referred to prosthetic department of dentistry college of Hamedan medical university that were volunteer to receive implant were selected. All patients should be edentolous for at least twelve months and their dentures should not need relying. A stent duplicate from patients dentures and implant positions determined on the CBCT basis. Then patients divided into two groups randomly. Single implant group(interventional group): who receive one implant in C region of mandible Two implant group (control group): who receive two implant in B and D regions of mandible Then the soft tissue conditions around implants in both groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010265030N1
Registration date: 2011-03-02, 1389/12/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-03-02, 1389/12/11
Registrant information
Name
Parviz Torkzaban
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1251 1724
Email address
torkzaban@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research ,Hamedan University of Medical Sciences
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
Clinical evaluation of gingival condition around the implants in one implant retained mandibular overdentures and two implant retained mandibular overdentures with immediate loading in anterior mandible.
Public title
Evaluation of gingival condition around the implants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion :edentulous patients Exclusion: uncontrolled systemic disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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 commitee of Hamedan medical university
Street address
Hamedan medical university.Pazhouhesh high way. Hamedan.
City
Hamedan
Postal code
Approval date
2010-09-13, 1389/06/22
Ethics committee reference number
89465/9/35/16/پ

Health conditions studied

1

Description of health condition studied
Gingival recession
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge

Primary outcomes

1

Description
Probe depth of the gingiva
Timepoint
1,3,6 Monthes after surgery
Method of measurement
With periodontal probe

Secondary outcomes

empty

Intervention groups

1

Description
Reduce numbers of implants to one in interventional group ( single implant group)
Category
Treatment - Surgery

2

Description
control group: two implant group Intervention is reduce the number of implants to one.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Periodontics department, dental faculty, Hamedan University of Medical Sciences
Full name of responsible person
Dr Parviz Torkzaban
Street address
Periodontics department, Dental facultyof Hamedan medical university,Pazhouhesh highway, Hamedan
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Hamedan university of medical science
Full name of responsible person
Dr Ghaleeeha
Street address
Periodontics department, Dental faculty, Hamedan university of medical
City
Hamedan
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, Hamedan university of medical science
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
Hamedan University of Medical Science
Full name of responsible person
Dr Parviz Torkzaban
Position
Assistant professor
Other areas of specialty/work
Street address
Periodontics department , Dental faculty, Hamedan University of Medical Science
City
Hamedan
Postal code
Phone
+98 81 1251 1724
Fax
Email
Torkzaban@umsha.ac.ir; Fvafaee@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Dr Parviz Torkzaban
Position
Assistant professor
Other areas of specialty/work
Street address
Periodontics department, Dental faculty, Hamedan university of medical science
City
Hamedan
Postal code
Phone
+98 81 1251 1724
Fax
Email
Torkzaban@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University Medical Science
Full name of responsible person
Dr Parviz Torkzaban
Position
Assistant professor
Other areas of specialty/work
Street address
Periodontics department, Dental faculty, Hamedan university of medial science
City
Hamedan
Postal code
Phone
+98 81 1251 1724
Fax
Email
Torkzaban@umsha.ac.ir
Web page address

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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