1- Purpose: the patient satisfaction and treatment success rate of immediate loaded one and two implant retained mandibular overdenture was measured by Visual Analog Scale (VAS) before implant placement and six months and one year after implant placement.
2- Design assignation: Cllinical randomized trial study,case group including edentulous patient with complete dentures experience received mandibular implant retained immediate loaded single implant and controlled groups including edentulous patient with complete dentures experience received mandibular implant retained immediate loaded bilateral implant
3- Material and methods:20 edentulous patient, ten in case goups and ten in controlled groups who are dissatisfy with their complete dentures retention and function enroll in this study. Each participant completed a baseline questionannaire on retention, masticatory function and general satisfaction which measured with Visual Analog Scale(VAS).Surgical and prosthodontic procedures appleid according to standard ptotocol in two groups. In case groups midline implant and in control groups bilateral implants immediately loaded. Primary and secondary outcome s including satisfactions, implant and mandibular overdenture denture survival measured after six and twelve months.
4- Participants: Participants in both groups twenty edentulous patients with at least six months experience with conventional complete dentures, were selected from respondents to a university dental clinic's reqest for volunteers. Candidate screend to verify suffiecent bone in anterior of mandible and stable medical conditions.
5-Interventions: 1- Implant surgery and placement of three dental implant in anterior mandible, connection of locator abutments and immediatly loading of two groups according to the mentioned protocol.
6- Outcomes: Primary outcomes including measuement of participants satisfaction regarding retention of overdentures, function and general satisfaction .Secondary outcomes including implant and prosthodontics survival.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112198464N1
Registration date:2012-07-05, 1391/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-05, 1391/04/15
Registrant information
Name
Parsa Atashrazm
Name of organization / entity
Islamic Azad Dental School
Country
Iran (Islamic Republic of)
Phone
+98 21225645713
Email address
p_atashrazm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University and Doursanteb Company
Expected recruitment start date
2011-07-17, 1390/04/26
Expected recruitment end date
2012-07-15, 1391/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of patient satisfaction and treatment success rate of immediate loaded one and two implant-retained mandibular overdenture
Public title
Patient satisfaction and treatment success rate of implant-retained mandibular overdenture
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria:
1- diabetics.
2- heavy smokers.
3- sever systemic problem.
Inclusion criteria:
1- minimum of 10 mm bone height in anterior mandible.
2- Edentulous patients.
3- accepatable complete dentures.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
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
Islamic Azad University, Dental Branch, Ethics Committe
Street address
Islamic Azad Dental School ,10th neystan, Pasdaran
City
Tehran
Postal code
1946853314
Approval date
2011-05-20, 1390/02/30
Ethics committee reference number
د/229/پ
Health conditions studied
1
Description of health condition studied
Fully edentulous patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient's satisfaction
Timepoint
Before implant insertion, six and tweleve months after implant loading
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Implant survival
Timepoint
From starting piont of treatment to one year
Method of measurement
Observation
2
Description
Overdenture Survival
Timepoint
Six and Twelve months after immeadiate Loading
Method of measurement
Observation
Intervention groups
1
Description
Placement of single implant with immediate loading in intervetion group2-placement of two implants with immediate loading in control group
Category
Treatment - Surgery
2
Description
Off-loading of immediate loaded single implant and delayed loading of bilateral implants in case groups 2- off-loading of immediate loaded bilateral implants and delayed loading of single implants in control groups
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Removable prosthodontics department of Islamic Azad university
Full name of responsible person
Dr. Atashrazm
Street address
10 Neystan, Pasdaran, Islamic Azad University, Dental branch
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic azad University
Full name of responsible person
Dr. Harajie
Street address
10 neyestan, Pasdaran, Islamic azad University, Dental Branch
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic azad University
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Dorsunteb
Full name of responsible person
Mr. Safari
Street address
Unit. 3, First floor,No. 724, Sattar Khan Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dorsunteb
Proportion provided by this source
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 University, Dental Branch
Full name of responsible person
Parsa Aashrazm
Position
Chair of removable prosthodontics department/ Associate professor
Other areas of specialty/work
Street address
10th neyestan, Pasdaran,Islamic Azad University, Dental Branch
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
+98 21 2256 4577
Email
p_atashrazm@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic azad University, Dental Branch
Full name of responsible person
Parsa Atashrazm
Position
Assocaite Professor
Other areas of specialty/work
Street address
10th Neyestan, Pasdaran,Islamic azad University, dental branch
City
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
Email
p_atashrazm@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Dental Branch
Full name of responsible person
Leilla Zamani Alavijeh
Position
Post graduate student
Other areas of specialty/work
Street address
10th neyestan, Pasdaranislamic Azad University, Dental Branch
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
drl.zamani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)