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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02405169




Registration number
NCT02405169
Ethics application status
Date submitted
16/03/2015
Date registered
1/04/2015
Date last updated
1/10/2024

Titles & IDs
Public title
4 vs 6 Implants in Totally Edentulous Patient in Maxilla With Ti. Cad-cam Framework
Scientific title
Four Versus Six Endosseous Implants to be Used in the Rehabilitation of Totally Edentulous Patient in the Maxilla With Titanium Milled Framework
Secondary ID [1] 0 0
IIS-D-2012-031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Edentulous Maxilla 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Test -4 implants- - Evaluate marginal bone level (MBL) changes at implants that are placed in total edentulous patient when they are treated with four with titanium Cad/Cam framework.

Active comparator: Control -6 implants- - Evaluate marginal bone level (MBL) changes at implants that are placed in total edentulous patient when they are treated with six with titanium Cad/Cam framework
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Marginal bone resorption in millimeter from the the implant to the bone crest.
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Marginal bone resorption in millimeter from the the implant to the bone crest.
Timepoint [2] 0 0
3 year
Primary outcome [3] 0 0
Marginal bone resorption in millimeter from the the implant to the bone crest.
Timepoint [3] 0 0
5 year
Secondary outcome [1] 0 0
Fracture of the prosthetic components
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Fracture of the prosthetic components
Timepoint [2] 0 0
3 year
Secondary outcome [3] 0 0
Fracture of the prosthetic components
Timepoint [3] 0 0
5 year

Eligibility
Key inclusion criteria
Inclusion criteria:

1. age > 18 years;
2. edentulous maxilla or having hopeless remaining teeth that are intended to be extracted;
3. willingness to comply with all study requirements and to sign the IC;
4. have sufficient amount of bone (8mm or more) in the recipient site to allow implant placement without bone augmentation procedures.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. bone defects associated with severe knife-edge ridges;
2. bone defects resulting from tumor resection;
3. tobacco abuse (> 10 cigarettes/day);
4. severe kidney and liver disease;
5. history of radiotherapy in the head and neck region;
6. chemotherapy for treatment of malignant tumors at the time of the surgical procedure;
7. uncontrolled diabetes;
8. active periodontal disease involving the residual opposite dentition;
9. mucosal disease, such as lichen planus, in the areas to be treated;
10. poor oral hygiene;
11. non-compliant patients;
12. situations judged inconvenient(by the investigator) for the surgical treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2024
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Padova

Funding & Sponsors
Primary sponsor type
Other
Name
Institute Franci
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Denis Cecchinato, DDS
Address 0 0
Franci Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02405169