Evaluation of two types of implants installed in the jaw

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-6c2k3m
• Date of registration: 16/04/2012
• Primary sponsor: Universidade de São Paulo - São Paulo, PR, Brazil
• Public title: Evaluation of two types of implants installed in the jaw
• Scientific title: A comparative study of marginal bone variation around Titanium-13Zirconium and versus Titanium Grade IV.
• Date of first enrolment: 02/05/2011
• Target sample size: 12
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-6c2k3m/
• Study design: Therapeutic, parallel, with two arms, double-blinded, randomized-controlled clinical trial

Countries of recruitment

Brazil

Contacts

• Name: Lívia Tolentino
• Affiliation: Universidade de São Paulo

• Name: Lívia Tolentino
• Affiliation: Universidade de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: To sign voluntary informed consent for using his/her data;
At least 18 years-old;
Posterior edentulous areas that needed at least 2 implants in the maxilla, or 2 implants in the mandible
To have a posterior area to receive one narrow implant diameter at least 8 weeks to implant installation;
5 mm of ridge width and 8 mm of lengh; These implants had to receive one single-crown rehabilitation and to have a antagonist tooth
1 year of follow up.
Exclusion criteria: Presence of sistemic problems, ex. diabetes
Use of any drug that could affect bone metabolism (biphosphonates);
Tobacco abuse (> 10 cigarettes/day);
Presence of immunocompromising conditions (HIV-positive, AIDS, or under therapy with immunosuppressive drugs);
Disability that interferes with the ability of a suitable cleaning;
History of radiotherapy of the head/neck region .
Pregnancy or lactating;
Condition or circumstance that may lead patients to abandon the study;
Presence of untreated periodontitis;
Soft and/or hard tissues alterations;
Previous bone augmentation procedure in the same place to fixture installation;
Presence of parafunctional habits;


Age minimum: 18Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

Patients with partially edentulous jaw that need to be restored with single crowns
C05.500.480.450

Intervention(s)

12 SLActive® Implants (Control Group) and 12 Roxolid® Implants (Test Group)(Straumann® Dental Implant System, Basel, Switzerland), both with 3.3 diameter and platform 4.8 mm were installed in the posterior region of the jaw in 12 healthy patients. The patients received, randomly, in contralateral regions, one implant of each diameter in the mandible. Neither the patient nor the clinical know what type of implant was installed in each region. The patients received the implants, 6 weeks after received the protheses and periapical radiographs and computed tomography scans were performed 1 year after the prostheses were in function.

Primary Outcome(s)

Comparison of the bone level between TiZr and Ti after 1 year of clinical, radiogrphically and tomographically follow up.It is expected that after the follow up the Titanium-Zirconium implants provide a higher success rate

Secondary Outcome(s)

Reduced in the failure of the prosthesis in Titanium Zirconium implants after 1 year of follow up through the clinical analysis of fractures in prosthetic components and / or remission of the screws.

Secondary ID(s)

0025.0.107.000-11

Source(s) of Monetary Support

Universidade de São Paulo - São Paulo, PR, Brazil

Secondary Sponsor(s)

Universidade de São Paulo - São Paulo, PR, Brazil