Assessment in humans of aesthetics and functions of common implants restored with crowns and porcelain metal crowns and porcelain only

• Register: REBEC
• Last refreshed on: 27 May 2013
• Main ID: RBR-4hmrph
• Date of registration: 31/01/2012
• Primary sponsor: Universidade Federal de Juiz de Fora - Juiz de Fora, MG, Brazil
• Public title: Assessment in humans of aesthetics and functions of common implants restored with crowns and porcelain metal crowns and porcelain only
• Scientific title: Comparative analysis of aesthetic and functional parameters of implant abutments using ceramic and metallic
• Date of first enrolment: 01/08/2011
• Target sample size: 35
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-4hmrph/
• Study type: Intervention
• Study design: Therapeutic, parallel, two arms, double-blind, randomized controlled, prospective clinical trial

Countries of recruitment

Brazil

Contacts

• Name: Thais Bittencourt
• Affiliation: Universidade Federal de Juiz de Fora

• Name: Thais Bittencourt
• Affiliation: Universidade Federal de Juiz de Fora

Key inclusion & exclusion criteria

Inclusion criteria: of both genders,
without regard to race,
aged 18 years and
need for rehabilitation with crowns and bridges up to two elements of the implant in the anterior region, totaling sixty sites for implants .
Exclusion criteria: smoking,
with systemic diseases,
need for bone grafting and
parafunctional habits.

Age minimum: 18Y
Age maximum: 65Y
Gender: -

Health Condition(s) or Problem(s) studied

Dental implant, dental implant fixed, arcade, Edentulous, Partially, cosmetic dentistry
E04.545.550.280
E06.420
E06.780.345.630
C05.500.480.450

Intervention(s)

1) Surgical procedures: For the 35 individuals selected, the placement of surgical implants (Porous Master line, hexagonal - Connection Implant Systems, Arujá / SP, Brazil) will be conducted in accordance with the standards of biosecurity and receive drug therapy pre and post-operative and post-surgical guidelines. The guide will assist in surgical placement of implants, previously defined. The time required for osseointegration is awaited, three months to five months for the mandible and the maxilla. 2) Radiographic Procedures: There will be four digital periapical radiographs of each patient: 1) immediately after implant placement, 2) after the osseointegration period (three months to five months for the mandible and maxilla), 3) three months after installation prosthesis and 4) five months after installation of the prosthesis; Of the sixty initial radiographs (T1) and sixty taken after a period of osseointegration (T2) will be chosen 14 of each group, which will feature a range of 10 to 20 degrees of vertical angle and 10 º horizontal, to be applied the technique of digital subtraction radiography (SRD group). All digital radiographs will be subject to verification of loss or gain bone around the implant, using subjective visual analysis. 3) Prosthetic procedures: After radiography, the surgeries will be performed for the reopening of the implants. Completed the period of soft tissue healing, the crowns will be made and / or fixed prostheses. Patients will be divided into two groups: GAT - Group Ti abutments prefabricated implants in 30 / 1; GAZ - group zirconia abutments prefabricated implants in the thirty remaining. The abutments will be to varying external hexagon only possible angle and diameter of the platform used. Crowns and / or fixed prosthesis group on coping GAT will be made of metal (Precision System Connection ®) with application of ceramic, the GAZ Group, the prefabricated abutment in zirconia is prepared manually. Thus, the abutments of both group

Primary Outcome(s)

Identify an aesthetic best rehabilitated with implants in the pillars and crowns with zirconia copings made by CAD CAM system, in relation to conventional metal-ceramic crowns.
The evaluations will follow the parameters:
Evaluation of clinical criteria for success "1" - the absence of persistent subjective complaints such as pain, foreign body sensation, and / or paresthesia, "2" - the absence of recurring peri-implant infection with suppuration and, "3" - lack of mobility.

Evaluation of the index card as a visual scale, where "0" - no plaque deposits, "1" - sliding plate visible only after the probe on the free surface of the marginal gingiva of the implant, "2" - plate clinically visible and , "3" - plate abundant.

Evaluation of the sulcus bleeding index scores using "0" - no bleeding when the tip of the periodontal probe is passed along the gingival margin to the implant, "1" - isolated bleeding points visible, "2" - bleeding forms a confluent red line on the shore and, "3" - profuse bleeding.

Aesthetic evaluation of the index according to the following criteria: relevance, inclusion of peri-implant soft tissues relevant specific parameters inherent in the restoration, establishment of clinical acceptability, ease of use and reproducibility. For aesthetic content will be used the following scores: PES, which evaluates the gum tissue around the implant and WES, which will assess part of the prosthetic crown that emerges from the peri-implant tissues. For the PES will be used the following scores: "1" - corresponds to mesial papilla, "2" - corresponds to the distal papilla; "3" - curvature of the cervical buccal mucosa, "4" - level / height of the vestibular and cervical mucosa; "5" - root convexity, color and texture of the tissue over the implant. For the WES scores will be used for aesthetic parameters of the crowns: "1" - corresponds to the shape of the tooth, "2" - corresponds to the volume, "3" - color "4" - the texture of the facial and cervical face, "5 "- translucency and characterization of the five parameters described coroa.Os aciam for both PES and to WES, under optimal conditions, will result in a score of 10, the threshold of clinical acceptability is set to" 6 ".
For evaluation of peri-implant tissues will be used a millimeter Hu-Friedy probe to measure the depth of the peri-implant tissues as follows: DIM - distance from the shoulder (platform) of the implant to the gingival margin; PPD - drilling depth of peri-implant and, PAL - level of peri-implant insertion, which corresponds to the sum of DIM + PPD.

Expected results for each parameter used: clinical success (scores 1, 2 and 3), index card (score 0), the sulcus bleeding index (score 0), PES and WES aesthetic index (scores equal to or greater from the point of acceptability of 6), peri-implant tissues measured with millimetric probe Hu-Friedy have a PAL ranging from 4 to 7 mm.

Secondary Outcome(s)

Bone gain around implants assessed by radiographic analysis based on the Likert scale with the aid of digital subtraction radiography.
Expected to be observed that the initial radiograph (T1) in relation to the second radiograph (T2) show a clear picture that there was bone formation around the implant platform (site mesial and distal site), and the overall image quality excellent for purposes of evaluating change or gained bone around the implant platform, and that the appraiser would have confidence in making opinion about gain or bone loss around the implant platform based on this image (Likert Scale).

Secondary ID(s)

156/2010

Source(s) of Monetary Support

Conexão Sistemas de Prótese - Arujá, SP, Brazil

Secondary Sponsor(s)

Universidade Federal de Juiz de Fora - Juiz de Fora, MG, Brazil