Implants Immediately Installed in Esthetic Area With Computer-guided Surgery
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|ClinicalTrials.gov Identifier: NCT03986164|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dental Implants||Device: Guided surgery with bovine spongious bone substitute Device: Conventional surgery with bovine spongious bone substitute||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a longitudinal parallel randomized clinical trial, in Piracicaba Dental School, State University of Campinas (FOP-UNICAMP), periodic follow-ups will be performed for one year after the installation of implants in the anterior maxilla, by means of computer-assisted dental implant surgery or conventional surgery. The study will be conducted according to the Helsinki Declaration (2008), following the protocol for randomized clinical trials (Consort) (Schulz et al., 2010). The implant placement evaluations; radiographic and clinical evaluations of peri-implant tissues; as well as the success of the implants and the rehabilitation will be carried out immediately, 6 and 12 months after the implant installation.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Participating individuals will be allocated within each group through a computer-generated list, stored in a brown opaque envelope, under the care of an individual (TCB) other than the examiner. Only the professional responsible for the treatments will have access to the codes and both the patients and the examiners will be blind to the group to which each patient belongs, making possible the characterization of the study as double-blind.|
|Official Title:||Implants Immediately Installed in Esthetic Area With Computer-guided Surgery: Randomized Clinical Trial|
|Actual Study Start Date :||April 10, 2019|
|Estimated Primary Completion Date :||June 10, 2020|
|Estimated Study Completion Date :||July 10, 2020|
Active Comparator: Guided surgery (GS)
Installation of dental implant with the aid of the virtually planned guide by means of specific software
Device: Guided surgery with bovine spongious bone substitute
A minimally traumatic extraction will be performed aiming at the preservation of tissue integrity. After this step, milling will be performed using a sequence of guides and cutters recommended by the Raptor Implacil / Bioparts (Implacil De Bortoli) system manufacturer for implant installation (Cone Morse 3.5mm from 11-13mm Implacil De Bortoli) in computer-guided surgeries.
In the spaces between the implant and the buccal bone plate will be filled with xenogene biomaterial (Geistlich Bio-Oss 0.25-1mm). Immediately after implant installation, the prosthetic component (Smart Line, Trunnion CM 3.5mm - T 1.5-3.5mm, height 4mm - Implacil De Bortoli) will be placed.
If necessary, the sutures of the surgical procedures will be performed with polygalactin 5.0 (Vycril Rapid®, Jonhson's Jonhson, São José dos Campos) and will be removed after 7 days.
Active Comparator: Conventional surgery (CS)
Installation of dental implant performed freehand using a conventional surgical guide made by study models
Device: Conventional surgery with bovine spongious bone substitute
The sequence of cutters recommended by the manufacturer for this type of surgery and installation of the same type of implant (Cone Morse due cone 3.5mm) will be adopted. The perforations of the collar for future insertion of the implants will be performed aiming the installation of the implants with its platform installed with sub-crestal position. The implant should be installed along the palatine wall to obtain primary stability, at the center of the mesio-distal width predetermined by the final restoration, with a minimum distance of 2 mm from the adjacent tooth, and 3 mm from the free gingival margin, becoming slightly palatinate (Kan et al, 2018). Immediately after installation, the prosthetic component (Smart Line, Trunnion CM 3.5mm - T 1.5-3.5mm, height 4mm) will be placed. If necessary, the sutures of the surgical procedures will be performed with polygalactin 5.0 (Vycril Rapid®, Jonhson's Jonhson, São José dos Campos) and will be removed after 7 days.
- Position of the implant [ Time Frame: Baseline, 10 days ]Difference between angular position of the implant by computer software and angular position of the implant by free hand.
- Relative gingival margin position [ Time Frame: Immediately after surgery, 6 months, 12 months ]Distance from stent probing to peri-implant margin tissue
- Peri-implant probing depth [ Time Frame: Immediately after surgery, 6 months, 12 months ]Distance from peri-implant mucosa to more apical portion of peri-implant sulcus
- Relative clinical attachment level [ Time Frame: Immediately after surgery, 6 months, 12 months ]Distance from stent probing to more apical portion of peri-implant sulcus
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986164
|Contact: Enilson A Sallum, PhD||+55 19 email@example.com|
|Piracicaba Dental School, State University of Campinas||Recruiting|
|Piracicaba, São Paulo, Brazil, 13414-903|
|Contact: Enilson Sallum, PhD +55 19 2106 5200 firstname.lastname@example.org|
|Study Chair:||Enilson A Sallum, PhD||Piracicaba Dental School, State University of Campinas|
|Principal Investigator:||Felipe T Galvão, PhD Student||Piracicaba Dental School, State University of Campinas|
|Principal Investigator:||Thayane C Businari, PhD Student||Piracicaba Dental School, State University of Campinas|
|Principal Investigator:||Raíssa Micaella M Machado, PhD||Piracicaba Dental School, State University of Campinas|
|Principal Investigator:||Altair Antoninha D Cury, PhD||Piracicaba Dental School, State University of Campinas|
|Principal Investigator:||Márcio Z Casati, PhD||Piracicaba Dental School, State University of Campinas|