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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
Sponsor:
Information provided by (Responsible Party):
Enilson Antonio Sallum, University of Campinas, Brazil

Brief Summary:
The objective of this randomized and longitudinal clinical study is to compare the installation of immediate implants in the esthetic zone through computer-guided-surgery and conventional surgery. To this end, 22 patients who need implant-supported replacement on the anterior region of the maxilla will be selected and after extraction will receive: Guided surgery (GS): installation of dental implant with the aid of the virtually planned guide by means of specific software; Conventional surgery (CS): installation of dental implant performed freehand using a conventional surgical guide made by study models.

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

Detailed Description:
The objective of this randomized and longitudinal clinical study is to compare the installation of immediate implants in the esthetic zone through computer-guided-surgery and conventional surgery. To this end, 22 patients who need implant-supported replacement on the anterior region of the maxilla will be selected and after extraction will receive: Guided surgery (GS): installation of dental implant with the aid of the virtually planned guide by means of specific software; Conventional surgery (CS): installation of dental implant performed freehand using a conventional surgical guide made by study models. Tomographies will be performed 10 days after the surgery for the measurement of both linear and angular shifts between the installed implants and the virtual planning. All the clinical and radiographic assessments (Plaque and Bleeding Index, Drilling Depth, Relative Clinical Insertion Level and the Margin Position of Peri-Implant Mucosa) will be carried out after the surgery and within 6 and 12 months of post-operative. Assesments of the esthetic success (pink/white score) and survival and success of the implant will also be carried out. In the prosthetic part, it will be assessed the abutment mobility; corrective measures for the prothesis; repair on prothesis or abutment. The success and survival assessments of crowns will be done through structure fracture, occlusal roughness, marginal integrity and contour of the restoration. It will also be assessed the procedural impact in quality of life by applying a 36-closed-question-survey focused on appearence, pain, oral comfort, general performance, feeding and chewing. Subsequently, the data will be tabulated, and according to their distribution, the appropriate statistical tests will be applied, considering a 5% index of significance to all the analyses.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Relative gingival margin position [ Time Frame: Immediately after surgery, 6 months, 12 months ]
    Distance from stent probing to peri-implant margin tissue

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with sufficient bone volume availability apically and palatally that allows the correct positioning of the implants (Kan et al, 2011);
  • Implants with primary stability of 20-45 N (Gallucci et al, 2014);
  • Patients with teeth to be extracted in the Class I, II or III corono-radicular position, according to Kan et al. (2011);
  • Patients with distance from the bone crest to the point of contact in adjacent teeth less than or equal to 6.5mm (Buser et al 2017).

Exclusion Criteria:

  • Presence of diabetes, blood disorders and systemic diseases that prevent the surgical procedure;
  • History of radiotherapy in the head or neck region;
  • History of treatment with bisphosphonates;
  • Pregnant or lactating women;
  • Patients with teeth to be extracted in the Class V corono-radicular position, according to Kan et al. (2011);
  • Gingival recession in the teeth indicated for exodontia (Kan et al, 2001);
  • Acute infection at the implant site (Morton et al, 2014);
  • Unavailability to attend the FOP / UNICAMP on the pre-determined days.

Information from the National Library of Medicine

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


Contacts
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Contact: Enilson A Sallum, PhD +55 19 2106-5301 esallum@unicamp.br

Locations
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Brazil
Piracicaba Dental School, State University of Campinas Recruiting
Piracicaba, São Paulo, Brazil, 13414-903
Contact: Enilson Sallum, PhD    +55 19 2106 5200    enilson@unicamp.br   
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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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

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Responsible Party: Enilson Antonio Sallum, Full professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT03986164     History of Changes
Other Study ID Numbers: 09409619.3.0000.5418
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Enilson Antonio Sallum, University of Campinas, Brazil:
Guided Surgery
Linear Shifts
Angular Shifts
Satisfaction