Implants Immediately Installed in Esthetic Area With Computer-guided Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implants Immediately Installed in Esthetic Area With Computer-guided Surgery: Randomized Clinical Trial

Conditions
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Dental Implants

Intervention / Treatment
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* Device: Guided surgery with bovine spongious bone substitute
* Device: Conventional surgery with bovine spongious bone substitute


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Guided surgery (GS)<br>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<br>* 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.<br>|
| Active Comparator: Conventional surgery (CS)<br>Installation of dental implant performed freehand using a conventional surgical guide made by study models | Device: Conventional surgery with bovine spongious bone substitute<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Position of the implant | Difference between angular position of the implant by computer software and angular position of the implant by free hand. | Baseline, 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative gingival margin position | Distance from stent probing to peri-implant margin tissue | Immediately after surgery, 6 months, 12 months | 
| Peri-implant probing depth | Distance from peri-implant mucosa to more apical portion of peri-implant sulcus | Immediately after surgery, 6 months, 12 months | 
| Relative clinical attachment level | Distance from stent probing to more apical portion of peri-implant sulcus | Immediately after surgery, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guided Surgery, Linear Shifts, Angular Shifts, Satisfaction