Implants Immediately Installed in Esthetic Area With Computer-guided Surgery

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Implants
• Intervention / Treatment: Device: Guided surgery with bovine spongious bone substitute; Device: Conventional surgery with bovine spongious bone substitute

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.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Piracicaba, São Paulo, Brazil, 13414-903
      • Piracicaba Dental School, State University of Campinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Estimated): December 20, 2023
• Study Completion (Estimated): December 20, 2023

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Satisfaction; Guided Surgery; Linear Shifts; Angular Shifts
• Other Study ID Numbers: 09409619.3.0000.5418

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No