Implants Immediately Installed in Esthetic Area With Computer-guided Surgery

NCT03986164 | Completed DMC

• 1 other identifier: 09409619.3.0000.5418
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implants

Keywords

Guided Surgery; Linear Shifts; Angular Shifts; Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Relative gingival margin position

  Immediately after surgery, 6 months, 12 months

• Peri-implant probing depth

  Immediately after surgery, 6 months, 12 months

• Relative clinical attachment level

  Immediately after surgery, 6 months, 12 months

Study Arms (2)

Guided surgery (GS)

ACTIVE COMPARATOR

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

Conventional surgery (CS)

ACTIVE COMPARATOR

Installation of dental implant performed freehand using a conventional surgical guide made by study models

Device: Conventional surgery with bovine spongious bone substitute

Interventions

Guided surgery with bovine spongious bone substitute DEVICE

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.

Guided surgery (GS)

Conventional surgery with bovine spongious bone substitute DEVICE

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.

Conventional surgery (CS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Enilson A Sallum, PhD

  Piracicaba Dental School, State University of Campinas

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: April 10, 2019
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)