Implants Immediately Installed in Esthetic Area With Computer-guided Surgery

University of Campinas, Brazil

Status: Completed

Conditions: Dental Implants

Treatments: Device: Guided surgery with bovine spongious bone substitute; Device: Conventional surgery with bovine spongious bone substitute

Study type: Interventional

Funder types: Other

Identifiers

NCT03986164

09409619.3.0000.5418

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Guided surgery (GS)

Active Comparator group

Description:

Installation of dental implant with the aid of the virtually planned guide by means of specific software

Treatment:

Device: Guided surgery with bovine spongious bone substitute

Conventional surgery (CS)

Active Comparator group

Description:

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

Treatment:

Device: Conventional surgery with bovine spongious bone substitute