Dental Implants Clinical Trial
Official title:
Implants Immediately Installed in Esthetic Area With Computer-guided Surgery: Randomized Clinical Trial
Verified date | August 2023 |
Source | University of Campinas, Brazil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 22 |
Est. completion date | December 20, 2023 |
Est. primary completion date | December 20, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Piracicaba Dental School, State University of Campinas | Piracicaba | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Relative gingival margin position | Distance from stent probing to peri-implant margin tissue | Immediately after surgery, 6 months, 12 months | |
Secondary | Peri-implant probing depth | Distance from peri-implant mucosa to more apical portion of peri-implant sulcus | Immediately after surgery, 6 months, 12 months | |
Secondary | Relative clinical attachment level | Distance from stent probing to more apical portion of peri-implant sulcus | Immediately after surgery, 6 months, 12 months |
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