Clinical trial NCT03986164: Implants Immediately Installed in Esthetic Area With Computer-guided Surgery
Official title: Implants Immediately Installed in Esthetic Area With Computer-guided Surgery: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Keywords: Guided Surgery
Linear Shifts
Angular Shifts
Satisfaction
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Position of the implant
timeFrame: Baseline, 10 days
Secondary outcomes:
measure: Relative gingival margin position
timeFrame: Immediately after surgery, 6 months, 12 months
measure: Peri-implant probing depth
timeFrame: Immediately after surgery, 6 months, 12 months
measure: Relative clinical attachment level
timeFrame: Immediately after surgery, 6 months, 12 months
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School, State University of Campinas
state: São Paulo
Study officials:
affiliation: Piracicaba Dental School, State University of Campinas
name: Enilson A Sallum, PhD
role: STUDY_CHAIR
affiliation: Piracicaba Dental School, State University of Campinas
name: Felipe T Galvão, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Piracicaba Dental School, State University of Campinas
name: Thayane C Businari, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Piracicaba Dental School, State University of Campinas
name: Raíssa Micaella M Machado, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piracicaba Dental School, State University of Campinas
name: Altair Antoninha D Cury, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piracicaba Dental School, State University of Campinas
name: Márcio Z Casati, PhD
role: PRINCIPAL_INVESTIGATOR
References: