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出境医 / 临床实验 / Implants Immediately Installed in Esthetic Area With Computer-guided Surgery

Implants Immediately Installed in Esthetic Area With Computer-guided Surgery

Study Description
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.

Condition or disease Intervention/treatment Phase
Dental Implants Device: Guided surgery with bovine spongious bone substitute Device: Conventional surgery with bovine spongious bone substitute Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Implants Immediately Installed in Esthetic Area With Computer-guided Surgery: Randomized Clinical Trial
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : June 10, 2022
Estimated Study Completion Date : July 10, 2022
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. Position of the implant [ Time Frame: Baseline, 10 days ]
    Difference between angular position of the implant by computer software and angular position of the implant by free hand.


Secondary Outcome Measures :
  1. Relative gingival margin position [ Time Frame: Immediately after surgery, 6 months, 12 months ]
    Distance from stent probing to peri-implant margin tissue

  2. Peri-implant probing depth [ Time Frame: Immediately after surgery, 6 months, 12 months ]
    Distance from peri-implant mucosa to more apical portion of peri-implant sulcus

  3. Relative clinical attachment level [ Time Frame: Immediately after surgery, 6 months, 12 months ]
    Distance from stent probing to more apical portion of peri-implant sulcus


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Enilson A Sallum, PhD +55 19 2106-5301 esallum@unicamp.br

Locations
Layout table for location information
Brazil
Piracicaba Dental School, State University of Campinas Recruiting
Piracicaba, São Paulo, Brazil, 13414-903
Contact: Enilson Sallum, PhD    +55 19 2106 5200    enilson@unicamp.br   
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Layout table for investigator information
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
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date November 6, 2020
Actual Study Start Date  ICMJE April 10, 2019
Estimated Primary Completion Date June 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019) 		Position of the implant [ Time Frame: Baseline, 10 days ]
Difference between angular position of the implant by computer software and angular position of the implant by free hand.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Relative gingival margin position [ Time Frame: Immediately after surgery, 6 months, 12 months ]
    Distance from stent probing to peri-implant margin tissue
  • Peri-implant probing depth [ Time Frame: Immediately after surgery, 6 months, 12 months ]
    Distance from peri-implant mucosa to more apical portion of peri-implant sulcus
  • Relative clinical attachment level [ Time Frame: Immediately after surgery, 6 months, 12 months ]
    Distance from stent probing to more apical portion of peri-implant sulcus
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implants Immediately Installed in Esthetic Area With Computer-guided Surgery
Official Title  ICMJE Implants Immediately Installed in Esthetic Area With Computer-guided Surgery: Randomized Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Dental Implants
Intervention  ICMJE
  • 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.

  • 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.
Study Arms  ICMJE
  • Active Comparator: Guided surgery (GS)
    Installation of dental implant with the aid of the virtually planned guide by means of specific software
    Intervention: Device: Guided surgery with bovine spongious bone substitute
  • Active Comparator: Conventional surgery (CS)
    Installation of dental implant performed freehand using a conventional surgical guide made by study models
    Intervention: Device: Conventional surgery with bovine spongious bone substitute
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2019) 		22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 10, 2022
Estimated Primary Completion Date June 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Enilson A Sallum, PhD +55 19 2106-5301 esallum@unicamp.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986164
Other Study ID Numbers  ICMJE 09409619.3.0000.5418
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Enilson Antonio Sallum, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Campinas, Brazil
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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