Dental ImplantsNCT03986164
Implants Immediately Installed in Esthetic Area With Computer-guided Surgery
A study testing Guided surgery with bovine spongious bone substitute and Conventional surgery with bovine spongious bone substitute in people with Dental Implants, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Guided surgery with bovine spongious bone substitute and Conventional surgery with bovine spongious bone substitute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Apr 2019to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, 13414-903
About this study
Official title: Implants Immediately Installed in Esthetic Area With Computer-guided Surgery: Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Dental Implants
- Being tested
- Guided surgery with bovine spongious bone substitute, Conventional surgery with bovine spongious bone substitute
- Keywords
- Guided Surgery, Linear Shifts, Angular Shifts, Satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided surgery with bovine spongious bone substituteDevice
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.
Conventional surgery with bovine spongious bone substituteDevice
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 group | Role | What they receive |
|---|---|---|
| Guided surgery (GS) | Active comparator | Installation of dental implant with the aid of the virtually planned guide by means of specific software Receives: 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 Receives: Device: Conventional surgery with bovine spongious bone substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Position of the implant
Difference between angular position of the implant by computer software and angular position of the implant by free hand.
Measured: Baseline, 10 days
Secondary outcomes (3)
Relative gingival margin position
Distance from stent probing to peri-implant margin tissue
Measured: Immediately after surgery, 6 months, 12 months
Peri-implant probing depth
Distance from peri-implant mucosa to more apical portion of peri-implant sulcus
Measured: Immediately after surgery, 6 months, 12 months
Relative clinical attachment level
Distance from stent probing to more apical portion of peri-implant sulcus
Measured: Immediately after surgery, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start10 Apr 2019
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enilson Antonio Sallum, University of Campinas, Brazil
- Investigators
- Enilson A Sallum, PhD, Study chair, Piracicaba Dental School, State University of CampinasFelipe T Galvão, PhD Student, Principal investigator, Piracicaba Dental School, State University of CampinasThayane C Businari, PhD Student, Principal investigator, Piracicaba Dental School, State University of CampinasRaíssa Micaella M Machado, PhD, Principal investigator, Piracicaba Dental School, State University of CampinasAltair Antoninha D Cury, PhD, Principal investigator, Piracicaba Dental School, State University of CampinasMárcio Z Casati, PhD, Principal investigator, Piracicaba Dental School, State University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986164
- Sponsor's protocol ID
- 09409619.3.0000.5418
- Status last verified
- Mar 2025
- First submitted
- 11 Jun 2019
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implants Immediately Installed in Esthetic Area With Computer-guided Surgery: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03986164
- Acronym / sponsor ID
- 09409619.3.0000.5418
- Conditions
- Dental Implants
- Keywords
- Guided Surgery, Linear Shifts, Angular Shifts, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Guided surgery (GS) | Active comparator | Device: Guided surgery with bovine spongious bone substituteInstallation of dental implant with the aid of the virtually planned guide by means of specific software |
| Conventional surgery (CS) | Active comparator | Device: Conventional surgery with bovine spongious bone substituteInstallation of dental implant performed freehand using a conventional surgical guide made by study models |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided surgery with bovine spongious bone substituteA 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 | Guided surgery (GS) |
| Conventional surgery with bovine spongious bone substituteThe 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. | Device | Conventional surgery (CS) |
Primary outcome
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.
3 secondary outcomes
Relative gingival margin position
Time frame: Immediately after surgery, 6 months, 12 months
Peri-implant probing depth
Time frame: Immediately after surgery, 6 months, 12 months
Relative clinical attachment level
Time frame: Immediately after surgery, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enilson A Sallum, PhD study chair
Piracicaba Dental School, State University of Campinas
Felipe T Galvão, PhD Student principal investigator
Piracicaba Dental School, State University of Campinas
Thayane C Businari, PhD Student principal investigator
Piracicaba Dental School, State University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided surgery with bovine spongious bone substitute and Conventional surgery with bovine spongious bone substitute in people with Dental Implants, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Position of the implant (time frame: Baseline, 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.