Accuracy of Computer-assisted Template-based Implant Placement Using Conventional or Digital Impression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Proper implant position has a significant impact in esthetic and functional outcomes of implant-supported restorations. Computer-assisted template-based implant placement (guided surgery) have become increasingly popular due to improved planning and the higher transfer accuracy of the virtual plan to the surgical site compared with freehand insertion or freehand final drilling. Digital impressions replace the need for traditional materials that can be inconvenient and messy for patients. To the best of our knowledge, at the time of planning this study, there were no published RCTs evaluating a fully digital approach for computer-assisted template-based implant placement.

The aim of the present study is to compare early implant failure, template-related complications, and virtual planning accuracy of computer-assisted template-based implant placement using conventional impression and scan model or digital impression.

The null hypothesis is that there will be no difference between these interventions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Accuracy of Static Computer-assisted Implant Surgery in Distal Free-end Scenarios

NCT06404385

Dental Implant Computer-assisted

COMPLETED NA

Sleeves Versus Sleeveless Template

NCT03641365

Guided Surgery Accuracy Dental Implant Failed Complications

COMPLETED NA

Dynamic Guided Implant Surgery VS Static Guided Surgery.

NCT06417788

Partially Edentulous Patients Bone Crest of at Least 10 mm Length and 6 mm Width Patients of at Least 18 Years Old

RECRUITING NA

One-abutment One-time for Immediate Restoration Procedure in the Esthetic Zone

NCT04139512

Implant Tissue Failure

COMPLETED PHASE4

Implant/Abutment Module Stability of Original vs Compatible Connections

NCT03524872

Bone Loss, Alveolar Dental Implant Failure Nos

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Implant Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional impression

The intervention of this arm will be "conventional impression": polyether impression will be taken with a customized tray.

Group Type ACTIVE_COMPARATOR

Conventional impressions

Intervention Type PROCEDURE

In the conventional group, a polyether impression (ImpregumTM, 3M ESPE, Seefeld, Germany) will be taken with a customized tray (Diatray Top, Dental Kontor, Stockelsdorf, Germany). The impression will be poured with Gypsum IV Class Scale 5° (T6, Techim, Techim Group s.r.l., Arese, Italy) and then, the models mounted in a fully adjustable articulator (Protar Evo 7, KaVo Dental, Biberach, Germany). Afterwards, a dental wax-up will be made accordingly to the functional and esthetic requirements. Finally, master model and wax-up will be digitalized by using a lab scanner.

A surgical template will be derived from the mounted casts (conventional group) and used to place the implants using guided surgery.

Digital impression

The intervention of this arm will be "digital impression": digital impression will be taken using a CS 3600 intraoral scanner .

Group Type EXPERIMENTAL

Digital impressions

Intervention Type PROCEDURE

Patients will be randomly assigned to undergo intraoral digital impression (digital group) or conventional impression (conventional group). In the digital group, a digital impression will be taken using CS 3600 intraoral scanner (Carestream Dental LLC, Atlanta, GA, USA). The digital data (STL, STereo Lithography interface format) will be imported in a 3D design software to realize a virtual wax-up according to the functional and esthetic requirements.

A surgical template will be derived from the virtual plane (digital group) and used to place the implants using guided surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional impressions

In the conventional group, a polyether impression (ImpregumTM, 3M ESPE, Seefeld, Germany) will be taken with a customized tray (Diatray Top, Dental Kontor, Stockelsdorf, Germany). The impression will be poured with Gypsum IV Class Scale 5° (T6, Techim, Techim Group s.r.l., Arese, Italy) and then, the models mounted in a fully adjustable articulator (Protar Evo 7, KaVo Dental, Biberach, Germany). Afterwards, a dental wax-up will be made accordingly to the functional and esthetic requirements. Finally, master model and wax-up will be digitalized by using a lab scanner.

A surgical template will be derived from the mounted casts (conventional group) and used to place the implants using guided surgery.

Intervention Type PROCEDURE

Digital impressions

Patients will be randomly assigned to undergo intraoral digital impression (digital group) or conventional impression (conventional group). In the digital group, a digital impression will be taken using CS 3600 intraoral scanner (Carestream Dental LLC, Atlanta, GA, USA). The digital data (STL, STereo Lithography interface format) will be imported in a 3D design software to realize a virtual wax-up according to the functional and esthetic requirements.

A surgical template will be derived from the virtual plane (digital group) and used to place the implants using guided surgery.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* fully or partially edentulous patient, aged 18 years or older, able to sign an informed consent, in need of an implant-supported fixed restoration will be considered eligible for this study. Any potential implant locations based on individual patient requirements will be considered eligible in the present trial. No set location or group of locations will be excluded.

Exclusion Criteria

* general medical contraindication to oral surgery (American Society of Anesthesiologist, ASA, class III or IV); irradiation in the head and neck area less than one year before implantation; psychiatric problems; alcohol or drug abuse; pregnant or nursing; untreated periodontitis; severe bruxism or clenching; uncontrolled diabetes; poor oral hygiene and motivation; and inability to complete the follow-up.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes