Partial-edentulism Clinical Trial
Official title:
Accuracy of Half-guided Implant Placement With Machine-driven or Manual Insertion: a Prospective, Randomized Clinical Study
Verified date | April 2021 |
Source | Semmelweis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the present prospective randomized controlled study is to compare the accuracy of implant placement performed either with a surgical motor or a torque wrench as part of a half-guided surgical protocol after maxillary sinus floor augmentation.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 29 Years to 67 Years |
Eligibility | Inclusion Criteria: - at least one edentulous maxillary premolar or molar site treated successfully by sinus floor elevation with a xenogenic bone substitute (cerabone, botiss biomaterials, Zossen, Germany) confirmed by preoperative cone-beam computed tomography - full- mouth plaque and bleeding scores (FMPS and FMBS) <20% - good patient compliance (including willingness to participate in the follow-up procedures) - signed informed consent Exclusion Criteria: - clinically relevant diseases (e.g.: diabetes, rheumatism, cancer) - systemic steroid or bisphosphonate use - acute or chronic inflammatory processes |
Country | Name | City | State |
---|---|---|---|
Hungary | Semmelweis University Department of Periodontology | Budapest |
Lead Sponsor | Collaborator |
---|---|
Semmelweis University | Botiss Medical AG, Dicomlab Kft., Excellence Program of the Ministry for Innovation and Technology in Hungary, Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006), Institut Straumann AG, NSK Europe GmbH |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global coronal implant position deviation | Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm | 3 months after implant placement | |
Primary | Global apical implant position deviation | Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm | 3 months after implant placement | |
Primary | Horizontal coronal implant position deviation | Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm | 3 months after implant placement | |
Primary | Horizontal apical implant position deviation | Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm | 3 months after implant placement | |
Primary | Angular implant position deviation | Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm | 3 months after implant placement | |
Secondary | Implant insertion torque | Measurement: Insertion torque. Tool: torque wrech Unit: Ncm | During implant insertion | |
Secondary | Implant insertion torque | Measurement: Insertion torque. Tool: surgical motor Unit: Ncm | During implant insertion | |
Secondary | Duration of implant insertion | Measurement: Duration of implant insertion Tool: stopwatch Unit: seconds | During implant insertion |
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