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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04854239
Other study ID # Accuracy-Semmelweis-Perio
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2017
Est. completion date January 31, 2019

Study information

Verified date April 2021
Source Semmelweis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Implant insertion with half-guided surgical protocol was utilized by surgical motor (machine-driven group) or torque wrench (manual group) in the maxilla. Forty patients were randomly divided in two study groups; 20 implants were inserted with a surgical motor and 20 implants with a torque wrench. After the healing period, accuracy comparison method between planned and actual implant positions was performed based on digital intraoral scan. Coronal, apical and angular deviation parameters, insertion time and maximum insertion torque was evaluated.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Half-guided implant placement
The surgery was performed under local anaesthesia in both groups, half-guided implant placement was carried out based on randomization.

Locations

Country Name City State
Hungary Semmelweis University Department of Periodontology Budapest

Sponsors (7)

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

Country where clinical trial is conducted

Hungary, 

Outcome

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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