Accuracy of Half-guided Implant Placement

Semmelweis University

Status and phase: Completed; Phase 4

Conditions: Partial-edentulism

Treatments: Procedure: Half-guided implant placement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04854239

Accuracy-Semmelweis-Perio

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 29 to 67 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Machine-driven group

Experimental group

Description:

In the machine-driven group, after guided implant bed preparation, implant insertion was performed with contra-angled handpiece.

Treatment:

Procedure: Half-guided implant placement

Manual group

Experimental group

Description:

In the manual group, after guided implant bed preparation, implant insertion was performed with torque-wrench.

Treatment:

Procedure: Half-guided implant placement