Accuracy of Half-guided Implant Placement

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Partial-edentulism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Forty patients were treated; implant insertion with half-guided surgical protocol was utilized by surgical motor (20 patients, machine-driven group) or torque wrench (20 patients, manual group) in the maxilla.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Patients were not aware whether implant were placed with a contra-angled handpiece or with a torque wrench. 3D implant position accuracy evaluation was performed blinded, randomization sequence was revealed after analysis.

Study Groups

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Machine-driven group

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

Group Type EXPERIMENTAL

Half-guided implant placement

Intervention Type PROCEDURE

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

Manual group

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

Group Type EXPERIMENTAL

Half-guided implant placement

Intervention Type PROCEDURE

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

Interventions

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Half-guided implant placement

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

Intervention Type PROCEDURE

Other Intervention Names

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Guided implant placement

Eligibility Criteria

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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

Minimum Eligible Age

29 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes