Accuracy of Half-guided Implant Placement With Machine-driven or Manual Insertion: a Prospective, Randomized Clinical Study

Semmelweis University1 site in 1 country40 target enrollmentJanuary 1, 2017

ConditionsPartial-edentulism

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Partial-edentulism
Sponsor: Semmelweis University
Enrollment: 40
Locations: 1
Primary Endpoint: Global apical implant position deviation
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

January 1, 2017

End Date

January 31, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Semmelweis University

Responsible Party

Principal Investigator

Balint Molnar

Dr. Balint Molnar DMD, PhD, associate professor

Semmelweis University

Eligibility Criteria

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