Clinical trial NCT04854239: Accuracy of Half-guided Implant Placement
Official title: Accuracy of Half-guided Implant Placement With Machine-driven or Manual Insertion: a Prospective, Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Partial-edentulism
Keywords: dental implants
computer-assisted surgery
guided surgery
accuracy
machine driven implant insertion
manual implant insertion
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: NSK Europe GmbH
name: Botiss Medical AG
name: Institut Straumann AG
name: Dicomlab Kft.
name: Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006)
name: Excellence Program of the Ministry for Innovation and Technology in Hungary
First posted: 2021-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 29
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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

Primary outcomes:
measure: Global coronal implant position deviation
timeFrame: 3 months after implant placement
measure: Global apical implant position deviation
timeFrame: 3 months after implant placement
measure: Horizontal coronal implant position deviation
timeFrame: 3 months after implant placement
measure: Horizontal apical implant position deviation
timeFrame: 3 months after implant placement
measure: Angular implant position deviation
timeFrame: 3 months after implant placement
Secondary outcomes:
measure: Implant insertion torque
timeFrame: During implant insertion
measure: Implant insertion torque
timeFrame: During implant insertion
measure: Duration of implant insertion
timeFrame: During implant insertion
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Department of Periodontology
Study officials:
References:
citation: Orban K, Varga E Jr, Windisch P, Braunitzer G, Molnar B. Accuracy of half-guided implant placement with machine-driven or manual insertion: a prospective, randomized clinical study. Clin Oral Investig. 2022 Jan;26(1):1035-1043. doi: 10.1007/s00784-021-04087-0. Epub 2021 Aug 16.