A Study of a Surgical Guide for Dental Implantology

NCT03854162 | Completed DMC

• 1 other identifier: IMP SMART 002
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, adaptive, parallel study with four arms, which seeks to compare the accuracy of freehand and guided dental implantation surgeries. The basis of the comparison in each case is a digital plan, and that digital plan is compared to the actual postoperative status by computerized, three dimensional analysis.

Conditions

Dental Implantation, Endosseous; Dental Implants; Minimally Invasive Surgical Procedures; Surgery, Oral; Surgery, Computer-Assisted

Outcome Measures

Primary Outcomes (1)

• Angle deviation

  The angle closed by the principal axis of the digitally implant as planned and the actual implant as placed expressed in degrees.

  3 months

Secondary Outcomes (6)

• Apical deviation

  3 months

• Hex deviation (also known as coronal deviation)

  3 months

• Volume overlap

  3 months

• Adverse events

  6 months

• Volunteer satisfaction

  6 months

Study Arms (4)

FREEHAND

ACTIVE COMPARATOR

For these cases, the regular protocol of the study site is observed. The operator has the plan at their disposal projected on a screen in the operating theater. The preparation of the bony bed and the insertion of the implant are performed freehand, without any guidance. The positions and directions are determined with the naked eye, observing the plan projected on the screen. At the end of the operation, the operation site is checked, hemostasis is provided, and the operator records the operation in the source documentation. 2±1 days later, a postoperative CT scan is taken. A follow-up visit is due 14±2 weeks later, after the osseointegration period.

Device: SMART Guide

PILOT

ACTIVE COMPARATOR

The SMART Guide surgical template is applied only in the initial phase of the operation. After having prepared soft tissue access, the template is placed, and only one drilling is performed through its sleeve, with the so-called pilot drill. The resulting borehole serves as directional guidance for the drills applied later in the process. Further drilling and implant insertion are both performed freehand. At the end of the operation, the operation site is checked, hemostasis is provided, and the operator records the operation in the source documentation. 2±1 days later, a postoperative CT scan is taken. A follow-up visit is due 14±2 weeks later, after the osseointegration period.

Device: SMART Guide

PARTIAL GUIDE

ACTIVE COMPARATOR

The only non-guided step is implant insertion, that is, all drilling happens through the SMART Guide surgical template. After having prepared soft tissue access, the guide is placed, and all drillings are performed through it, according to the surgical protocol. Here the depth of the bony bed is also determined, as the sleeve does not allow the drill to move any deeper than planned. At the end of the operation, the operation site is checked, hemostasis is provided, and the operator records the operation in the source documentation. 2±1 days later, a postoperative CT scan is taken. A follow-up visit is due 14±2 weeks later, after the osseointegration period.

Device: SMART Guide

FULL GUIDE

ACTIVE COMPARATOR

The SMART Guide surgical template is used for all steps of the operation, including the insertion of the implant. Apart from this, the procedure is exactly the same as described under "partial guide".

Device: SMART Guide

Interventions

SMART Guide DEVICE

The device manufactured according to a digital plan based on patient anatomy. Guiding sleeves are used, through which bone drills are applied. These sleeves sit in a plastic template that is a negative of the patient's dentition, so that the guide is properly stabilized during the operation. The position of the sleeves is calculated from the surgical plan in a way that they guide the drills in the planned position.The material of the template is medical plastic, the sleeves are made of medical steel.The device is applied by the dentist during the implant surgery. The template is placed on the remaining dentition of the patient and stabilized this way. By this, the sleeves are also stabilized in their planned position. Access through the soft tissue can be prepared through the given sleeve with a circular trephine, but the system also supports flap surgery. As access has been established, the dentist performs the surgical protocol as planned.

FREEHAND; FULL GUIDE; PARTIAL GUIDE; PILOT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female volunteers between 18 and 75 years of age
• Partial edentulousness of the mandible or maxilla
• Clinical situation fit for implantation as judged by the examining physician or principal investigator (satisfactory soft and hard tissue conditions and occlusion)
• The volunteer communicates well with the examiner and compliance can be expected.
• Informed consent.

You may not qualify if:

• Pregnancy or lactation. Pregnancy is defined as the period beginning with conception and ending with birth.
• Women in their childbearing age; by definition, any woman who - unless she uses effective contraception - can get pregnant in a physiological way. Eligibility for this study presupposes that the female subject will use effective contraception until 4 weeks after the end of her participation in the study. Effective contraception is defined as any of the following:
• Barrier method: condom or diaphragm or cervical cap with spermicide. Note that spermicide in itself is not a barrier!
• Full abstinence (if this is acceptable for the subject). Periodic abstinence, like the calendar- and temperature-based methods and interrupted intercourse are not acceptable.
• Female sterilization: bilateral oophorectomy w/wo histerectomy or tubal ligation at least six weeks before participation in the study.
• Sterilization of the male partner: vasectomy (no spermia in the ejaculate). The only partner of the participating female can be a male who has undergone vasectomy.
• Hormonal contraception (oral, injection, or implanted); intrauterine device (IUD) or intrauterine system (IUS).
• Any disease (including but not exclusively the diseases of metabolism, hematological diseases, diseases of the liver, the kidneys, the lungs, the nervous system, the endocrine organs, the heart and the intestines and infectious diseases) that, in the principal investigator's opinion, has a significant effect on the subject's general health and/or means an unacceptable risk factor for the person to receive implant treatment.
• Known HIV, Hepatitis B or Hepatitis C infection.
• Any internal or psychiatric disease that, in the opinion of the principal investigator, would risk compliance with the instructions or participation until the end of the study.
• Participation in an experimental study or trial within four weeks before the randomization, or within five times the half-life of the experimental agent (whichever is longer)
• Known allergy to any component of the implant or the implant guide
• Limited mouth opening, which, in the examiner's opinion, would risk the success of the intervention
• Increased gag reflex, poor tolerance of intraoral manipulation
• Radiotherapy, irradiation of the mandible or the maxilla (either at the time of screening or in the past)

Sponsors & Collaborators

• Szeged University: lead
• Alpha - Bio Tec Ltd.: collaborator
• dicomLAB Ltd.: collaborator

Study Sites (1)

University of Szeged, Department of Oral and Maxillofacial Surgery

Szeged, 6725, Hungary

Location

Related Publications (16)

• Smeets R, Stadlinger B, Schwarz F, Beck-Broichsitter B, Jung O, Precht C, Kloss F, Grobe A, Heiland M, Ebker T. Impact of Dental Implant Surface Modifications on Osseointegration. Biomed Res Int. 2016;2016:6285620. doi: 10.1155/2016/6285620. Epub 2016 Jul 11.

  PMID: 27478833 BACKGROUND

• Yeo IS. Reality of dental implant surface modification: a short literature review. Open Biomed Eng J. 2014 Oct 31;8:114-9. doi: 10.2174/1874120701408010114. eCollection 2014.

  PMID: 25400716 BACKGROUND

• Albrektsson T, Wennerberg A. Oral implant surfaces: Part 2--review focusing on clinical knowledge of different surfaces. Int J Prosthodont. 2004 Sep-Oct;17(5):544-64.

  PMID: 15543911 BACKGROUND

• Albrektsson T, Wennerberg A. Oral implant surfaces: Part 1--review focusing on topographic and chemical properties of different surfaces and in vivo responses to them. Int J Prosthodont. 2004 Sep-Oct;17(5):536-43.

  PMID: 15543910 BACKGROUND

• Mohammed Ibrahim M, Thulasingam C, Nasser KS, Balaji V, Rajakumar M, Rupkumar P. Evaluation of design parameters of dental implant shape, diameter and length on stress distribution: a finite element analysis. J Indian Prosthodont Soc. 2011 Sep;11(3):165-71. doi: 10.1007/s13191-011-0095-4. Epub 2011 Aug 20.

  PMID: 22942576 BACKGROUND

• Ryu HS, Namgung C, Lee JH, Lim YJ. The influence of thread geometry on implant osseointegration under immediate loading: a literature review. J Adv Prosthodont. 2014 Dec;6(6):547-54. doi: 10.4047/jap.2014.6.6.547. Epub 2014 Dec 17.

  PMID: 25551016 BACKGROUND

• Madi M, Zakaria O, Ichinose S, Kasugai S. Effect of Induced Periimplantitis on Dental Implants With and Without Ultrathin Hydroxyapatite Coating. Implant Dent. 2016 Feb;25(1):39-46. doi: 10.1097/ID.0000000000000331.

  PMID: 26384099 BACKGROUND

• Gupta S, Patil N, Solanki J, Singh R, Laller S. Oral Implant Imaging: A Review. Malays J Med Sci. 2015 May-Jun;22(3):7-17.

  PMID: 26715891 BACKGROUND

• Fayaz A, Geramy A, Memari Y, Rahmani Z. Effects of Length and Inclination of Implants on Terminal Abutment Teeth and Implants in Mandibular CL1 Removable Partial Denture Assessed by Three-Dimensional Finite Element Analysis. J Dent (Tehran). 2015 Oct;12(10):739-46.

  PMID: 27252757 BACKGROUND

• Memari Y, Geramy A, Fayaz A, Rezvani Habib Abadi S, Mansouri Y. Influence of Implant Position on Stress Distribution in Implant-Assisted Distal Extension Removable Partial Dentures: A 3D Finite Element Analysis. J Dent (Tehran). 2014 Sep;11(5):523-30. Epub 2014 Sep 30.

  PMID: 25628678 BACKGROUND

• Sagat G, Yalcin S, Gultekin BA, Mijiritsky E. Influence of arch shape and implant position on stress distribution around implants supporting fixed full-arch prosthesis in edentulous maxilla. Implant Dent. 2010 Dec;19(6):498-508. doi: 10.1097/ID.0b013e3181fa4267.

  PMID: 21119354 BACKGROUND

• Behnaz E, Ramin M, Abbasi S, Pouya MA, Mahmood F. The effect of implant angulation and splinting on stress distribution in implant body and supporting bone: A finite element analysis. Eur J Dent. 2015 Jul-Sep;9(3):311-318. doi: 10.4103/1305-7456.163235.

  PMID: 26430356 BACKGROUND

• Guerrero ME, Jacobs R, Loubele M, Schutyser F, Suetens P, van Steenberghe D. State-of-the-art on cone beam CT imaging for preoperative planning of implant placement. Clin Oral Investig. 2006 Mar;10(1):1-7. doi: 10.1007/s00784-005-0031-2. Epub 2006 Feb 16.

  PMID: 16482455 BACKGROUND

• Menchini Fabris GB, Gelpi F, Giammarinaro E, Velasco Ortega E, Marconcini S, Covani U. A novel CAD/CAM-based surgical template for mandibular osteoplasty and guided implant insertion. J Biol Regul Homeost Agents. 2017 APR-JUN;31(2 Suppl. 2):99-106.

  PMID: 28702970 BACKGROUND

• Bover-Ramos F, Vina-Almunia J, Cervera-Ballester J, Penarrocha-Diago M, Garcia-Mira B. Accuracy of Implant Placement with Computer-Guided Surgery: A Systematic Review and Meta-Analysis Comparing Cadaver, Clinical, and In Vitro Studies. Int J Oral Maxillofac Implants. 2018 January/February;33(1):101-115. doi: 10.11607/jomi.5556. Epub 2017 Jun 20.

  PMID: 28632253 BACKGROUND

• Tahmaseb A, Wismeijer D, Coucke W, Derksen W. Computer technology applications in surgical implant dentistry: a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:25-42. doi: 10.11607/jomi.2014suppl.g1.2.

  PMID: 24660188 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 26, 2019
• Study Start: August 17, 2018
• Primary Completion: November 30, 2018
• Study Completion: February 28, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

HU (1)