NCT02418117

Brief Summary

The investigators' aim is to evaluate the accuracy of the stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level. Clinical relevance:

  • To identify factors influencing the surgical template imprecision.
  • To overcome risk factors for surgical template imprecision.
  • To suggest improvements for highly accuracy of the surgical template especially for immediate loading and avoiding the injury of anatomical structures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

April 9, 2015

Last Update Submit

January 26, 2016

Conditions

Jaw, Edentulous

Keywords

Stereolitographic guideflapless surgerydental implants

Outcome Measures

Primary Outcomes (1)

  • Measurements of accuracy after implants placement at coronal and apical level

    Measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal, oral, mesial and distal.

    average 10 days

Study Arms (1)

Stereolitographic template's accuracy

EXPERIMENTAL

Evaluating the accuracy of stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level

Other: Stereolitographic template

Interventions

Stereolitographic templateOTHER

Flapless (atraumatic) dental implants insertion with the aid of a stereolitographic template.

Stereolitographic template's accuracy

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fully or partially edentulous patients,
  • good general healty with no contraindications for implant surgery,
  • acceptance of dental implant treatment,
  • acceptance of at least 2 CBCT (one at treatment planning and one after surgery)

You may not qualify if:

  • limited bone volume with stadial bone graft requirement,
  • limited mouth opening (imposible to use the surgical stent),
  • parkinson desease (imposible to perform an accurate CBCT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concordia Dent Clinic

Bucharest, 041335, Romania

Location

Related Publications (4)

  • Vasak C, Kohal RJ, Lettner S, Rohner D, Zechner W. Clinical and radiological evaluation of a template-guided (NobelGuide) treatment concept. Clin Oral Implants Res. 2014 Jan;25(1):116-23. doi: 10.1111/clr.12038. Epub 2012 Sep 18.

    PMID: 22984962BACKGROUND

  • Yatzkair G, Cheng A, Brodie S, Raviv E, Boyan BD, Schwartz Z. Accuracy of computer-guided implantation in a human cadaver model. Clin Oral Implants Res. 2015 Oct;26(10):1143-9. doi: 10.1111/clr.12482. Epub 2014 Sep 15.

    PMID: 25220954BACKGROUND

  • Beretta M, Poli PP, Maiorana C. Accuracy of computer-aided template-guided oral implant placement: a prospective clinical study. J Periodontal Implant Sci. 2014 Aug;44(4):184-93. doi: 10.5051/jpis.2014.44.4.184. Epub 2014 Aug 28.

    PMID: 25177520BACKGROUND

  • Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x.

    PMID: 23062136BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • CORINA MARILENA I CRISTACHE, DMD, PhD

    Carol Davila University of Medicine and Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Corina Marilena Cristache, DMD, PhD, senior lecturer

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 16, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

RO(1)