Status:
COMPLETED
A Study of a Surgical Guide for Dental Implantology
Lead Sponsor:
Szeged University
Collaborating Sponsors:
Alpha - Bio Tec Ltd.
dicomLAB Ltd.
Conditions:
Dental Implantation, Endosseous
Dental Implants
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
Detailed Description
Osseointegration of endosseous implants has long been the focus of research in dental implantology, for obvious reasons. The use of Titanium became the standard quite soon, but it took decades of rese...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- INR\>2.5
- Immunosuppressed state
- Bisphosphonate treatment (either at the time of screening or in the past)
- Alcohol or drug abuse
- Habitual smoking
- Untreated periodontitis
- Retained root in the planned insertion site
- Local infection
- Lack of dental sanitation
- Poor oral hygiene
- Infection w/wo fever
Key Trial Info
Start Date :
August 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03854162
Start Date
August 17 2018
End Date
February 28 2019
Last Update
March 7 2019
Active Locations (1)
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1
University of Szeged, Department of Oral and Maxillofacial Surgery
Szeged, Hungary, 6725