Dental Implants Clinical Trial
Official title:
The Accuracy of Partially or Fully Guided Dental Implantation Performed With Dental Implantological Surgical Guide as Compared to Freehand Dental Implantation
Verified date | March 2019 |
Source | Szeged University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 119 |
Est. completion date | February 28, 2019 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Male and female volunteers between 18 and 75 years of age 2. Partial edentulousness of the mandible or maxilla 3. Clinical situation fit for implantation as judged by the examining physician or principal investigator (satisfactory soft and hard tissue conditions and occlusion) 4. The volunteer communicates well with the examiner and compliance can be expected. Informed consent. Exclusion Criteria: 1. Pregnancy or lactation. Pregnancy is defined as the period beginning with conception and ending with birth. 2. 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). 3. 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. 4. Known HIV, Hepatitis B or Hepatitis C infection. 5. 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. 6. 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) 7. Known allergy to any component of the implant or the implant guide 8. Limited mouth opening, which, in the examiner's opinion, would risk the success of the intervention 9. Increased gag reflex, poor tolerance of intraoral manipulation 10. Radiotherapy, irradiation of the mandible or the maxilla (either at the time of screening or in the past) 11. INR>2.5 12. Immunosuppressed state 13. Bisphosphonate treatment (either at the time of screening or in the past) 14. Alcohol or drug abuse 15. Habitual smoking 16. Untreated periodontitis 17. Retained root in the planned insertion site 18. Local infection 19. Lack of dental sanitation 20. Poor oral hygiene 21. Infection w/wo fever |
Country | Name | City | State |
---|---|---|---|
Hungary | University of Szeged, Department of Oral and Maxillofacial Surgery | Szeged |
Lead Sponsor | Collaborator |
---|---|
Szeged University | Alpha - Bio Tec Ltd., dicomLAB Ltd. |
Hungary,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Apical deviation | The deviation of the apical point of the placed implant from the apical point as planned in the three dimensional space, expressed in millimeters. | 3 months | |
Secondary | Hex deviation (also known as coronal deviation) | The angle closed by the principal axis of the digitally implant as planned and the actual implant as placed expressed in degrees (to one decimal). | 3 months | |
Secondary | Volume overlap | the overlap between the planned model implant and the placed implant as digitally Reconstructed from a postoperative cone-beam CT scan, expressed as a percentage. | 3 months | |
Secondary | Adverse events | The occurrence of adverse events, expressed as the number and seriousness of adverse events. | 6 months | |
Secondary | Volunteer satisfaction | The subjective satisfaction of volunteers as assessed by the Oral Health Impact Profile questionnaire, and a custom volunteer satisfaction questionnaire. Questionnaires administered three times during study period. | 6 months | |
Secondary | Dentist (operator) satisfaction | The subjective satisfaction of the operating dentist with the surgery as an experience, assessed by a custom questionnaire. Questionnaire administered after each surgery. | 3 months |
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