Status:
COMPLETED
Clinical Study of Implants With Modified Surface Treatment
Lead Sponsor:
SmileDent Kft.
Collaborating Sponsors:
S.G.S International Kft.
Conditions:
Dental Implant
Hydroxyapatite
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The observed medical device in this study were SGS P7D Dental implant. The device replaces the lost tooth root, and provides support for the dental bridges and crowns, or overdenture replacements. Thi...
Detailed Description
A prospective, randomized, two-arms "split-mouth" study. The two arms: right and left of the same mandible of the same volunteer with a different surface treatment, but every other circumstances of th...
Eligibility Criteria
Inclusion
- complete lack of teeth in the lower jaw
- decision of the investigator: the patient is appropriate for implantation, clinical conditions are sufficient (adequate soft tissue and bone conditions and occlusal position;)
- the patient's consciousness is clear, understand the planned intervention.
- the patient communicates well with the examiner and is able to understand and comply with the requirements of the test plan.
- witten informed consent
Exclusion
- Pregnant or lactating women
- Women of childbearing potential, unless she uses effective birth control until the completion of the final radiological examination, and for another 4 weeks after that.
- A disease (including, but not limited to metabolic, hematological, kidney, liver, lung, neurological, endocrine, cardiac, infectious and gastrointestinal disease), which -in the opinion of the investigator- significantly affects the health of the examined person and/or exposes to an unacceptably high risk the person receiving the implantation treatment.
- Malignant disease in the medical history in the preceding 24 months.
- Known HIV, hepatitis B or hepatitis C, or any other considered viral infection relevant by the examiner known at the tome of randomization
- A medical or psychiatric illness which, in the opinion of the investigator, excludes that the participant adheres to the protocol, or complete the study according to the protocol.
- Participation in an other interventional clinical study within 6 months prior to treatment.
- Known allergy to the implant or to the invetigational template or any of its components.
- Limitation of mouth opening, which make unpossible to complete the procedure, based on the opinion of the investigator
- Increased pharyngeal reflex, reduced ability to tolerate intraoral manipulation
- Radiotherapy, previous irradiation of the jawbones
- INR \> 2.5
- Immunosuppressed patient
- previous or current bisphosphonate treatment
- Known alcohol or drug abuse
- Heavy smoking (≥ 20 cigarettes per day, or another form of smoking, used in an equivalent amount)
- Untreated periodontitis
- Local infection of the implant in the planned area
- Lack of dental hygiene, e.g. not removed radixes, plaque and calculus, or radiologically detectable potential periapical focus (also in asymptomatic case )
- Insufficient or poor oral hygiene
- Transient infectious state, with or without fever
Key Trial Info
Start Date :
June 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06034171
Start Date
June 13 2019
End Date
December 31 2023
Last Update
January 9 2026
Active Locations (1)
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1
SmileDent Kft.
Szeged, Hungary, 6724