SmileDent Kft.
Szeged, 6724, Hungary
NCT Number: NCT06034171
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. This medical device provides the opportunity to to replace partial or complete missing teeth. Device material: Ti-6Al-4V Device surface protection: Corundum Blasting and
1. phosphate surface treatment or 2. hydroxylapatite surface treatment
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Szeged, 6724, Hungary
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 the implants are the same, the same device with different surface materilas.
"A" treatment: Implant with phosphate surface treatment is the lower one in the right side of the jawbone, with hydroxylapatite surface treatment implant is placed in the left side of the lower jaw. "B" treatment: Implant with phosphate surface treatment in the lower jaw on the left side, the bottom is an implant with hydroxylapatite surface treatment is inserted into the right side of the jaw bone
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dental implant surgery in the lower jawbone.
Time frame: 36 months
Evaluation the difference between the two types surface treated implants osseointegration. For the measure is used the OSSTELL ISQ score.
results with the OSSTELL radio frequency device based on measurable stability values. Values can vary form 1-100, higher values mean better stability.
Time frame: 36 months
Establishing the effect of implantation and subsequent prosthetic intervention on the volunteers long-term quality of life based on the scales of the OHIP questionnaire (surface treatment-independent). long-term quality of life based on the scales of the OHIP questionnaire (surface treatment-independent). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. The domain scores can range from 0 to 8. Higher OHIP-14 scores indicate worse and lower scores indicate better OHRQol
Time frame: 36 months
Determining the long-term difference between different implants in relation to bone erosion around the implant (radiological based on measurements).
SmileDent Kft.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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