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| Name | Class |
|---|---|
| S.G.S International Kft. | UNKNOWN |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (study implant on the right side) | Experimental | Implant with phosphate surface device in the right side of the lower jawbone, and the hydroxylapatite surface treatment implant is placed in the left side of the lower jaw. |
|
| Group B (study implant on the left side) | Experimental | Implant with phosphate surface device for the lower jaw on the left side, and the implant with hydroxylapatite surface treatment is inserted into the right side of the jawbone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dental implant | Device | Dental implant surgery in the lower jawbone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of OSSTELL ISQ score (for the degree of osseointegration indicator) | 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. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Volunteer-Quality of Life (OHIP Scale Scores) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Márk Antal, Dr. habil. | Szeged University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SmileDent Kft. | Szeged | 6724 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25503901 | Background | Derks J, Hakansson J, Wennstrom JL, Tomasi C, Larsson M, Berglundh T. Effectiveness of implant therapy analyzed in a Swedish population: early and late implant loss. J Dent Res. 2015 Mar;94(3 Suppl):44S-51S. doi: 10.1177/0022034514563077. Epub 2014 Dec 11. | |
| 25370914 | Background | van Velzen FJ, Ofec R, Schulten EA, Ten Bruggenkate CM. 10-year survival rate and the incidence of peri-implant disease of 374 titanium dental implants with a SLA surface: a prospective cohort study in 177 fully and partially edentulous patients. Clin Oral Implants Res. 2015 Oct;26(10):1121-8. doi: 10.1111/clr.12499. Epub 2014 Nov 5. |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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two arms, split-mouth, randomized
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| 36 months |
| Bone resorption measured mesially and distally in millimeters | Determining the long-term difference between different implants in relation to bone erosion around the implant (radiological based on measurements). | 36 months |
| 28239830 | Background | De Angelis F, Papi P, Mencio F, Rosella D, Di Carlo S, Pompa G. Implant survival and success rates in patients with risk factors: results from a long-term retrospective study with a 10 to 18 years follow-up. Eur Rev Med Pharmacol Sci. 2017 Feb;21(3):433-437. |
| 16618502 | Background | Wang H, Eliaz N, Xiang Z, Hsu HP, Spector M, Hobbs LW. Early bone apposition in vivo on plasma-sprayed and electrochemically deposited hydroxyapatite coatings on titanium alloy. Biomaterials. 2006 Aug;27(23):4192-203. doi: 10.1016/j.biomaterials.2006.03.034. Epub 2006 Apr 18. |
| 19409870 | Background | Eliaz N, Shmueli S, Shur I, Benayahu D, Aronov D, Rosenman G. The effect of surface treatment on the surface texture and contact angle of electrochemically deposited hydroxyapatite coating and on its interaction with bone-forming cells. Acta Biomater. 2009 Oct;5(8):3178-91. doi: 10.1016/j.actbio.2009.04.005. Epub 2009 Apr 10. |
| 21611792 | Background | Eliaz N, Ritman-Hertz O, Aronov D, Weinberg E, Shenhar Y, Rosenman G, Weinreb M, Ron E. The effect of surface treatments on the adhesion of electrochemically deposited hydroxyapatite coating to titanium and on its interaction with cells and bacteria. J Mater Sci Mater Med. 2011 Jul;22(7):1741-52. doi: 10.1007/s10856-011-4355-y. Epub 2011 May 25. |
| 18563813 | Background | Eliaz N, Kopelovitch W, Burstein L, Kobayashi E, Hanawa T. Electrochemical processes of nucleation and growth of calcium phosphate on titanium supported by real-time quartz crystal microbalance measurements and X-ray photoelectron spectroscopy analysis. J Biomed Mater Res A. 2009 Apr;89(1):270-80. doi: 10.1002/jbm.a.32129. |
| 17051536 | Background | Eliaz N, Eliyahu M. Electrochemical processes of nucleation and growth of hydroxyapatite on titanium supported by real-time electrochemical atomic force microscopy. J Biomed Mater Res A. 2007 Mar 1;80(3):621-34. doi: 10.1002/jbm.a.30944. |
| 19251497 | Background | Lakstein D, Kopelovitch W, Barkay Z, Bahaa M, Hendel D, Eliaz N. Enhanced osseointegration of grit-blasted, NaOH-treated and electrochemically hydroxyapatite-coated Ti-6Al-4V implants in rabbits. Acta Biomater. 2009 Jul;5(6):2258-69. doi: 10.1016/j.actbio.2009.01.033. Epub 2009 Feb 3. |
| 29899969 | Background | Fernandez de Grado G, Keller L, Idoux-Gillet Y, Wagner Q, Musset AM, Benkirane-Jessel N, Bornert F, Offner D. Bone substitutes: a review of their characteristics, clinical use, and perspectives for large bone defects management. J Tissue Eng. 2018 Jun 4;9:2041731418776819. doi: 10.1177/2041731418776819. eCollection 2018 Jan-Dec. |
| 2999379 | Background | Desjardins RP. Hydroxyapatite for alveolar ridge augmentation: indications and problems. J Prosthet Dent. 1985 Sep;54(3):374-83. doi: 10.1016/0022-3913(85)90556-6. |
| 29608793 | Background | Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10. |
| 38627712 | Derived | Antal MA, Kiscsatari R, Braunitzer G, Piffko J, Varga E, Eliaz N. Assessment of a novel electrochemically deposited smart bioactive trabecular coating (SBTC(R)): a randomized controlled clinical trial. Head Face Med. 2024 Apr 16;20(1):24. doi: 10.1186/s13005-024-00426-0. |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |