Clinical Study of Implants With Modified Surface Treatment

NCT06034171 | Completed DMC

• 1 other identifier: SM-SGS_001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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. 1.phosphate surface treatment or
2. 2.hydroxylapatite surface treatment

Conditions

Dental Implant; Hydroxyapatite

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Volunteer-Quality of Life (OHIP Scale Scores)

  36 months

• Bone resorption measured mesially and distally in millimeters

  36 months

Study Arms (2)

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.

Device: dental implant

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.

Device: dental implant

Interventions

dental implant DEVICE

Dental implant surgery in the lower jawbone.

Group A (study implant on the right side); Group B (study implant on the left side)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SmileDent Kft.: lead
• S.G.S International Kft.: collaborator

Study Sites (1)

SmileDent Kft.

Szeged, 6724, Hungary

Location

Related Publications (13)

• 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.

  PMID: 25503901 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.

  PMID: 25370914 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.

  PMID: 28239830 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.

  PMID: 16618502 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.

  PMID: 19409870 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.

  PMID: 21611792 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.

  PMID: 18563813 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.

  PMID: 17051536 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.

  PMID: 19251497 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.

  PMID: 29899969 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.

  PMID: 2999379 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.

  PMID: 29608793 BACKGROUND

• 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.

  PMID: 38627712 DERIVED

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Márk Antal, Dr. habil.

  Szeged University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two arms, split-mouth, randomized

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: June 13, 2019
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)