Clinical Study of Implants With Modified Surface Treatment

Dental Implant Clinical Trial

Official title:

Clinical Study of Implants With Modified Surface Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06034171
• Other study ID #: SM-SGS_001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: SmileDent Kft.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. phosphate surface treatment or

2. hydroxylapatite surface treatment

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 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Dental Implant
• Hydroxyapatite

Intervention

Device:
• dental implant
Dental implant surgery in the lower jawbone.

Locations

Country	Name	City	State
Hungary	SmileDent Kft.	Szeged

Sponsors (2)

Lead Sponsor	Collaborator
SmileDent Kft.	S.G.S International Kft.

Country where clinical trial is conducted

Hungary, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months
Secondary	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).	36 months
Secondary	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