Evaluation of the Related Factors Influencing the Stability of Dental Implants

NCT ID: NCT02733861

Last Updated: 2018-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-12-31

Brief Summary

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With the development of oral medicine,dental implants has become a very popular solution to remediate the loss of teeth and dental rehabilitation. For the last few decades, the immediate loading protocol have become more and more popular because the increasing demands of shortened treatment time. Implant stability is considered one of the most important parameters in implant dentistry. It affects the healing and successful osseointegration of implants. For any implant procedure, successful implant integration is a prerequisite criterion, which depends on a series of procedure-related and patient-dependent factors. It also has been considered that preoperative measurement is critical and may give valuable information to predict loading time and survival of the implants.

In this clinical study, the samples were collected from patients with single teeth missing who came from the department of prosthodontics from the School of Stomatology of the Fourth Military Medical University.The prospective cohort study was used to investigate the correlation between different factors and the early stability of the implants. And then, using the correlation between different factors and the early implant stability gives predictable data about implant stability and then evaluate the accuracy and reliability.

Detailed Description

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Ethical and institutional approval was obtained from the study institution. From May 2015 to May 2017, teeth missing consecutive patients requiring implant treatment consented to participate in this study to investigate the correlation between implant stability and bone density.

Cone beam computed tomography (CBCT) was used for preoperative radiological evaluation of the jawbone for each patient, and then bone density in Houndsfield units scale was assessed by SimPlant Pro 11.04 software. Immediately after the implant placement and 12 weeks later, stability measurements were performed with Osstell™ Mentor.The captured data was represented in a quantitative unit called Implant Stability Quotient (ISQ) on a scale from 1 to 100 and averaged for each implant.

The descriptive statistical methods were used to show the differences in bone density and ISQ values among location, gender, age and implant diameter variables. Mann-whitney test was used for comparison of HU values and ISQ values between different age and gender groups. Kruskal-Wallis test was used for comparison of HU values and ISQ values between different location and implant diameter groups. The changes of ISQ values over time were compared using Wilcoxon signed rank test. The Spearman's rank correlation coefficient was used to investigate the correlation between ISQ values and HU values.

At last, to investigate the possible correlations between implant stability and bone density and to study the feasibility of predicting implant stability by using preoperative CBCT.

Conditions

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Teeth Missing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* the patients who had undergone tooth extraction within the previous 3 months

Exclusion Criteria

* those who required bone augmentation simultaneously with implant insertion, and patients with any systemic disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Zhang Yumei

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yumei Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of prosthetic dentistry, Stomatology hospital, Fourth Military Medical University

Locations

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Dingxin

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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Merheb J, Van Assche N, Coucke W, Jacobs R, Naert I, Quirynen M. Relationship between cortical bone thickness or computerized tomography-derived bone density values and implant stability. Clin Oral Implants Res. 2010 Jun;21(6):612-7. doi: 10.1111/j.1600-0501.2009.01880.x.

Reference Type BACKGROUND
PMID: 20666788 (View on PubMed)

Goodacre CJ, Bernal G, Rungcharassaeng K, Kan JY. Clinical complications with implants and implant prostheses. J Prosthet Dent. 2003 Aug;90(2):121-32. doi: 10.1016/S0022-3913(03)00212-9.

Reference Type RESULT
PMID: 12886205 (View on PubMed)

Fugazzotto PA. Success and failure rates of osseointegrated implants in function in regenerated bone for 72 to 133 months. Int J Oral Maxillofac Implants. 2005 Jan-Feb;20(1):77-83.

Reference Type RESULT
PMID: 15747677 (View on PubMed)

Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54.

Reference Type RESULT
PMID: 17974108 (View on PubMed)

Javed F, Romanos GE. The role of primary stability for successful immediate loading of dental implants. A literature review. J Dent. 2010 Aug;38(8):612-20. doi: 10.1016/j.jdent.2010.05.013. Epub 2010 Jun 11.

Reference Type RESULT
PMID: 20546821 (View on PubMed)

Herrmann I, Lekholm U, Holm S, Kultje C. Evaluation of patient and implant characteristics as potential prognostic factors for oral implant failures. Int J Oral Maxillofac Implants. 2005 Mar-Apr;20(2):220-30.

Reference Type RESULT
PMID: 15839115 (View on PubMed)

Turkyilmaz I, Tozum TF, Tumer C, Ozbek EN. Assessment of correlation between computerized tomography values of the bone, and maximum torque and resonance frequency values at dental implant placement. J Oral Rehabil. 2006 Dec;33(12):881-8. doi: 10.1111/j.1365-2842.2006.01692.x.

Reference Type RESULT
PMID: 17168930 (View on PubMed)

Aksoy U, Eratalay K, Tozum TF. The possible association among bone density values, resonance frequency measurements, tactile sense, and histomorphometric evaluations of dental implant osteotomy sites: a preliminary study. Implant Dent. 2009 Aug;18(4):316-25. doi: 10.1097/ID.0b013e31819ecc12.

Reference Type RESULT
PMID: 19667820 (View on PubMed)

Farre-Pages N, Auge-Castro ML, Alaejos-Algarra F, Mareque-Bueno J, Ferres-Padro E, Hernandez-Alfaro F. Relation between bone density and primary implant stability. Med Oral Patol Oral Cir Bucal. 2011 Jan 1;16(1):e62-7. doi: 10.4317/medoral.16.e62.

Reference Type RESULT
PMID: 20711163 (View on PubMed)

Monje A, Suarez F, Garaicoa CA, Monje F, Galindo-Moreno P, Garcia-Nogales A, Wang HL. Effect of location on primary stability and healing of dental implants. Implant Dent. 2014 Feb;23(1):69-73. doi: 10.1097/ID.0000000000000019.

Reference Type RESULT
PMID: 24384740 (View on PubMed)

Turkyilmaz I, Tumer C, Ozbek EN, Tozum TF. Relations between the bone density values from computerized tomography, and implant stability parameters: a clinical study of 230 regular platform implants. J Clin Periodontol. 2007 Aug;34(8):716-22. doi: 10.1111/j.1600-051X.2007.01112.x.

Reference Type RESULT
PMID: 17635248 (View on PubMed)

Hong J, Lim YJ, Park SO. Quantitative biomechanical analysis of the influence of the cortical bone and implant length on primary stability. Clin Oral Implants Res. 2012 Oct;23(10):1193-7. doi: 10.1111/j.1600-0501.2011.02285.x. Epub 2011 Sep 29.

Reference Type RESULT
PMID: 22092387 (View on PubMed)

Calvo-Guirado JL, Lopez-Lopez PJ, Perez-Albacete Martinez C, Javed F, Granero-Marin JM, Mate Sanchez de Val JE, Ramirez Fernandez MP. Peri-implant bone loss clinical and radiographic evaluation around rough neck and microthread implants: a 5-year study. Clin Oral Implants Res. 2018 Jun;29(6):635-643. doi: 10.1111/clr.12775. Epub 2016 Jan 7.

Reference Type RESULT
PMID: 26744262 (View on PubMed)

Other Identifiers

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IRB-REV-2016012

Identifier Type: -

Identifier Source: org_study_id

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