Evaluation of the Related Factors Influencing the Stability of Dental Implants

NCT02733861 | Unknown

• 1 other identifier: IRB-REV-2016012
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Teeth Missing

Keywords

dental implant; stability; implant stability quotient

Outcome Measures

Primary Outcomes (2)

• Implant stability quotient (ISQ) was tested by Osstell™ Mentor

  The transducer probe was aimed at the small magnet on top of the SmartPeg at a distance of 2 to 3 mm and held stable during the pulsing time until the instrument beeped and displayed the ISQ value. If two ISQ values were displayed simultaneously, their mean value was recorded. Measurements were taken twice in the buccolingual direction as well as in the mesiodistal direction. The mean of all measurements was rounded to the nearest whole number and was regarded as representative of the ISQ.

  on the day of surgery

• Implant stability quotient (ISQ) was tested by Osstell™ Mentor

  The transducer probe was aimed at the small magnet on top of the SmartPeg at a distance of 2 to 3 mm and held stable during the pulsing time until the instrument beeped and displayed the ISQ value. If two ISQ values were displayed simultaneously, their mean value was recorded. Measurements were taken twice in the buccolingual direction as well as in the mesiodistal direction. The mean of all measurements was rounded to the nearest whole number and was regarded as representative of the ISQ.

  on the 12th weeks after surgery

Secondary Outcomes (3)

• Measure the bone density of the implant locations by CBCT.

  within 10 days before surgery

• Measure the thickness of the bone around the implant by CBCT.

  immediately after the surgery

• Measure the crestal bone resorption by X-ray images

  immediately and 3 months after the surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

single teeth missing consecutive patients requiring implant treatment consented to participate in this study

You may qualify if:

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

You may not qualify if:

• those who required bone augmentation simultaneously with implant insertion, and patients with any systemic disease

Sponsors & Collaborators

• Air Force Military Medical University, China: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Dingxin

Xi'an, Shaanxi, 710032, China

Location

Related Publications (13)

• 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.

  PMID: 20666788 BACKGROUND

• 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.

  PMID: 12886205 RESULT

• 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.

  PMID: 15747677 RESULT

• 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.

  PMID: 17974108 RESULT

• 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.

  PMID: 20546821 RESULT

• 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.

  PMID: 15839115 RESULT

• 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.

  PMID: 17168930 RESULT

• 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.

  PMID: 19667820 RESULT

• 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.

  PMID: 20711163 RESULT

• 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.

  PMID: 24384740 RESULT

• 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.

  PMID: 17635248 RESULT

• 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.

  PMID: 22092387 RESULT

• 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.

  PMID: 26744262 RESULT

Study Officials

• Yumei Zhang, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 12, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)