Teeth MissingNCT02733861
Evaluation of the Related Factors Influencing the Stability of Dental Implants
An observational study of Teeth Missing, run by Air Force Military Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Teeth Missing
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Dec 2018
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: single teeth missing consecutive patients requiring implant treatment consented to participate in this study
Who may be able to join
- the patients who had undergone tooth extraction within the previous 3 months
Who cannot join
- those who required bone augmentation simultaneously with implant insertion, and patients with any systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Teeth Missing
- Keywords
- dental implant, stability, implant stability quotient
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: on the 12th weeks after surgery
Secondary outcomes (3)
Measure the bone density of the implant locations by CBCT.
Using the interactive setting on the SimplantTM software, an implant was then placed over the alveolar portion of each edentulous span to include the trabecular portion and the outer cortical shell when present. The computer was then asked to map the density of the bone around the entire circumference of each implant, with a surrounding thickness of 1 mm, which is the default setting . Multiple adjacent readings were taken within each span, where possible. Subsequently, all areas subjectively classified into each of the four qualities were pooled so that a range of Houndsfield values (HU) could be attributed to each particular quality, and a mean value was calculated in order to establish a new objective quantitative scale of bone density.
Measured: within 10 days before surgery
Measure the thickness of the bone around the implant by CBCT.
Using the interactive setting on the SimplantTM software, an implant was then placed over the alveolar portion of each edentulous span to include the trabecular portion and the outer cortical shell when present. The computer was then asked to map the density of the bone around the entire circumference of each implant, with a surrounding thickness of 1 mm, which is the default setting . Multiple adjacent readings were taken within each span, where possible. Subsequently, all areas subjectively classified into each of the four qualities were pooled so that a range of Houndsfield values (HU) could be attributed to each particular quality, and a mean value was calculated in order to establish a new objective quantitative scale of bone density.
Measured: immediately after the surgery
Measure the crestal bone resorption by X-ray images
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.
Measured: immediately and 3 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Teeth MissingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Zhang Yumei, Air Force Military Medical University, China
- Investigators
- Yumei Zhang, PhD, Principal investigator, Department of prosthetic dentistry, Stomatology hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733861
- Sponsor's protocol ID
- IRB-REV-2016012
- Status last verified
- Jun 2018
- First submitted
- 29 Mar 2016
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20666788Goodacre 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.
PubMed 12886205Fugazzotto 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.
PubMed 15747677Atsumi 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.
PubMed 17974108Javed 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.
PubMed 20546821Herrmann 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.
PubMed 15839115Turkyilmaz 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.
PubMed 17168930Aksoy 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.
PubMed 19667820Farre-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.
PubMed 20711163Monje 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.
PubMed 24384740Turkyilmaz 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.
PubMed 17635248Hong 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.
PubMed 22092387Calvo-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.
PubMed 26744262
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Related Factors Influencing the Stability of Dental Implants
- ClinicalTrials.gov ID
- NCT02733861
- Acronym / sponsor ID
- IRB-REV-2016012
- Conditions
- Teeth Missing
- Keywords
- dental implant, stability, implant stability quotient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- single teeth missing consecutive patients requiring implant treatment consented to participate in this study
Key inclusion criteria (1 listed)
- the patients who had undergone tooth extraction within the previous 3 months
Key exclusion criteria (1 listed)
- those who required bone augmentation simultaneously with implant insertion, and patients with any systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implant stability quotient (ISQ) was tested by Osstell™ Mentor
Time frame: on the day of surgery
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.
Implant stability quotient (ISQ) was tested by Osstell™ Mentor
Time frame: on the 12th weeks after surgery
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.
3 secondary outcomes
Measure the bone density of the implant locations by CBCT.
Time frame: within 10 days before surgery
Measure the thickness of the bone around the implant by CBCT.
Time frame: immediately after the surgery
Measure the crestal bone resorption by X-ray images
Time frame: immediately and 3 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Background: PubMed 20666788Merheb 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.
- Results publication: PubMed 12886205Goodacre 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.
- Results publication: PubMed 15747677Fugazzotto 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.
- Results publication: PubMed 17974108Atsumi 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.
- Results publication: PubMed 20546821Javed 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.
- Results publication: PubMed 15839115Herrmann 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.
- Results publication: PubMed 17168930Turkyilmaz 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.
- Results publication: PubMed 19667820Aksoy 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.
- Results publication: PubMed 20711163Farre-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.
- Results publication: PubMed 24384740Monje 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.
- Results publication: PubMed 17635248Turkyilmaz 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.
- Results publication: PubMed 22092387Hong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yumei Zhang, PhD principal investigator
Department of prosthetic dentistry, Stomatology hospital, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Teeth Missing, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability quotient (ISQ) was tested by Osstell™ Mentor (time frame: on the day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02733861, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.