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出境医 / 临床实验 / Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed Dental Prosthesis vs. 10 mm Implants Installed After Sinus Floor Elevation.

Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed Dental Prosthesis vs. 10 mm Implants Installed After Sinus Floor Elevation.

Study Description
Brief Summary:
Recently, 4 mm long implants with a standard diameter have been used for the restoration of the posterior edentulous mandible with favorable results. However, randomized clinical trials reporting the results from full-arch fixed dental prosthesis that included 4 mm long implants placed in the posterior regions of the maxilla have not been published yet. The aim of the present study will be to compare the survival and success rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure

Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Procedure: Placement of extra short implants Procedure: maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation Procedure: placement of standard implant Not Applicable

Detailed Description:
Two groups will be randomly prepared, the Short group and the Standard group. In the Short group, one 4 mm long and 4.1 mm in diameter implant (extra-short implant) will be installed in each side of the posterior region of the maxilla. In the Standard group, bilateral sinus floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in diameter implant (standard implant) will be installed into each augmented sinus. In the frontal region, four 10 mm long implants will be installed in both groups. Clinical assessments and x-rays will be taken at prosthesis delivering (6-8 weeks after implant installation), and after 6, 12, 18 and 24 months.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups will be randomly prepared. The Short group, one 4 mm long and 4.1 mm in diameter implant (Short implant) will be installed in each side of the posterior region of the maxilla. The standard group, bilateral sinus floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in diameter implant (Standard implant) will be installed into each augmented sinus.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: A statistician not involved in the study performed the randomization in blocks of four and the assignments have been sealed in coded and opaque envelopes that will be opened at the time of the enrollment of each patient in the study. The surgeon will be blinded about the assignment until the time of the surgery. The outcome assessor will be blinded about the protocol
Primary Purpose: Treatment
Official Title: Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed Dental Prosthesis vs. 10 mm Implants Installed After Sinus Floor Elevation. A Randomized Clinical Trial
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : December 2, 2018
Actual Study Completion Date : April 2, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Short Group
In each side of the posterior region of the maxilla, one tissue level implant, 4 mm long and 4.1 mm in diameter, will be installed
 Procedure: Placement of extra short implants
placement of an extra short implant in the posterior edentulous ridge
Experimental: Standard group
sinus floor elevation with will be performed using natural bovine bone graft as filler material and porcine dermis collagen membrane to cover the antrostomy. After 4 months of healing, one bone level implant, 10 mm long and 4.1 mm in diameter, will be installed into each augmented sinus.
 Procedure: maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation
Procedure: placement of standard implant
placement of standard implant in the posterior edentulous ridge after maxillary sinus augmentation
Outcome Measures
Primary Outcome Measures :
  1. survival rate of 4 mm implants used as distal support [ Time Frame: 24 months ]
    To compare the survival rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure.

  2. Crestal bone level [ Time Frame: 24 months ]
    Change of crestal bone level measured on intraoral x-ray applying a parallel technique from baseline (definitive prosthesis delivering) and 2-year follow-up. The distance between the implant margin and the first bone to implant contact will be measured in millimeters at the mesial and distal aspects of the Short and Standard implants.


Secondary Outcome Measures :
  1. Technical complications [ Time Frame: 24 months ]
    Any technical complications related to implants, abutments, screw loosening, prosthetic fracture or chipping of the veneer material expressed in number of occurrence.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gender identity
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Edentulous maxilla
  • Willing to receive a full arch fixed restoration in the maxilla.
  • Latest extraction at least 8 weeks before implant insertion
  • Sinus floor height included between 4 to 6 mm
  • Bone width in the distal segments sufficient to allow the insertion of a 4 mm long implant of standard diameter.
  • In the anterior maxilla (from first premolar to first premolar) bone width sufficient to allow the insertion of 10 mm long implants of standard diameter. Minor horizontal augmentations with guided bone regeneration procedures was allowed in the anterior maxilla.

the opposing arch have to present one of the following conditions:

  • natural dentition (at least 10 elements from 3.5 to 4.5)
  • Fixed dental prosthesis of at least 10 elements (from 3.5 to 4.5) supported by teeth or implants
  • Implant supported or teeth supported overdentures
  • Adequate partial removable prostheses.

Exclusion Criteria:

  • Presence of conditions requiring prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements).
  • Major systemic diseases, or medical conditions requiring prolonged use of steroids, or alcoholism or chronically drug abuse.
  • Current pregnancy or breastfeeding women
  • Smokers > 10 cigarettes per day
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Immunocompromised patients including patients infected with HIV
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
  • Patients with an ongoing or previous treatment with bisphosphonates (for at least 2 months for oral therapy or 6 months for IV injection)

Local exclusion criteria

  • Local inflammation, including untreated periodontitis
  • Pre-cancerous oral lesions
  • History of local irradiation therapy
  • Severe bruxism or clenching habits
  • Patients with inadequate oral hygiene or unmotivated for adequate oral home care
  • Previous Guided bone regeneration or Guided tissue regeneration treatment at the implant site
  • Total removable prosthesis in the lower arch
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE October 1, 2015
Actual Primary Completion Date December 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • survival rate of 4 mm implants used as distal support [ Time Frame: 24 months ]
    To compare the survival rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure.
  • Crestal bone level [ Time Frame: 24 months ]
    Change of crestal bone level measured on intraoral x-ray applying a parallel technique from baseline (definitive prosthesis delivering) and 2-year follow-up. The distance between the implant margin and the first bone to implant contact will be measured in millimeters at the mesial and distal aspects of the Short and Standard implants.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019) 		Technical complications [ Time Frame: 24 months ]
Any technical complications related to implants, abutments, screw loosening, prosthetic fracture or chipping of the veneer material expressed in number of occurrence.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed Dental Prosthesis vs. 10 mm Implants Installed After Sinus Floor Elevation.
Official Title  ICMJE Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed Dental Prosthesis vs. 10 mm Implants Installed After Sinus Floor Elevation. A Randomized Clinical Trial
Brief Summary Recently, 4 mm long implants with a standard diameter have been used for the restoration of the posterior edentulous mandible with favorable results. However, randomized clinical trials reporting the results from full-arch fixed dental prosthesis that included 4 mm long implants placed in the posterior regions of the maxilla have not been published yet. The aim of the present study will be to compare the survival and success rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure
Detailed Description Two groups will be randomly prepared, the Short group and the Standard group. In the Short group, one 4 mm long and 4.1 mm in diameter implant (extra-short implant) will be installed in each side of the posterior region of the maxilla. In the Standard group, bilateral sinus floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in diameter implant (standard implant) will be installed into each augmented sinus. In the frontal region, four 10 mm long implants will be installed in both groups. Clinical assessments and x-rays will be taken at prosthesis delivering (6-8 weeks after implant installation), and after 6, 12, 18 and 24 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two groups will be randomly prepared. The Short group, one 4 mm long and 4.1 mm in diameter implant (Short implant) will be installed in each side of the posterior region of the maxilla. The standard group, bilateral sinus floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in diameter implant (Standard implant) will be installed into each augmented sinus.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:
A statistician not involved in the study performed the randomization in blocks of four and the assignments have been sealed in coded and opaque envelopes that will be opened at the time of the enrollment of each patient in the study. The surgeon will be blinded about the assignment until the time of the surgery. The outcome assessor will be blinded about the protocol
Primary Purpose: Treatment
Condition  ICMJE Alveolar Bone Loss
Intervention  ICMJE
  • Procedure: Placement of extra short implants
    placement of an extra short implant in the posterior edentulous ridge
  • Procedure: maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation
  • Procedure: placement of standard implant
    placement of standard implant in the posterior edentulous ridge after maxillary sinus augmentation
Study Arms  ICMJE
  • Experimental: Short Group
    In each side of the posterior region of the maxilla, one tissue level implant, 4 mm long and 4.1 mm in diameter, will be installed
    Intervention: Procedure: Placement of extra short implants
  • Experimental: Standard group
    sinus floor elevation with will be performed using natural bovine bone graft as filler material and porcine dermis collagen membrane to cover the antrostomy. After 4 months of healing, one bone level implant, 10 mm long and 4.1 mm in diameter, will be installed into each augmented sinus.
    Interventions:
    • Procedure: maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation
    • Procedure: placement of standard implant
Publications *
  • Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x. Review.
  • Barone A, Ricci M, Grassi RF, Nannmark U, Quaranta A, Covani U. A 6-month histological analysis on maxillary sinus augmentation with and without use of collagen membranes over the osteotomy window: randomized clinical trial. Clin Oral Implants Res. 2013 Jan;24(1):1-6. doi: 10.1111/j.1600-0501.2011.02340.x. Epub 2011 Dec 12.
  • Masuda K, Silva ER, Botticelli D, Apaza Alccayhuaman KA, Xavier SP. Antrostomy Preparation for Maxillary Sinus Floor Augmentation Using Drills or a Sonic Instrument: A Microcomputed Tomography and Histomorphometric Study in Rabbits. Int J Oral Maxillofac Implants. 2019 July/August;34(4):819-827. doi: 10.11607/jomi.7350. Epub 2019 Feb 15.
  • Lundgren S, Andersson S, Gualini F, Sennerby L. Bone reformation with sinus membrane elevation: a new surgical technique for maxillary sinus floor augmentation. Clin Implant Dent Relat Res. 2004;6(3):165-73.
  • Cricchio G, Sennerby L, Lundgren S. Sinus bone formation and implant survival after sinus membrane elevation and implant placement: a 1- to 6-year follow-up study. Clin Oral Implants Res. 2011 Oct;22(10):1200-1212. doi: 10.1111/j.1600-0501.2010.02096.x.
  • Moon YS, Sohn DS, Moon JW, Lee JH, Park IS, Lee JK. Comparative histomorphometric analysis of maxillary sinus augmentation with absorbable collagen membrane and osteoinductive replaceable bony window in rabbits. Implant Dent. 2014 Feb;23(1):29-36. doi: 10.1097/ID.0000000000000031.
  • Omori Y, Ricardo Silva E, Botticelli D, Apaza Alccayhuaman KA, Lang NP, Xavier SP. Reposition of the bone plate over the antrostomy in maxillary sinus augmentation: A histomorphometric study in rabbits. Clin Oral Implants Res. 2018 Aug;29(8):821-834. doi: 10.1111/clr.13292. Epub 2018 Jun 7.
  • Corbella S, Taschieri S, Weinstein R, Del Fabbro M. Histomorphometric outcomes after lateral sinus floor elevation procedure: a systematic review of the literature and meta-analysis. Clin Oral Implants Res. 2016 Sep;27(9):1106-22. doi: 10.1111/clr.12702. Epub 2015 Oct 10. Review.
  • Caneva M, Lang NP, Garcia Rangel IJ, Ferreira S, Caneva M, De Santis E, Botticelli D. Sinus mucosa elevation using Bio-Oss(®) or Gingistat(®) collagen sponge: an experimental study in rabbits. Clin Oral Implants Res. 2017 Jul;28(7):e21-e30. doi: 10.1111/clr.12850. Epub 2016 Apr 15.
  • De Santis E, Lang NP, Ferreira S, Rangel Garcia I Jr, Caneva M, Botticelli D. Healing at implants installed concurrently to maxillary sinus floor elevation with Bio-Oss(®) or autologous bone grafts. A histo-morphometric study in rabbits. Clin Oral Implants Res. 2017 May;28(5):503-511. doi: 10.1111/clr.12825. Epub 2016 Mar 10.
  • Riachi F, Naaman N, Tabarani C, Aboelsaad N, Aboushelib MN, Berberi A, Salameh Z. Influence of material properties on rate of resorption of two bone graft materials after sinus lift using radiographic assessment. Int J Dent. 2012;2012:737262. doi: 10.1155/2012/737262. Epub 2012 Jul 31.
  • Shanbhag S, Shanbhag V, Stavropoulos A. Volume changes of maxillary sinus augmentations over time: a systematic review. Int J Oral Maxillofac Implants. 2014 Jul-Aug;29(4):881-92. doi: 10.11607/jomi.3472. Review.
  • Zijderveld SA, van den Bergh JP, Schulten EA, ten Bruggenkate CM. Anatomical and surgical findings and complications in 100 consecutive maxillary sinus floor elevation procedures. J Oral Maxillofac Surg. 2008 Jul;66(7):1426-38. doi: 10.1016/j.joms.2008.01.027.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2019) 		20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2, 2019
Actual Primary Completion Date December 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Edentulous maxilla
  • Willing to receive a full arch fixed restoration in the maxilla.
  • Latest extraction at least 8 weeks before implant insertion
  • Sinus floor height included between 4 to 6 mm
  • Bone width in the distal segments sufficient to allow the insertion of a 4 mm long implant of standard diameter.
  • In the anterior maxilla (from first premolar to first premolar) bone width sufficient to allow the insertion of 10 mm long implants of standard diameter. Minor horizontal augmentations with guided bone regeneration procedures was allowed in the anterior maxilla.

the opposing arch have to present one of the following conditions:

  • natural dentition (at least 10 elements from 3.5 to 4.5)
  • Fixed dental prosthesis of at least 10 elements (from 3.5 to 4.5) supported by teeth or implants
  • Implant supported or teeth supported overdentures
  • Adequate partial removable prostheses.

Exclusion Criteria:

  • Presence of conditions requiring prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements).
  • Major systemic diseases, or medical conditions requiring prolonged use of steroids, or alcoholism or chronically drug abuse.
  • Current pregnancy or breastfeeding women
  • Smokers > 10 cigarettes per day
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Immunocompromised patients including patients infected with HIV
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
  • Patients with an ongoing or previous treatment with bisphosphonates (for at least 2 months for oral therapy or 6 months for IV injection)

Local exclusion criteria

  • Local inflammation, including untreated periodontitis
  • Pre-cancerous oral lesions
  • History of local irradiation therapy
  • Severe bruxism or clenching habits
  • Patients with inadequate oral hygiene or unmotivated for adequate oral home care
  • Previous Guided bone regeneration or Guided tissue regeneration treatment at the implant site
  • Total removable prosthesis in the lower arch
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Gender identity
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958448
Other Study ID Numbers  ICMJE protocol #15052
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ARDEC Academy
Study Sponsor  ICMJE ARDEC Academy
Collaborators  ICMJE
  • University of Bologna
  • ITI International Team for Implantology, Switzerland
Investigators  ICMJE Not Provided
PRS Account ARDEC Academy
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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