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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.

Primary Purpose

Alveolar Bone Loss

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Placement of extra short implants

maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation

placement of standard implant

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Short Group

Standard group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

survival rate of 4 mm implants used as distal support

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

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

Technical complications

Any technical complications related to implants, abutments, screw loosening, prosthetic fracture or chipping of the veneer material expressed in number of occurrence.

Full Information

NCT ID

NCT03958448

First Posted

May 15, 2019

Last Updated

May 21, 2019

Sponsor

ARDEC Academy

Collaborators

University of Bologna, ITI International Team for Implantology, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT03958448

Brief 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.

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

October 1, 2015 (Actual)

Primary Completion Date

December 2, 2018 (Actual)

Study Completion Date

April 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ARDEC Academy

Collaborators

University of Bologna, ITI International Team for Implantology, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alveolar Bone Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Care ProviderInvestigatorOutcomes 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

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Short Group

Arm Type

Experimental

Arm Description

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

Arm Title

Standard group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Placement of extra short implants

Intervention Description

placement of an extra short implant in the posterior edentulous ridge

Intervention Type

Procedure

Intervention Name(s)

maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation

Intervention Type

Procedure

Intervention Name(s)

placement of standard implant

Intervention Description

placement of standard implant in the posterior edentulous ridge after maxillary sinus augmentation

Primary Outcome Measure Information:

Title

survival rate of 4 mm implants used as distal support

Description

Time Frame

24 months

Title

Crestal bone level

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Technical complications

Description

Any technical complications related to implants, abutments, screw loosening, prosthetic fracture or chipping of the veneer material expressed in number of occurrence.

Time Frame

24 months

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Gender identity

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18724852

Citation

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.

Results Reference

result

PubMed Identifier

22151577

Citation

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.

Results Reference

result

PubMed Identifier

30768660

Citation

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.

Results Reference

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PubMed Identifier

15726851

Citation

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.

Results Reference

result

PubMed Identifier

21906186

Citation

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.

Results Reference

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PubMed Identifier

24445918

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

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Citation

Caneva M, Lang NP, Garcia Rangel IJ, Ferreira S, Caneva M, De Santis E, Botticelli D. Sinus mucosa elevation using Bio-Oss(R) or Gingistat(R) 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.

Results Reference

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PubMed Identifier

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Citation

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(R) 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.

Results Reference

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Citation

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.

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Citation

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.

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Citation

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.

Results Reference

result

Learn more about this trial

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.

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