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.

NCT03958448 | Completed DMC

• 1 other identifier: protocol #15052
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (2)

• 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.

  24 months

• 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.

  24 months

Secondary Outcomes (1)

• Technical complications

  24 months

Study Arms (2)

Short Group

EXPERIMENTAL

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

Standard group

EXPERIMENTAL

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

Interventions

Placement of extra short implants PROCEDURE

placement of an extra short implant in the posterior edentulous ridge

Short Group

maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation PROCEDURE

Standard group

placement of standard implant PROCEDURE

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

Standard group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• ARDEC Academy: lead
• University of Bologna: collaborator
• ITI International Team for Implantology, Switzerland: collaborator

Related Publications (13)

• 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.

  PMID: 18724852 RESULT

• 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.

  PMID: 22151577 RESULT

• 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.

  PMID: 30768660 RESULT

• 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.

  PMID: 15726851 RESULT

• 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.

  PMID: 21906186 RESULT

• 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.

  PMID: 24445918 RESULT

• 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.

  PMID: 29876969 RESULT

• 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.

  PMID: 26452326 RESULT

• 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.

  PMID: 27080163 RESULT

• 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.

  PMID: 26969193 RESULT

• 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.

  PMID: 22899930 RESULT

• 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.

  PMID: 25032768 RESULT

• 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.

  PMID: 18571027 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 22, 2019
• Study Start: October 1, 2015
• Primary Completion: December 2, 2018
• Study Completion: April 2, 2019
• Last Updated: May 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share