NCT01942304

Brief Summary

The purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS putty bone substitute in posterior maxillary sites and the survival of implants placed in these sites following healing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

4.3 years

First QC Date

September 10, 2013

Last Update Submit

October 30, 2019

Conditions

Sinus Floor AugmentationMaxillary Sinus

Keywords

Sinus Floor AugmentationMaxillary SinusBone SubstitutesBone Regeneration

Outcome Measures

Primary Outcomes (1)

  • Percentage of new bone growth in the maxillary sinus

    Difference between the percentage of new bone growth between the two groups as determined by histomorphometric analysis of bone cores retrieved during implant placement surgery.

    7 months(plus minus 1 month)

Secondary Outcomes (4)

  • Gain in vertical bone height

    6 months (plus or minus 1month)

  • Radiographic bone density

    6 months (plus or minus 1 month)

  • Primary implant stability

    7 months (plus or minus 1 month)

  • Marginal bone level maintenance

    12 months(plus or minus 1 month)

Other Outcomes (1)

  • Implant success

    2nd stage, 6&12 months post-loading

Study Arms (2)

Anorganic bovine bone mineral in direct sinus augmentation

ACTIVE COMPARATOR

Anorganic bovine bone mineral

Procedure: Anorganic bovine bone mineral in direct sinus augmentation

Alloplastic bone putty in direct sinus augmentation

EXPERIMENTAL

Alloplastic bone putty

Procedure: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation

Interventions

Calcium phosphosilicate alloplastic bone putty in direct sinus augmentationPROCEDURE
Alloplastic bone putty in direct sinus augmentation
Anorganic bovine bone mineral in direct sinus augmentationPROCEDURE
Anorganic bovine bone mineral in direct sinus augmentation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with non-contributory medical history that will present for bilateral sinus lift surgery prior to implant placement

You may not qualify if:

  • Patients that will not agree to participate in this study or sign the consent form
  • More than 8mm of residual bone height at the implant site
  • Subjects smoking more than 10 cigarettes per day
  • History of acute sinus infection
  • History of prior maxillary sinus surgery (Caldwell-Luc, direct or indirect sinus lift, etc)
  • Medications that affect bone healing (chronic steroid regimen, oral or IV bisphosphonates, etc.)
  • Patients allergic to bovine derivatives
  • Patients who are a carrier of transmissible disease(s) that may unnecessarily expose laboratory personnel to risks
  • Females during pregnancy or lactation or females that plan to become pregnant in the following year (pregnancy test prior to enrollment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Education in Periodontology Clinic, Dental School, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (3)

  • Hallman M, Sennerby L, Lundgren S. A clinical and histologic evaluation of implant integration in the posterior maxilla after sinus floor augmentation with autogenous bone, bovine hydroxyapatite, or a 20:80 mixture. Int J Oral Maxillofac Implants. 2002 Sep-Oct;17(5):635-43.

    PMID: 12381063BACKGROUND

  • Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.

    PMID: 15626319BACKGROUND

  • Mahesh L, Venkataraman N, Shukla S, Prasad H, Kotsakis GA. Alveolar ridge preservation with the socket-plug technique utilizing an alloplastic putty bone substitute or a particulate xenograft: a histological pilot study. J Oral Implantol. 2015 Apr;41(2):178-83. doi: 10.1563/AAID-JOI-D-13-00025. Epub 2013 Jun 17.

    PMID: 23772806BACKGROUND

Study Officials

  • Georgios A Kotsakis, DDS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • James E Hinrichs, DDS, MS

    University of Minnesota

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2018

Study Completion

May 31, 2019

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

US(1)