NCT00868777

Brief Summary

The hypothesis of this study is that there is a significant difference in bone maturation after sinus grafting determined by the distance from the buccal to the palatal wall of this cavity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2008

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

Study Start

First participant enrolled

January 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
Last Updated

September 25, 2009

Status Verified

March 1, 2009

Enrollment Period

1.1 years

First QC Date

March 24, 2009

Last Update Submit

September 24, 2009

Conditions

EdentulismAlveolar Bone AtrophySinus Pneumatization

Keywords

Implant site developmentBone graftingDental implants

Outcome Measures

Primary Outcomes (1)

  • Histomorphometric proportion of vital bone

    Six months after sinus bone grafting, after harvesting a bone core biopsy at the time of implant placement

Study Arms (1)

Sinus grafting using allogenic bone

EXPERIMENTAL
Procedure: Sinus grafting using allogenic bone

Interventions

Sinus grafting using allogenic bonePROCEDURE

Surgical bone grafting procedure oriented to provide enough bone volume in atrophic posterior maxillary segments, when placement of endosteal implants is planned in order to restore missing teeth.

Also known as: Mineross - Human allograft
Sinus grafting using allogenic bone

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults patients (Older than 18 years), up to 85 years-old.
  • Physical status according to the American Society of Anesthesiologists (ASA) I or II
  • Patient in need of a sinus grafting using the lateral approach to allow the proper placement of dental implants. The remaining bone height must be 3 mm or less.
  • No uncontrolled systemic disease or condition known to alter bone metabolism
  • Adequate oral hygiene (O'Leary plaque score ≤20%)

You may not qualify if:

  • Long term (\>2 weeks) use of antibiotics in the past 3 months
  • Patients smoking more than half-pack a day
  • Patients taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, etc…)
  • Pregnant or attempting to get pregnant
  • Patients that don't meet the indications for sinus grafting (Existing sinus conditions, sepsis, history of cancer and/or radiation to the oral cavity, use of biphosphonates, pregnancy), or have postoperative complications related to those conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate Periodontics Clinic. School of Dentistry. University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

  • Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Mesa F, O'Valle-Ravassa F, Wang HL. Clinical and histologic comparison of two different composite grafts for sinus augmentation: a pilot clinical trial. Clin Oral Implants Res. 2008 Aug;19(8):755-9. doi: 10.1111/j.1600-0501.2008.01536.x.

    PMID: 18573123BACKGROUND

  • Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12.

    PMID: 17355356BACKGROUND

  • Gosau M, Rink D, Driemel O, Draenert FG. Maxillary sinus anatomy: a cadaveric study with clinical implications. Anat Rec (Hoboken). 2009 Mar;292(3):352-4. doi: 10.1002/ar.20859.

    PMID: 19248167BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 25, 2009

Study Start

January 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

September 25, 2009

Record last verified: 2009-03

Locations

US(1)