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Clinical Trials/NCT03419338
NCT03419338
Completed
Not Applicable

Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone: a Clinical, Histologic and Histomorphometric Evaluation

University of Sao Paulo1 site in 1 country16 target enrollmentMarch 1, 2010
ConditionsMaxillary Sinus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maxillary Sinus
Sponsor
University of Sao Paulo
Enrollment
16
Locations
1
Primary Endpoint
Bone height measured in millimeters using the panoramic radiography reconstructions
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. For that, it will be compared the tomographic bone gain 6 months after surgery between a group that received inorganic bovine bone alone (n=8) and a group that received inorganic bovine bone associated with NFB (n=8).

Detailed Description

The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. It will be recruited for this study individuals 25-60 years of age, both genders, presenting a missing tooth at an upper premolar or molar region with 2-9 mm of remaining bone between alveolar ridge crest and sinus floor and the existence of an edentulous ridge or at least one tooth condemned to extraction. Sinus will be treated by NFB mixed to inorganic bovine bone - IBB (test; n= 8) or IBB (control; n= 8). The volume of bone tissue will be evaluated by computerized tomography obtained at baseline examination and 6 months after surgery. After this period, biopsies of hard tissue will be obtained during implant placement for histologic and histomorphometric analysis.

Registry
clinicaltrials.gov
Start Date
March 1, 2010
End Date
June 30, 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adriana Campos Passanezi SantAna

Associate Professor

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Presenting a distance between alveolar crest and maxillary sinus of 2 to 9 millimeters.

Exclusion Criteria

  • History of periodontal surgery at the area on the last 12 months
  • Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based, contraceptives, steroids)
  • Diabetics
  • History of head and neck radiotherapy

Outcomes

Primary Outcomes

Bone height measured in millimeters using the panoramic radiography reconstructions

Time Frame: Six months

It will be measured the distance between the alveolar ridge and the maxillary sinus in panoramic radiography reconstructions taken before and after sinus lift.

Secondary Outcomes

  • Descriptive histologic analysis of biopsy samples performed by two trained and previously calibrated examiners(Six months)
  • Quantitative histologic analysis of biopsy samples using Leahy et al. (2013) score(Six months)
  • Histomorfometric analysis of biopsy samples using percentage of different tissues evaluated at ImageJ(Six months)

Study Sites (1)

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