Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone

Maxillary Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419338
• Other study ID #: FOBGranSinus
• Status: Completed
• Phase: N/A
• First received: October 19, 2017
• Last updated: January 25, 2018
• Start date: March 1, 2010
• Est. completion date: June 30, 2013

Study information

• Verified date: January 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 30, 2013
• Est. primary completion date: June 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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)

• Pregnant

• Smokers

• Diabetics

• History of head and neck radiotherapy

Related Conditions & MeSH terms

• Maxillary Sinus

Intervention

Procedure:
• Sinus lift
Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material.
• Surgical alveolus
Using a round diamond bur, a surgical alveolus will be created on an toothless ridge region.
• Inorganic bovine bone + newly forming bone
Maxillary sinus lift will be done with inorganic bovine bone associated with newly forming bone. The newly forming bone will be collected from surgical alveolus previous prepared.
• Inorganic bovine bone
Maxillary sinus lift will be done with inorganic bovine bone.

Device:
• Collagen membrane
At the end of the sinus lift, a collagen membrane will be used to obliterate the graft inside the maxillary sinus.

Locations

Country	Name	City	State
Brazil	Bauru School of Dentistry - University of Sao Paulo	Bauru	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone height measured in millimeters using the panoramic radiography reconstructions	It will be measured the distance between the alveolar ridge and the maxillary sinus in panoramic radiography reconstructions taken before and after sinus lift.	Six months
Secondary	Descriptive histologic analysis of biopsy samples performed by two trained and previously calibrated examiners	On the surface and around the particles of the materials with the newformed reactive tissue, it was analyzed the presence and absence of the following tissue and reactive cellular elements: granulation tissue, newly formed blood vessels, fibroblasts, osteoblasts and mineralized bone matrix, foreign body type granuloma, macrophages, inflammatory multinucleated giant cells.	Six months
Secondary	Quantitative histologic analysis of biopsy samples using Leahy et al. (2013) score	Quantification of the reactional and reparative phenomena related to cellular and tissue organization on biopsed samples were made using Leahy et al. (2013) score.	Six months
Secondary	Histomorfometric analysis of biopsy samples using percentage of different tissues evaluated at ImageJ	The tissue sections were captured with 4x and 10x objective and images were recorded and later analyzed in the ImageJ software. The proportions of vital bone, cortical bone, medullary bone, remnant non-vital particles and connective tissue were quantified separately and expressed as percentages.	Six months