Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone

Not Applicable

Completed

• Conditions: Maxillary Sinus
• Interventions: Procedure: Sinus lift; Procedure: Surgical alveolus; Procedure: Inorganic bovine bone; Procedure: Inorganic bovine bone + newly forming bone; Device: Collagen membrane

• Registration Number: NCT03419338
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2010-03-01
• Primary Completion: 2013-06-01
• Study Completion: 2013-06-30
• Study First Submitted: 2017-10-19
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-25
• Last Update Submitted: 2018-01-25
• Study First Posted: 2018-02-01
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Sinus lift	Surgical alveolus + maxillary sinus lift with inorganic bovine bone + newly forming bone + collagen membrane
Test group	Inorganic bovine bone + newly forming bone	Surgical alveolus + maxillary sinus lift with inorganic bovine bone + newly forming bone + collagen membrane
Control group	Sinus lift	Maxillary sinus lift with inorganic bovine bone + collagen membrane
Test group	Collagen membrane	Surgical alveolus + maxillary sinus lift with inorganic bovine bone + newly forming bone + collagen membrane
Test group	Surgical alveolus	Surgical alveolus + maxillary sinus lift with inorganic bovine bone + newly forming bone + collagen membrane
Control group	Inorganic bovine bone	Maxillary sinus lift with inorganic bovine bone + collagen membrane
Control group	Collagen membrane	Maxillary sinus lift with inorganic bovine bone + collagen membrane

Primary Outcome Measures

Name	Time	Method
Bone height measured in millimeters using the panoramic radiography reconstructions	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 Outcome Measures

Name	Time	Method
Descriptive histologic analysis of biopsy samples performed by two trained and previously calibrated examiners	Six months	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.
Quantitative histologic analysis of biopsy samples using Leahy et al. (2013) score	Six months	Quantification of the reactional and reparative phenomena related to cellular and tissue organization on biopsed samples were made using Leahy et al. (2013) score.
Histomorfometric analysis of biopsy samples using percentage of different tissues evaluated at ImageJ	Six months	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.

Trial Locations

Locations (1)

Bauru School of Dentistry - University of Sao Paulo; 🇧🇷 Bauru, SP, Brazil