Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone

University of Sao Paulo

Status: Completed

Conditions: Maxillary Sinus

Treatments: Procedure: Sinus lift; Device: Collagen membrane; Procedure: Surgical alveolus; Procedure: Inorganic bovine bone; Procedure: Inorganic bovine bone + newly forming bone

Study type: Interventional

Funder types: Other

Identifiers

NCT03419338

FOBGranSinus

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Test group

Experimental group

Description:

Surgical alveolus + maxillary sinus lift with inorganic bovine bone + newly forming bone + collagen membrane

Treatment:

Device: Collagen membrane

Procedure: Surgical alveolus

Procedure: Sinus lift

Procedure: Inorganic bovine bone + newly forming bone

Control group

Active Comparator group

Description:

Maxillary sinus lift with inorganic bovine bone + collagen membrane

Treatment:

Device: Collagen membrane

Procedure: Sinus lift

Procedure: Inorganic bovine bone