Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-01

Study Completion Date

2013-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Maxillary Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Test group

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

Group Type EXPERIMENTAL

Sinus lift

Intervention Type PROCEDURE

Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material.

Surgical alveolus

Intervention Type PROCEDURE

Using a round diamond bur, a surgical alveolus will be created on an toothless ridge region.

Inorganic bovine bone + newly forming bone

Intervention Type PROCEDURE

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.

Collagen membrane

Intervention Type DEVICE

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

Control group

Maxillary sinus lift with inorganic bovine bone + collagen membrane

Group Type ACTIVE_COMPARATOR

Sinus lift

Intervention Type PROCEDURE

Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material.

Inorganic bovine bone

Intervention Type PROCEDURE

Maxillary sinus lift will be done with inorganic bovine bone.

Collagen membrane

Intervention Type DEVICE

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

Interventions

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Sinus lift

Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material.

Intervention Type PROCEDURE

Surgical alveolus

Using a round diamond bur, a surgical alveolus will be created on an toothless ridge region.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Inorganic bovine bone

Maxillary sinus lift will be done with inorganic bovine bone.

Intervention Type PROCEDURE

Collagen membrane

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes