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Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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