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NCT Number: NCT03419338

Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone

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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Key information

Conditions

Maxillary Sinus

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bauru School of Dentistry - University of Sao Paulo

Bauru, São Paulo, 17012-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sinus lift

Procedure

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

Surgical alveolus

Procedure

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

Inorganic bovine bone + newly forming bone

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.

Inorganic bovine bone

Procedure

Maxillary sinus lift will be done with inorganic bovine bone.

Collagen Membrane

Device

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

Primary outcomes

  1. Bone height measured in millimeters using the panoramic radiography reconstructions

    Time frame: 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 outcomes

  1. Descriptive histologic analysis of biopsy samples performed by two trained and previously calibrated examiners

    Time frame: 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.

  2. Quantitative histologic analysis of biopsy samples using Leahy et al. (2013) score

    Time frame: 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.

  3. Histomorfometric analysis of biopsy samples using percentage of different tissues evaluated at ImageJ

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 1, 2018
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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