NCT03419338

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2013

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

3.3 years

First QC Date

October 19, 2017

Last Update Submit

January 25, 2018

Conditions

Maxillary Sinus

Keywords

Maxillary SinusSinus liftingBone graft

Outcome Measures

Primary Outcomes (1)

  • Bone height measured in millimeters using the panoramic radiography reconstructions

    It will be measured the distance between the alveolar ridge and the maxillary sinus in panoramic radiography reconstructions taken before and after sinus lift.

    Six months

Secondary Outcomes (3)

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

    Six months

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

    Six months

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

    Six months

Study Arms (2)

Test group

EXPERIMENTAL

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

Procedure: Sinus liftProcedure: Surgical alveolusProcedure: Inorganic bovine bone + newly forming boneDevice: Collagen membrane

Control group

ACTIVE COMPARATOR

Maxillary sinus lift with inorganic bovine bone + collagen membrane

Procedure: Sinus liftProcedure: Inorganic bovine boneDevice: Collagen membrane

Interventions

Sinus liftPROCEDURE

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

Control groupTest group
Surgical alveolusPROCEDURE

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

Test group
Inorganic bovine bone + newly forming bonePROCEDURE

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.

Test group
Inorganic bovine bonePROCEDURE

Maxillary sinus lift will be done with inorganic bovine bone.

Control group
Collagen membraneDEVICE

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

Control groupTest group

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bauru School of Dentistry - University of Sao Paulo

Bauru, São Paulo, 17012-901, Brazil

Location

Study Officials

  • Adriana CP Sant'Ana, PhD

    Bauru School of Dentistry - University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 19, 2017

First Posted

February 1, 2018

Study Start

March 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 30, 2013

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

BR(1)