Comparative Study of Algipore and Decalcified Freeze-dried Bone Allograft in Open Maxillary Sinus Augmentation

NCT ID: NCT01735721

Last Updated: 2015-04-08

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

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-06-30

Brief Summary

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The aim of this study was the radiographic and clinical comparison of Algipore with decalcified freeze-dried bone allograft (DFDBA) in the open maxillary sinus lift technique using piezoelectric instruments.

Detailed Description

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Vertical and horizontal bone resorption of the alveolar ridge are common in edentulous jaws. In the distal area of the maxilla, an adequate bone volume is often lacking because of the proximity of the sinus cavities to crestal bone. Sinus floor augmentation is an established way of increasing the height and volume of bone in the posterior region of the maxilla, which increase the stability of dental implants. For this purpose various materials, including auto grafts, allografts, alloplasts, and xenografts have been used.

Conditions

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Disorder of Maxillary Sinus Maxillary Sinus Floor Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Open Sinus Lift with DFDBA

In each patient, one sinus was chosen at random and filled with DFDBA (Tissue Regeneration Corporation, Iran).

Group Type ACTIVE_COMPARATOR

Open Sinus Lift

Intervention Type PROCEDURE

A crestal incision was made on the mucosa of the edentulous ridge. The flap was elevated carefully and extended labially to expose the bone. A vertical releasing incision was made in the mesial end of the flap as needed. The mucoperiosteal flap was extended to expose the alveolar ridge and the lateral wall of the maxillary sinus. Then, a window was prepared using the piezoelectric device (Mectron, Italy); the Schneiderian membrane was then elevated conservatively according to the technique described by Vercellotti (2001).

The sinus membrane was meticulously detached and pushed superiorly to allow for the placement of bone graft material.

Open Sinus Lift with Algipore

The contra lateral sinus was filled with Algipore (Dentsply, USA).

Group Type EXPERIMENTAL

Open Sinus Lift

Intervention Type PROCEDURE

A crestal incision was made on the mucosa of the edentulous ridge. The flap was elevated carefully and extended labially to expose the bone. A vertical releasing incision was made in the mesial end of the flap as needed. The mucoperiosteal flap was extended to expose the alveolar ridge and the lateral wall of the maxillary sinus. Then, a window was prepared using the piezoelectric device (Mectron, Italy); the Schneiderian membrane was then elevated conservatively according to the technique described by Vercellotti (2001).

The sinus membrane was meticulously detached and pushed superiorly to allow for the placement of bone graft material.

Interventions

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Open Sinus Lift

A crestal incision was made on the mucosa of the edentulous ridge. The flap was elevated carefully and extended labially to expose the bone. A vertical releasing incision was made in the mesial end of the flap as needed. The mucoperiosteal flap was extended to expose the alveolar ridge and the lateral wall of the maxillary sinus. Then, a window was prepared using the piezoelectric device (Mectron, Italy); the Schneiderian membrane was then elevated conservatively according to the technique described by Vercellotti (2001).

The sinus membrane was meticulously detached and pushed superiorly to allow for the placement of bone graft material.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* physically healthy patients
* ridge bone height of less than 5 mm

Exclusion Criteria

* any past medical history of systemic or localized diseases that were contraindications for sinus or implant surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amir Moeintaghavi

Professor of Periodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amir Moeintaghavi, DDS., Msc.

Role: STUDY_DIRECTOR

Mashhad University of Medical Sciences

Locations

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Amir Moeintaghavi

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

Other Identifiers

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86319

Identifier Type: -

Identifier Source: org_study_id

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