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Clinical Trials/NCT01735721
NCT01735721CompletedPhase 2

Comparative Study of Algipore and Decalcified Freeze-dried Bone Allograft in Open Maxillary Sinus Elevation Using Piezoelectric Surgery

Mashhad University of Medical Sciences1 site in 1 country10 target enrollmentStarted: March 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
increase in bone height

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Open Sinus Lift with DFDBA

Active Comparator

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

Intervention: Open Sinus Lift (Procedure)

Open Sinus Lift with Algipore

Experimental

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

Intervention: Open Sinus Lift (Procedure)

Outcomes

Primary Outcomes

increase in bone height

Time Frame: 9 months

Baseline and 9 months radiographs were scanned with an Agfa scanner at 1200 dpi with a 12-bit grayscale and stored in JPEG format. Changes in bone height were calculated in each case. Two reference points, one at the lowest part of the ridge crest and the other at the highest part of sinus floor, were selected in two radiographs (baseline and after 9 months) and their distance was calculated in 0.1mm scale using computer.

Secondary Outcomes

  • Bone Density(9 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amir Moeintaghavi

Professor of Periodontics

Mashhad University of Medical Sciences

Study Sites (1)

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