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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amir Moeintaghavi, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01735721
First received: November 25, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Disorder of Maxillary Sinus
Procedure: Open Sinus Lift
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of Algipore and Decalcified Freeze-dried Bone Allograft in Open Maxillary Sinus Elevation Using Piezoelectric Surgery

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • increase in bone height [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Bone Density [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Changes in radiographic density after sinus grafting were evaluated using densitometry.


Enrollment: 10
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open Sinus Lift with DFDBA
In each patient, one sinus was chosen at random and filled with DFDBA (Tissue Regeneration Corporation, Iran).
Procedure: 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.

Experimental: Open Sinus Lift with Algipore
The contra lateral sinus was filled with Algipore (Dentsply, USA).
Procedure: 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.


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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735721

Locations
Iran, Islamic Republic of
Amir Moeintaghavi
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735-984
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Study Director: Amir Moeintaghavi, DDS., Msc. Mashhad University of Medical Sciences
  More Information

No publications provided

Responsible Party: Amir Moeintaghavi, Professor of Periodontics, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01735721     History of Changes
Other Study ID Numbers: 86319
Study First Received: November 25, 2012
Last Updated: November 25, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Mashhad University of Medical Sciences:
Sinus Floor Augmentation
Bone Transplantation
Bone Substitute

ClinicalTrials.gov processed this record on August 27, 2014