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

Phase 2

Completed

• Conditions: Maxillary Sinus Floor Augmentation; Disorder of Maxillary Sinus
• Interventions: Procedure: Open Sinus Lift

• Registration Number: NCT01735721
• Lead Sponsor: Mashhad University of Medical Sciences

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 Timeline

• Study Start: 2009-03
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2012-11-25
• Study First Submitted QC: 2012-11-25
• Study First Posted: 2012-11-28
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Open Sinus Lift with DFDBA	Open Sinus Lift	In each patient, one sinus was chosen at random and filled with DFDBA (Tissue Regeneration Corporation, Iran).
Open Sinus Lift with Algipore	Open Sinus Lift	The contra lateral sinus was filled with Algipore (Dentsply, USA).

Primary Outcome Measures

Name	Time	Method
increase in bone height	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 Outcome Measures

Name	Time	Method
Bone Density	9 months	Changes in radiographic density after sinus grafting were evaluated using densitometry.

Trial Locations

Locations (1)

Amir Moeintaghavi; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of