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

NCT01735721 | Completed Phase 2 DMC

• 1 other identifier: 86319
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Maxillary Sinus; Maxillary Sinus Floor Augmentation

Keywords

Sinus Floor Augmentation; Bone Transplantation; Bone Substitute

Outcome Measures

Primary Outcomes (1)

• increase in bone height

  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.

  9 months

Secondary Outcomes (1)

• Bone Density

  9 months

Study Arms (2)

Open Sinus Lift with DFDBA

ACTIVE COMPARATOR

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

Procedure: Open Sinus Lift

Open Sinus Lift with Algipore

EXPERIMENTAL

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

Procedure: Open Sinus Lift

Interventions

Open Sinus Lift 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; Open Sinus Lift with DFDBA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Amir Moeintaghavi

Mashhad, Khorasan Razavi, 91735-984, Iran

Location

Study Officials

• Amir Moeintaghavi, DDS., Msc.

  Mashhad University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Periodontics

Study Record Dates

• First Submitted: November 25, 2012
• First Posted: November 28, 2012
• Study Start: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

IR (1)