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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01735721
Enrollment
10
Registered
2012-11-28
Start date
2009-03-31
Completion date
2010-06-30
Last updated
2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Maxillary Sinus, Maxillary Sinus Floor Augmentation

Keywords

Sinus Floor Augmentation, Bone Transplantation, Bone Substitute

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.

Interventions

PROCEDUREOpen 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.

Sponsors

Mashhad University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
increase in bone height9 monthsBaseline 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

MeasureTime frameDescription
Bone Density9 monthsChanges in radiographic density after sinus grafting were evaluated using densitometry.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026