Hyaluronic Matrix Efficacy for Maxillary Sinus Augmentation

Sinus; Dental Clinical Trial

Official title:

Evaluation of Hyaluronic Matrix, Used With Xenograft, Efficacy in Sinus Augmentation by Histomorphometry and Micro Computed Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692261
• Other study ID #: KA-14030
• Status: Completed
• Phase: N/A
• First received: February 17, 2016
• Last updated: February 22, 2016
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Sinus augmentation is a predictable method when alveolar bone height is not sufficient for dental implant placement in posterior maxillary alveolar region..The aim of this prospective, randomized, controlled clinical study is comparison of hyaluronic acid originated matrix and equine derived xenograft with only xenograft use in sinus augmentation by micro computed tomography and histomorphometry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 33 Years to 69 Years

Eligibility

Inclusion Criteria:

• Systemically healthy patients

• Requiring bilateral maxillary sinus augmentation (residual crest height = 4 mm)

Exclusion Criteria:

• Advanced systemic diseases

• Chronic medication use

• Maxillary sinus disease

• Current pregnancy

• Lactation

• Smoking habit

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sinus; Dental

Intervention

Procedure:
• Maxillary Sinus Augmentation
Each 0.5 cc Collagenated Heterolog Bone Graft, mixed with two bundles of Hyaloss?? matrix and a few drops of sterile saline solution
• Maxillary Sinus Augmentation
Control group sinuses filled with heterolog bone graft alone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of newly formed bone calculated from bone biopsises by Micro-CT and Histomorphometry	Biological parameter obtained by analyzing bone biopsises	4 months after surgery	Yes

External Links

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