Hyaluronic Matrix Efficacy for Maxillary Sinus Augmentation

February 22, 2016 updated by: EZGİ DOĞAN, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hyalossᵀᴹ matrix
Each 0.5 cc Collagenated Heterolog Bone Graft, mixed with two bundles of Hyalossᵀᴹ matrix and a few drops of sterile saline solution used for maxillary sinus augmentation
Procedure: Maxillary Sinus Augmentation
Each 0.5 cc Collagenated Heterolog Bone Graft, mixed with two bundles of Hyalossᵀᴹ matrix and a few drops of sterile saline solution
Other Names:
  • Hyaloss matrix
Procedure: Maxillary Sinus Augmentation
Control group sinuses filled with heterolog bone graft alone
ACTIVE_COMPARATOR: Apatos alone xenograft
Each sinus was filled with 1 gr xenograft (with or without Hyaluronic Acide) for maxillary sinus augmentation
Procedure: Maxillary Sinus Augmentation
Each 0.5 cc Collagenated Heterolog Bone Graft, mixed with two bundles of Hyalossᵀᴹ matrix and a few drops of sterile saline solution
Other Names:
  • Hyaloss matrix
Procedure: Maxillary Sinus Augmentation
Control group sinuses filled with heterolog bone graft alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of newly formed bone calculated from bone biopsises by Micro-CT and Histomorphometry
Time Frame: 4 months after surgery
Biological parameter obtained by analyzing bone biopsises
4 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Chair: Feriha Caglayan, Professor, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (ESTIMATE)

February 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • KA-14030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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