NCT02692261

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

February 17, 2016

Last Update Submit

February 22, 2016

Conditions

Sinus; Dental

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Hyalossᵀᴹ matrix

ACTIVE COMPARATOR

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

Apatos alone xenograft

ACTIVE COMPARATOR

Each sinus was filled with 1 gr xenograft (with or without Hyaluronic Acide) for maxillary sinus augmentation

Procedure: Maxillary Sinus Augmentation

Interventions

Maxillary Sinus AugmentationPROCEDURE

Each 0.5 cc Collagenated Heterolog Bone Graft, mixed with two bundles of Hyalossᵀᴹ matrix and a few drops of sterile saline solution

Also known as: Hyaloss matrix
Apatos alone xenograftHyalossᵀᴹ matrix

Eligibility Criteria

Age33 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systemically healthy patients
  • Requiring bilateral maxillary sinus augmentation (residual crest height ≤ 4 mm)

You may not qualify if:

  • Advanced systemic diseases
  • Chronic medication use
  • Maxillary sinus disease
  • Current pregnancy
  • Lactation
  • Smoking habit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fistula

Interventions

Sinus Floor Augmentation

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeBone TransplantationOrthopedic ProceduresDentistry

Study Officials

  • Feriha Caglayan, Professor

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 26, 2016

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share