Sinus; DentalNCT02692261
Hyaluronic Matrix Efficacy for Maxillary Sinus Augmentation
A study testing Maxillary Sinus Augmentation in people with Sinus; Dental, run by Hacettepe University.
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… Read more about this study
- Who is it for?
- Ages 33 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus; Dental
- What is being tested?
- Maxillary Sinus Augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy patients
- Requiring bilateral maxillary sinus augmentation (residual crest height ≤ 4 mm)
Who cannot join
- Advanced systemic diseases
- Chronic medication use
- Maxillary sinus disease
- Current pregnancy
- Lactation
- Smoking habit
About this study
Official title: 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.
- Conditions
- Sinus; Dental
- Being tested
- Maxillary Sinus Augmentation
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary Sinus AugmentationProcedure or surgery
Also called Hyaloss matrix
Each 0.5 cc Collagenated Heterolog Bone Graft, mixed with two bundles of Hyalossᵀᴹ matrix and a few drops of sterile saline solution
Maxillary Sinus AugmentationProcedure or surgery
Control group sinuses filled with heterolog bone graft alone
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Maxillary Sinus Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of newly formed bone calculated from bone biopsises by Micro-CT and Histomorphometry
Biological parameter obtained by analyzing bone biopsises
Measured: 4 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus; DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EZGİ DOĞAN, Hacettepe University
- Investigators
- Feriha Caglayan, Professor, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692261
- Sponsor's protocol ID
- KA-14030
- Status last verified
- Feb 2016
- First submitted
- 17 Feb 2016
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hyaluronic Matrix, Used With Xenograft, Efficacy in Sinus Augmentation by Histomorphometry and Micro Computed Tomography
- ClinicalTrials.gov ID
- NCT02692261
- Acronym / sponsor ID
- KA-14030
- Conditions
- Sinus; Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyalossᵀᴹ matrix | Active comparator | Procedure: Maxillary Sinus AugmentationEach 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 |
| Apatos alone xenograft | Active comparator | Procedure: Maxillary Sinus AugmentationEach sinus was filled with 1 gr xenograft (with or without Hyaluronic Acide) for maxillary sinus augmentation |
Who may qualify
- Ages
- 33 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Systemically healthy patients
- Requiring bilateral maxillary sinus augmentation (residual crest height ≤ 4 mm)
Key exclusion criteria (6 listed)
- Advanced systemic diseases
- Chronic medication use
- Maxillary sinus disease
- Current pregnancy
- Lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxillary Sinus AugmentationAlso: Hyaloss matrixEach 0.5 cc Collagenated Heterolog Bone Graft, mixed with two bundles of Hyalossᵀᴹ matrix and a few drops of sterile saline solution | Procedure or surgery | Apatos alone xenograft, Hyalossᵀᴹ matrix |
| Maxillary Sinus AugmentationControl group sinuses filled with heterolog bone graft alone | Procedure or surgery | Apatos alone xenograft, Hyalossᵀᴹ matrix |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Individual participant dataSharing planned: No
Related trials for Sinus; Dental
Recruiting
Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide
Vertical Bone Defects, Missing Tooth/Teeth
Not yet recruitingEarly Phase 1
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin
Partially Edentulous Maxilla
Recruiting
Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
Severely Atrophic Posterior Maxilla
Recruiting
Using Chin Bone Rings for Sinus Lifting and Dental Implants in One Surgery
Maxillary Deficiency, Bone Resorption
Enrolling by invitation
Closed Sinus Augmentation With a Calcium Phosphosilicate Putty
Dental Implant, Maxillary Sinus Floor Augmentation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feriha Caglayan, Professor study chair
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary Sinus Augmentation in people with Sinus; Dental, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of newly formed bone calculated from bone biopsises by Micro-CT and Histomorphometry (time frame: 4 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.