Maxillary SinusNCT03096210
Titanium-Prepared Platelet Rich Fibrin in the Sinus Lifting Procedure
A study testing Titanium-Prepared Platelet Rich Fibrin and Allograft (CTBA Allograft) in people with Maxillary Sinus, run by Kırıkkale University.
Trial summary
This study evaluates the radiographic, histological and clinical comparisons of the completely autologous T-PRF or allograft effectiveness at the maxillary sinus elevation procedure. Read more about this study
- Who is it for?
- Ages 42 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus
- What is being tested?
- Titanium-Prepared Platelet Rich Fibrin and Allograft (CTBA Allograft)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2013to 2 Mar 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 42 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants having been diagnosed to display a residual crest height of less than 5mm in posterior maxilla and non-smokers were included.
Who cannot join
- Participants with blood platelet disorders, infectious and metabolic diseases, ongoing chemotherapy or radiotherapy, history of chronic sinusitis associated with maxillary sinuses, taking any antibiotics and/or anti-inflammatory drugs were excluded.
About this study
Official title: Comparison of the Clinic, Radiographic and Histological Effects of Allograft and T-PRF (Titanium-Prepared Platelet Rich Fibrin) Materials in the Sinus Lifting Procedure. Preliminary Results From a Pilot Randomised Controlled Trial
This study evaluates the radiographic, histological and clinical comparisons of the completely autologous T-PRF or allograft effectiveness at the maxillary sinus elevation procedure.
Read the detailed description
Participants randomly divided into 2 groups and the test group had a Schneiderian membrane elevation with using balloon lifting technique and after that sinus was filled with T-PRF produced from the patients' blood and 4 months waiting period has been entered. At the end of the 4th month, the bone samples were received from the implant slots and sent to histological evaluation. After 3 months, implant stability was measured and recorded. In the control group, the same procedures were followed and sinus was filled with only allograft. Waiting period was changed to 6 months for this group.
- Conditions
- Maxillary Sinus
- Being tested
- Titanium-Prepared Platelet Rich Fibrin, Allograft (CTBA Allograft)
- Keywords
- Maxillar sinus, Titanium-Prepared Platelet Rich Fibrin, Allograft, implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium-Prepared Platelet Rich FibrinOther
Blood samples were collected from the each participant's arm in the test group by 20 ml syringe and then was transferred into 10ml grade IV titanium tube without anticoagulant. After centrifugation of blood samples (2800 rpm, 12 minutes) at room temperature, the T-PRF clot was removed from the tubes with sterile tweezers. 6 blood tubes were collected for a sinus floor elevation/lifting operation and 6 T-PRFs were prepared for each participant.
Allograft (CTBA Allograft)Other
After careful elevation of the schneiderian membrane without perforation, allograft was only used for augmentation of the sinus floor in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Titanium-Prepared Platelet Rich Fibrin | Other | After careful elevation of the schneiderian membrane without perforation,T-PRFs were only used in the test group. Receives: Other: Titanium-Prepared Platelet Rich Fibrin |
| Allograft (CTBA Allograft) | Other | After careful elevation of the schneiderian membrane without perforation, allograft was only used for augmentation of the sinus floor in the control group. Receives: Other: Allograft (CTBA Allograft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Examination
Percentage (%) of new and old trabeculae formation post surgery
Measured: At the first 4 and 6th months post surgery for the test and control groups, respectively.
Secondary outcomes (2)
Radiological Examination
Density (hu) measurements
Measured: Within the first 4 and 6 months
Implant stability measurements
Implant Stability Quotient values (50-80 ISQ)
Measured: Within the 3 months after implant surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start11 Mar 2013
- Primary completion28 Nov 2014
- Study completion2 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary SinusStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Olgun Erdemir, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096210
- Sponsor's protocol ID
- 2013/05
- Status last verified
- Sep 2020
- First submitted
- 8 Mar 2017
- Last updated
- 4 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinic, Radiographic and Histological Effects of Allograft and T-PRF (Titanium-Prepared Platelet Rich Fibrin) Materials in the Sinus Lifting Procedure. Preliminary Results From a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03096210
- Acronym / sponsor ID
- 2013/05
- Conditions
- Maxillary Sinus
- Keywords
- Maxillar sinus, Titanium-Prepared Platelet Rich Fibrin, Allograft, implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 11 Mar 2013 (actual)
- Primary completion
- 28 Nov 2014 (actual)
- Study completion
- 2 Mar 2015 (actual)
- First posted
- 30 Mar 2017 (actual)
- 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.
This study evaluates the radiographic, histological and clinical comparisons of the completely autologous T-PRF or allograft effectiveness at the maxillary sinus elevation procedure.
Detailed description
Participants randomly divided into 2 groups and the test group had a Schneiderian membrane elevation with using balloon lifting technique and after that sinus was filled with T-PRF produced from the patients' blood and 4 months waiting period has been entered. At the end of the 4th month, the bone samples were received from the implant slots and sent to histological evaluation. After 3 months, implant stability was measured and recorded. In the control group, the same procedures were followed and sinus was filled with only allograft. Waiting period was changed to 6 months for this group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium-Prepared Platelet Rich Fibrin | Other | Other: Titanium-Prepared Platelet Rich FibrinAfter careful elevation of the schneiderian membrane without perforation,T-PRFs were only used in the test group. |
| Allograft (CTBA Allograft) | Other | Other: Allograft (CTBA Allograft)After careful elevation of the schneiderian membrane without perforation, allograft was only used for augmentation of the sinus floor in the control group. |
Who may qualify
- Ages
- 42 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants having been diagnosed to display a residual crest height of less than 5mm in posterior maxilla and non-smokers were included.
Key exclusion criteria (1 listed)
- Participants with blood platelet disorders, infectious and metabolic diseases, ongoing chemotherapy or radiotherapy, history of chronic sinusitis associated with maxillary sinuses, taking any antibiotics and/or anti-inflammatory drugs were excluded.
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 |
|---|---|---|
| Titanium-Prepared Platelet Rich FibrinBlood samples were collected from the each participant's arm in the test group by 20 ml syringe and then was transferred into 10ml grade IV titanium tube without anticoagulant. After centrifugation of blood samples (2800 rpm, 12 minutes) at room temperature, the T-PRF clot was removed from the tubes with sterile tweezers. 6 blood tubes were collected for a sinus floor elevation/lifting operation and 6 T-PRFs were prepared for each participant. | Other | Titanium-Prepared Platelet Rich Fibrin |
| Allograft (CTBA Allograft)After careful elevation of the schneiderian membrane without perforation, allograft was only used for augmentation of the sinus floor in the control group. | Other | Allograft (CTBA Allograft) |
Primary outcome
Histological Examination
Time frame: At the first 4 and 6th months post surgery for the test and control groups, respectively.
Percentage (%) of new and old trabeculae formation post surgery
2 secondary outcomes
Radiological Examination
Time frame: Within the first 4 and 6 months
Implant stability measurements
Time frame: Within the 3 months after implant surgery
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 4 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Maxillary Sinus
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Not yet recruiting
Buccal Periosteal Inversion Flap vs Buccal Advancement Flap for Acute Oro-Antral Communication Closure
Acute Oroantral Communication
Active, not recruitingPhase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm
Enrolling by invitationPhase 1
Smart Scaffolds, Stronger Smiles Smarter Healing: AI-Boosted Multiphasic Scaffold Design for PDL Regeneration
Regeneration of Alveolar Tissue After 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Titanium-Prepared Platelet Rich Fibrin and Allograft (CTBA Allograft) in people with Maxillary Sinus, run by Kırıkkale 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 1 inclusion and 1 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 4 Sep 2020. 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?
Histological Examination (time frame: At the first 4 and 6th months post surgery for the test and control groups, respectively.). 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 4 Sep 2020.