Sinus LiftingNCT06135077
Titanium Prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation
A study testing T-PRF alone and T-PRF/Xenograft in people with Sinus Lifting, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
This trial aims to evaluate the effect of the sole use of T-PRF in bone formation process as applied in maxillary sinus floor elevation in comparison to traditional T-PRF/bone graft combination. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Sinus Lifting
- What is being tested?
- T-PRF alone and T-PRF/Xenograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2021to 21 Mar 2023
- 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 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Systemically in a healthy condition.
- Residual bone height is ≤5mm in the posterior maxilla as measured with CBCT.
- Non-smokers.
- Good oral hygiene as indicated by plaque and bleeding scores
Who cannot join
- Medically compromised conditions will be excluded to avoid infections or any adverse reaction related to immunity suppression.
- Acute maxillary sinusitis.
- Patients administering any antibiotics or regular anti-inflammatory drugs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
About this study
Official title: Evaluation of Titanium-prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation (Clinical Trial)
This trial aims to evaluate the effect of the sole use of T-PRF in bone formation process as applied in maxillary sinus floor elevation in comparison to traditional T-PRF/bone graft combination.
This study is clinical trial that will include 18 patients seeking implant placement in upper posterior maxilla compromised with maxillary sinus pneumatization. Patients will be assigned into control and test groups. All the patients will undergo sinus lifting procedure through which a combination of xenograft and T-PRF was used in the control group whereas; sole T-PRF will be applied in the test group.
- Conditions
- Sinus Lifting
- Being tested
- T-PRF alone, T-PRF/Xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-PRF aloneOther
T-PRF is the material to be tested in this study as an alternative to classical bone graft
T-PRF/XenograftOther
One part of T-PRF will be divided into minute pieces to be mixed with xenograft
| Study group | Role | What they receive |
|---|---|---|
| T-PRF | Experimental | Not described Receives: Other: T-PRF alone |
| T-PRF/xenograft | Active comparator | Not described Receives: Other: T-PRF/Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain level
measuring level of pain using visual analog scale (VAS) 0-10, where 0 reading indicates no pain and 10 reading reflects the most severe pain.
Measured: up to 2 weeks
Change in bone volume
pre opertaive and post operative CBCT
Measured: up to 3 months
Change in bone denisty
pre opertaive and post operative CBCT
Measured: up to 3 months
Change in bone height
pre opertaive and post operative CBCT
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start11 Nov 2021
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus LiftingStudies 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
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135077
- Sponsor's protocol ID
- 0301_10/2021
- Status last verified
- Nov 2023
- First submitted
- 11 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Titanium-prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation (Clinical Trial)
- ClinicalTrials.gov ID
- NCT06135077
- Acronym / sponsor ID
- 0301_10/2021
- Conditions
- Sinus Lifting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 18 Nov 2023 (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 trial aims to evaluate the effect of the sole use of T-PRF in bone formation process as applied in maxillary sinus floor elevation in comparison to traditional T-PRF/bone graft combination.
This study is clinical trial that will include 18 patients seeking implant placement in upper posterior maxilla compromised with maxillary sinus pneumatization. Patients will be assigned into control and test groups. All the patients will undergo sinus lifting procedure through which a combination of xenograft and T-PRF was used in the control group whereas; sole T-PRF will be applied in the test group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-PRF | Experimental | Other: T-PRF alone |
| T-PRF/xenograft | Active comparator | Other: T-PRF/Xenograft |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Systemically in a healthy condition.
- Residual bone height is ≤5mm in the posterior maxilla as measured with CBCT.
- Non-smokers.
- Good oral hygiene as indicated by plaque and bleeding scores
Key exclusion criteria (3 listed)
- Medically compromised conditions will be excluded to avoid infections or any adverse reaction related to immunity suppression.
- Acute maxillary sinusitis.
- Patients administering any antibiotics or regular anti-inflammatory drugs.
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 |
|---|---|---|
| T-PRF aloneT-PRF is the material to be tested in this study as an alternative to classical bone graft | Other | T-PRF |
| T-PRF/XenograftOne part of T-PRF will be divided into minute pieces to be mixed with xenograft | Other | T-PRF/xenograft |
Primary outcome
Change in pain level
Time frame: up to 2 weeks
measuring level of pain using visual analog scale (VAS) 0-10, where 0 reading indicates no pain and 10 reading reflects the most severe pain.
Change in bone volume
Time frame: up to 3 months
pre opertaive and post operative CBCT
Change in bone denisty
Time frame: up to 3 months
pre opertaive and post operative CBCT
Change in bone height
Time frame: up to 3 months
pre opertaive and post operative CBCT
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 18 Nov 2023.
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Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide
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Endoscopic-Assisted Versus Conventional Crestal Sinus Lift
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Severely Atrophic Posterior Maxilla
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-PRF alone and T-PRF/Xenograft in people with Sinus Lifting, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 4 inclusion and 3 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in pain level (time frame: up to 2 weeks). The study lists 4 primary outcomes in all. 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 18 Nov 2023.