Sinus Floor ElevationNCT05721612
Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach
A study testing Flapless transcrestal sinus lift approach with TPRF and Flapless transcrestal sinus lift approach with PRF in people with Sinus Floor Elevation, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence flapless transcrestal sinus floor elevation is minimally invasive technique which is used in… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Sinus Floor Elevation
- What is being tested?
- Flapless transcrestal sinus lift approach with TPRF and Flapless transcrestal sinus lift approach with PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 5 Feb 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient seeking replacement of a missed maxillary posterior teeth by a delayed dental implant procedure.
- Residual bone height is (4-7) mm measured from crestal bone to sinus floor.
- Good oral hygiene
Who cannot join
- Uncontrolled Diabetes.
- Coagulation disorders.
- Immunological disorders.
- Previous radiation of the head and neck region.
- Abnormal bone physiology.
- Therapy with Bisphosphonates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach ( a Randomized Controlled Clinical Trial)
Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence flapless transcrestal sinus floor elevation is minimally invasive technique which is used in moderately defected maxilla.
Aim of the study: to evaluate both clinical and radiographic outcomes in sinus floor elevation following dental implant placement using flapless transcrestal sinus lift approach with Titanium platelet rich fibrin (TPRF) as a sole sinus graft material compared to Platelet rich fibrin (PRF).
- Conditions
- Sinus Floor Elevation
- Being tested
- Flapless transcrestal sinus lift approach with TPRF, Flapless transcrestal sinus lift approach with PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flapless transcrestal sinus lift approach with TPRFOther
Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the TPRF as a sole grafting material.
Flapless transcrestal sinus lift approach with PRFOther
Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the PRF as a sole grafting material.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Other: Flapless transcrestal sinus lift approach with TPRF |
| Control gorup | Active comparator | Not described Receives: Other: Flapless transcrestal sinus lift approach with PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone density
Cuts of CBCT (cross sectional, axial and sagittal view), bone density, will be analyzed using On-demand software. The radiographic evaluation will be based on radiological parameters, using reference points and lines at T0 and T1.
Measured: Baseline and 6 months
Secondary outcomes (2)
Change in implant stability
Secondary implant stability will be measured 6 months post-operatively using Osstell device.
Measured: Baseline and 6 months
change in pain scores
Pain (by Visual Analogous Scale) ranges from 0 to 10 0 - No pain. 2 to 4 - Mild pain. 5 to 7 - Moderate pain. 8 to 10 - severe pain.
Measured: 1st day, 3rd day and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start15 Mar 2022
- Primary completion30 Jan 2023
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Floor ElevationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 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
- NCT05721612
- Sponsor's protocol ID
- TPRF_2021
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 21 Feb 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach ( a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05721612
- Acronym / sponsor ID
- TPRF_2021
- Conditions
- Sinus Floor Elevation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 10 Feb 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.
Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence flapless transcrestal sinus floor elevation is minimally invasive technique which is used in moderately defected maxilla.
Aim of the study: to evaluate both clinical and radiographic outcomes in sinus floor elevation following dental implant placement using flapless transcrestal sinus lift approach with Titanium platelet rich fibrin (TPRF) as a sole sinus graft material compared to Platelet rich fibrin (PRF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Flapless transcrestal sinus lift approach with TPRF |
| Control gorup | Active comparator | Other: Flapless transcrestal sinus lift approach with PRF |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient seeking replacement of a missed maxillary posterior teeth by a delayed dental implant procedure.
- Residual bone height is (4-7) mm measured from crestal bone to sinus floor.
- Good oral hygiene
Key exclusion criteria (6 listed)
- Uncontrolled Diabetes.
- Coagulation disorders.
- Immunological disorders.
- Previous radiation of the head and neck region.
- Abnormal bone physiology.
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 |
|---|---|---|
| Flapless transcrestal sinus lift approach with TPRFIncluding 8 patients who will be treated by flapless transcrestal sinus floor elevation using the TPRF as a sole grafting material. | Other | Study group |
| Flapless transcrestal sinus lift approach with PRFIncluding 8 patients who will be treated by flapless transcrestal sinus floor elevation using the PRF as a sole grafting material. | Other | Control gorup |
Primary outcome
Change in bone density
Time frame: Baseline and 6 months
Cuts of CBCT (cross sectional, axial and sagittal view), bone density, will be analyzed using On-demand software. The radiographic evaluation will be based on radiological parameters, using reference points and lines at T0 and T1.
2 secondary outcomes
Change in implant stability
Time frame: Baseline and 6 months
change in pain scores
Time frame: 1st day, 3rd day and 1 week
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 21 Feb 2023.
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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 Flapless transcrestal sinus lift approach with TPRF and Flapless transcrestal sinus lift approach with PRF in people with Sinus Floor Elevation, 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 3 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 21 Feb 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 bone density (time frame: Baseline and 6 months). 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 21 Feb 2023.