Sinus Floor AugmentationNCT05831267
Fibrin Glue Versus Titanium Platelet-rich Fibrin in Lateral Sinus Lifting
A study testing Fibrin Glue and T-PRF in people with Sinus Floor Augmentation and Graftless Sinus Elevation, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Graftless sinus lift with simultaneous implant placement is one of the new techniques, this new technique is presented based on the physiology of intrasinus bone repair. Schneiderian membrane is known to have an osteogenic nature, now blood clot can be considered autologous osteogenic graft material, to which… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Sinus Floor Augmentation, Graftless Sinus Elevation
- What is being tested?
- Fibrin Glue and T-PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 30 Sep 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients requiring implant placement in the posterior maxilla.
- Tooth extractions at the implant sites were performed at least 4 months before surgery.
- Residual bone height between the alveolar bone crest and the sinus floor is 3-5 mm
Who cannot join
- Maxillary sinus pathologies (sinusitis, long-standing nasal obstruction).
- Any disease-contraindicating surgery (e.g. uncontrolled diabetes).
- Heavy smokers (smoke greater than or equal 25 cigarettes daily).
- Acute oral infections.
- Untreated periodontal disease (gingival index 2 and 3).
- Poor oral hygiene ( Silness-Löe index (score 2-3) ).
- A history of radiotherapy or chemotherapy of the head and neck region.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Fibrin Glue Versus Titanium Platelet-rich Fibrin as a Sole Filling Material in Lateral Sinus Lifting With Simultaneous Implant Placement (Randomized Controlled Clinical Trial )
Graftless sinus lift with simultaneous implant placement is one of the new techniques, this new technique is presented based on the physiology of intrasinus bone repair.
Schneiderian membrane is known to have an osteogenic nature, now blood clot can be considered autologous osteogenic graft material, to which osteoprogenitors can migrate, differentiate, and regenerate bone.
The aim of this study is to evaluate the effectiveness of using Fibrin glue versus Titanium platelet rich fibrin (T-PRF) as a sole filling material in lateral sinus lifting using with simultaneous implant placement in comparison to a negative control group.
- Being tested
- Fibrin Glue, T-PRF, Negative control
- Keywords
- Tenting implant, Fibrin glue, T-PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin GlueOther
Blood samples were collected from the antecubital vein of the right or left arm of the patient and drawn into sterile Titanium tubes immediately. The tubes were then centrifuged for 12 minutes at 2800 rpm and room temperature
T-PRFOther
The contents of the two containers (human fibrinogen, human thrombin) will be mixed with distilled water and then aspirated by two syringes after that, the two solutions will be mixed together and injected into the empty compartment around the dental implant under the sinus mucosal lining using auto mixing applicator.
Negative controlOther
this group will not receive any material.
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Experimental | Not described Receives: Other: Fibrin Glue |
| Study group 2 | Experimental | Not described Receives: Other: T-PRF |
| Control group | Other | Not described Receives: Other: Negative control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in implant stability
implant stability will be measures using Ostell device.
Measured: Baseline and 6 months
change in bone density
bone density will be measured using CBCT
Measured: Baseline and 6 months
change in vertical bone height
vertical bone height will be measured using CBCT
Measured: Baseline and 6 months
Secondary outcomes (2)
change in pain intensity
This will be assessed using a 10-point Visual Analogue Scale (VAS) in the 1st week postoperatively.
(0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Measured: Through 1 week postopertaive
Change in edema score
The score will be as follows:
- None (no inflammation)
- Mild (intraoral swelling confined to the surgical field)
- Moderate (extraoral swelling in the surgical zone)
- Severe (extraoral swelling spreading beyond the surgical zone)
Measured: Through 1 week postopertaive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Feb 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Floor AugmentationStudies 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
- 30 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
- NCT05831267
- Sponsor's protocol ID
- Sinus_lifting_2022
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 26 Apr 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 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrin Glue Versus Titanium Platelet-rich Fibrin as a Sole Filling Material in Lateral Sinus Lifting With Simultaneous Implant Placement (Randomized Controlled Clinical Trial )
- ClinicalTrials.gov ID
- NCT05831267
- Acronym / sponsor ID
- Sinus_lifting_2022
- Keywords
- Tenting implant, Fibrin glue, T-PRF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 26 Apr 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.
Graftless sinus lift with simultaneous implant placement is one of the new techniques, this new technique is presented based on the physiology of intrasinus bone repair.
Schneiderian membrane is known to have an osteogenic nature, now blood clot can be considered autologous osteogenic graft material, to which osteoprogenitors can migrate, differentiate, and regenerate bone.
The aim of this study is to evaluate the effectiveness of using Fibrin glue versus Titanium platelet rich fibrin (T-PRF) as a sole filling material in lateral sinus lifting using with simultaneous implant placement in comparison to a negative control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | Experimental | Other: Fibrin Glue |
| Study group 2 | Experimental | Other: T-PRF |
| Control group | Other | Other: Negative control |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients requiring implant placement in the posterior maxilla.
- Tooth extractions at the implant sites were performed at least 4 months before surgery.
- Residual bone height between the alveolar bone crest and the sinus floor is 3-5 mm
Key exclusion criteria (8 listed)
- Maxillary sinus pathologies (sinusitis, long-standing nasal obstruction).
- Any disease-contraindicating surgery (e.g. uncontrolled diabetes).
- Heavy smokers (smoke greater than or equal 25 cigarettes daily).
- Acute oral infections.
- Untreated periodontal disease (gingival index 2 and 3).
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 |
|---|---|---|
| Fibrin GlueBlood samples were collected from the antecubital vein of the right or left arm of the patient and drawn into sterile Titanium tubes immediately. The tubes were then centrifuged for 12 minutes at 2800 rpm and room temperature | Other | Study group 1 |
| T-PRFThe contents of the two containers (human fibrinogen, human thrombin) will be mixed with distilled water and then aspirated by two syringes after that, the two solutions will be mixed together and injected into the empty compartment around the dental implant under the sinus mucosal lining using auto mixing applicator. | Other | Study group 2 |
| Negative controlthis group will not receive any material. | Other | Control group |
Primary outcome
change in implant stability
Time frame: Baseline and 6 months
implant stability will be measures using Ostell device.
change in bone density
Time frame: Baseline and 6 months
bone density will be measured using CBCT
change in vertical bone height
Time frame: Baseline and 6 months
vertical bone height will be measured using CBCT
2 secondary outcomes
change in pain intensity
Time frame: Through 1 week postopertaive
Change in edema score
Time frame: Through 1 week postopertaive
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 Apr 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 Fibrin Glue and T-PRF in people with Sinus Floor Augmentation and Graftless Sinus 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 8 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 Apr 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 implant stability (time frame: Baseline and 6 months). The study lists 3 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 26 Apr 2023.