Implant or Graft; RejectionNCT03684954
Effect Of PRF Versus Xenograft In Closed Sinus Lift.
A study testing Prf in people with Implant or Graft; Rejection, run by Mahmoud adel shaaban.
Trial summary
Indirect sinus lift with used PRF as a graft material versus xenograft Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant or Graft; Rejection
- What is being tested?
- Prf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 30 Aug 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Edentulous area and bone high at least 5-6 mm below the maxillary sinus at maxillary premolar.
- Good oral hygiene.
Who cannot join
- bad oral hygiene.
- patient with systemic disease that may affect normal healing
- pregnant patients.
- patients with bone diseases and presence of periapical pathology affecting the neighboring teeth.
- Heavy smoker more than 20 cigarettes per day
About this study
Official title: Prf Controlled, Randamized Clinical Trial of THE EFFECT OF PLATELET RICH FIBRIN( PRF ) VERSUS XENOGRAFT IN CLOSED SINUS LIFT AND IMLANT PLACEMENT ON IMPLANT STABILITY IN PATIENTS WITH MISSING MAXILLARY PREMOLAR.
Indirect sinus lift with used PRF as a graft material versus xenograft
Read the detailed description
Crestal incision and reflect the tissue until exposure of the bone, then use drilling to make osteotomy. Then use sutable osteotomes to elevate the sinus floor, then pack of Prf or bone graft in the osteotomy and implant placement . Then closed the flap and suturing.
- Conditions
- Implant or Graft; Rejection
- Being tested
- Prf
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrfOther
Take 10 cc blood from patient and gain prf
| Study group | Role | What they receive |
|---|---|---|
| Used of PRF in clsed sinus lifting | Other | Used of PRF in closed sinus lifting with implant placement Receives: Other: Prf |
| Closed sinus with xenograft | No intervention | used of xenograft in closed sinus lift with implant placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary stability by ostell device
Implant stability will be mesured by ostell device, implant stability will be mesured intra operative at 0 ( time of implant placement ) and 2, 4, 6, 10 and 12 weeks after surgery
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 posted26 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant or Graft; RejectionStudies 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
- Model description
- Patallel Assignment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud adel shaaban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud adel shaaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684954
- Sponsor's protocol ID
- Cairo Univ.
- Status last verified
- Sep 2018
- First submitted
- 16 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prf Controlled, Randamized Clinical Trial of THE EFFECT OF PLATELET RICH FIBRIN( PRF ) VERSUS XENOGRAFT IN CLOSED SINUS LIFT AND IMLANT PLACEMENT ON IMPLANT STABILITY IN PATIENTS WITH MISSING MAXILLARY PREMOLAR.
- ClinicalTrials.gov ID
- NCT03684954
- Acronym / sponsor ID
- Cairo Univ.
- Conditions
- Implant or Graft; Rejection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mahmoud adel shaabanUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 26 Sep 2018 (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.
Indirect sinus lift with used PRF as a graft material versus xenograft
Detailed description
Crestal incision and reflect the tissue until exposure of the bone, then use drilling to make osteotomy. Then use sutable osteotomes to elevate the sinus floor, then pack of Prf or bone graft in the osteotomy and implant placement . Then closed the flap and suturing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Used of PRF in clsed sinus lifting | Other | Other: PrfUsed of PRF in closed sinus lifting with implant placement |
| Closed sinus with xenograft | No intervention | –used of xenograft in closed sinus lift with implant placement. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Edentulous area and bone high at least 5-6 mm below the maxillary sinus at maxillary premolar.
- Good oral hygiene.
Key exclusion criteria (5 listed)
- bad oral hygiene.
- patient with systemic disease that may affect normal healing
- pregnant patients.
- patients with bone diseases and presence of periapical pathology affecting the neighboring teeth.
- Heavy smoker more than 20 cigarettes per day
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 |
|---|---|---|
| PrfTake 10 cc blood from patient and gain prf | Other | Used of PRF in clsed sinus lifting |
Primary outcome
Primary stability by ostell device
Time frame: up to 3 months
Implant stability will be mesured by ostell device, implant stability will be mesured intra operative at 0 ( time of implant placement ) and 2, 4, 6, 10 and 12 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
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 Prf in people with Implant or Graft; Rejection, run by Mahmoud adel shaaban.
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 5 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: status not confirmed, as of the sponsor's last update on 26 Sep 2018. 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?
Results are not available in the source record.
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?
Primary stability by ostell device (time frame: up to 3 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 26 Sep 2018.