Edentulous Alveolar RidgeNCT03177356
Implant Placement in Mandibular Molar Xenograft Versus PRF
A study testing extraction,implant placement,PRF and Exctraction,Implant placement,Bone graft in people with Edentulous Alveolar Ridge, run by Cairo University.
Trial summary
20 recruited patients indicated for immediate implant placement in mandibular molar patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone after molar extraction and immediate implant placement, while the other group we use Platelet-rich fibrin as space… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- extraction,implant placement,PRF and Exctraction,Implant placement,Bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-restorable mandibular molars
- Both sexes
- -
Who cannot join
- • Heavy smokers more than 20 cigarettes per day.5
- Patients with in sufficient interseptal bone height and width
- Patients with systemic disease that may affect normal healing.
- Patients with completely resorbed buccal cortical plate.
About this study
Official title: Immediate Implant Placement With Deproteinized Bovine Bone (Tutogen) Versus Placement of Platelet-rich Fibrin as a Space Filling Material in Mandibular Molars. Randomized Clinical Trial.
20 recruited patients indicated for immediate implant placement in mandibular molar patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone after molar extraction and immediate implant placement, while the other group we use Platelet-rich fibrin as space filling material.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- extraction,implant placement,PRF, Exctraction,Implant placement,Bone graft
- Keywords
- Platelet rich fibrin,xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extraction,implant placement,PRFProcedure or surgery
Surgical extraction of mandibular molar using periotome and forceps followed by implant placement in inter-septal bone. Then a blood sample is withdrawn from patient and placed in the centrifuge. Then Platelet-Rich fibrin is placed in the extraction socket as space filling material
Exctraction,Implant placement,Bone graftProcedure or surgery
Surgical extraction of mandibular molar using extraction forceps and periotome followed by implant placement in interseptal bone. De-proteinized bovine bone graft material is placed as space filling material
| Study group | Role | What they receive |
|---|---|---|
| extraction,implant placement,PRF | Experimental | Extraction of Mandibular first molar and Implant placement followed by Placement of placement of Platelet rich fibrin as space filling material Receives: Procedure: extraction,implant placement,PRF |
| Exctraction,Implant placement,Bone graft | Active comparator | Extraction of mandibular first molar followed by implant placement and xenogenic bone graft as space filling material Receives: Procedure: Exctraction,Implant placement,Bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
evaluation of postoperative complications regarding pain and oedema
Measured: 1 week post operative
Secondary outcomes (2)
implant stability
measurement of implant stability using osstell device
Measured: will be measure intraopertively immediately after insertion of the implants and will be measure one more time 6 months after 1st operation at the time of exposure of implants
amount of bone gained or lost around the implants
two cone beam computed tomography (CBCT) will be taken for the patient, one immediate postoperative and the other 6 months after the operation then the height of bone gained or lost around the implants will be assessed by superimposing the same section in the two CBCTS
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hussein El Garhy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177356
- Sponsor's protocol ID
- cebc.cairouniversity
- Status last verified
- Jun 2017
- First submitted
- 3 Jun 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement With Deproteinized Bovine Bone (Tutogen) Versus Placement of Platelet-rich Fibrin as a Space Filling Material in Mandibular Molars. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03177356
- Acronym / sponsor ID
- cebc.cairouniversity
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- Platelet rich fibrin,xenograft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 6 Jun 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.
20 recruited patients indicated for immediate implant placement in mandibular molar patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone after molar extraction and immediate implant placement, while the other group we use Platelet-rich fibrin as space filling material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extraction,implant placement,PRF | Experimental | Procedure: extraction,implant placement,PRFExtraction of Mandibular first molar and Implant placement followed by Placement of placement of Platelet rich fibrin as space filling material |
| Exctraction,Implant placement,Bone graft | Active comparator | Procedure: Exctraction,Implant placement,Bone graftExtraction of mandibular first molar followed by implant placement and xenogenic bone graft as space filling material |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with non-restorable mandibular molars
- Both sexes
- -
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| extraction,implant placement,PRFSurgical extraction of mandibular molar using periotome and forceps followed by implant placement in inter-septal bone. Then a blood sample is withdrawn from patient and placed in the centrifuge. Then Platelet-Rich fibrin is placed in the extraction socket as space filling material | Procedure or surgery | extraction,implant placement,PRF |
| Exctraction,Implant placement,Bone graftSurgical extraction of mandibular molar using extraction forceps and periotome followed by implant placement in interseptal bone. De-proteinized bovine bone graft material is placed as space filling material | Procedure or surgery | Exctraction,Implant placement,Bone graft |
Primary outcome
Patient satisfaction
Time frame: 1 week post operative
evaluation of postoperative complications regarding pain and oedema
2 secondary outcomes
implant stability
Time frame: will be measure intraopertively immediately after insertion of the implants and will be measure one more time 6 months after 1st operation at the time of exposure of implants
amount of bone gained or lost around the implants
Time frame: 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing extraction,implant placement,PRF and Exctraction,Implant placement,Bone graft in people with Edentulous Alveolar Ridge, run by Cairo 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 3 inclusion and 4 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 6 Jun 2017. 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?
Patient satisfaction (time frame: 1 week post operative). 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 6 Jun 2017.