Immediate Dental ImplantNCT03183349
Immediate Implant Placement With Platlet Rich Fibrin as Space Filling Material Versus the Use of Deprotienized Bovine Bone (Tutogen) in Maxillary Premolars.
A study testing deprotienized bovine bone (tutogen) and platelet rich fibrin in people with Immediate Dental Implant, run by Cairo University.
Trial summary
20 subjects suffering from non restorable maxillary premolar teeth will be randomly devided into two groups. the selected teeth will be extracted and immeiate implants will be placed in all subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant
- What is being tested?
- deprotienized bovine bone (tutogen) and platelet rich fibrin
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non restorable maxillary premolars non smoker free from any systemic disease or medication that could impair normal bone healing
Who cannot join
- any systemic disease that could affect bone healing patient with lesion related to the surgical site
About this study
Official title: Immediate Implant Placement With Platlet Rich Fibrin as Space Filling Material Versus the Use of Deprotienized Bovine Bone (Tutogen) in Maxillary Premolars. A Randomized Controlled Clinical Trial
20 subjects suffering from non restorable maxillary premolar teeth will be randomly devided into two groups. the selected teeth will be extracted and immeiate implants will be placed in all subjects. the first group will recieve deprotienized bovine bone (tutogen) to fill the buccal space between the implant and the bone, the second group will recieve platlet rich fibrin to fill the buccal space between the implant and the bone
- Conditions
- Immediate Dental Implant
- Being tested
- deprotienized bovine bone (tutogen), platelet rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deprotienized bovine bone (tutogen)Procedure or surgery
platelet rich fibrinProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| platelet rich fibrin | Experimental | immediate implant grafting Receives: Procedure: deprotienized bovine bone (tutogen) |
| deprotienized bovine bone (tutogen) | Active comparator | immediate implant grafting Receives: Procedure: platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient morbidity
patient pain level on pain scale using pain chart
Measured: 14 days
Secondary outcomes (2)
crestal bone loss
radiographic analysis computing amount of crestal bone loss around implants using cone beam computed tomography
Measured: 3 months
implants stability quotient
implant stability measured using resonance frequency analysis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study startJul 2016
- Primary completionJun 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 Immediate Dental ImplantStudies 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 mohamed awad elbrashy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183349
- Sponsor's protocol ID
- cebc.Cairouni
- Status last verified
- Jun 2017
- First submitted
- 6 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement With Platlet Rich Fibrin as Space Filling Material Versus the Use of Deprotienized Bovine Bone (Tutogen) in Maxillary Premolars. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03183349
- Acronym / sponsor ID
- cebc.Cairouni
- Conditions
- Immediate Dental Implant
- 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
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 12 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 subjects suffering from non restorable maxillary premolar teeth will be randomly devided into two groups. the selected teeth will be extracted and immeiate implants will be placed in all subjects. the first group will recieve deprotienized bovine bone (tutogen) to fill the buccal space between the implant and the bone, the second group will recieve platlet rich fibrin to fill the buccal space between the implant and the bone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet rich fibrin | Experimental | Procedure: deprotienized bovine bone (tutogen)immediate implant grafting |
| deprotienized bovine bone (tutogen) | Active comparator | Procedure: platelet rich fibrinimmediate implant grafting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- non restorable maxillary premolars non smoker free from any systemic disease or medication that could impair normal bone healing
Key exclusion criteria (1 listed)
- any systemic disease that could affect bone healing patient with lesion related to the surgical site
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 |
|---|---|---|
| deprotienized bovine bone (tutogen) | Procedure or surgery | platelet rich fibrin |
| platelet rich fibrin | Procedure or surgery | deprotienized bovine bone (tutogen) |
Primary outcome
Patient morbidity
Time frame: 14 days
patient pain level on pain scale using pain chart
2 secondary outcomes
crestal bone loss
Time frame: 3 months
implants stability quotient
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: Yes
Related trials for Immediate Dental Implant
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
RecruitingPhase 2/3
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Dental Implant, Wound Healing
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Recruiting
Graftless Periosteal Coverage Versus Xenogenic Graft for Jumping Gap Management in Immediate Mandibular Molar Implants
Dental Implants
Recruiting
Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
Dental Implant, Immediate Dental Implant Placement
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 deprotienized bovine bone (tutogen) and platelet rich fibrin in people with Immediate Dental Implant, 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 1 inclusion and 1 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 14 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 morbidity (time frame: 14 days). 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 14 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.