Bone Density IncreasedNCT03626779
Bone Density in Immediate Implant Placment and Loading(BDIIPL)
A study testing Prf in people with Bone Density Increased, run by Ahmed adel shaaban.
Trial summary
Atrumatic extraction ,immediate implant placment , prf as plug,immediate loading , mesure bone density 0-3-6-9 month Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Density Increased
- 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 Sep 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- unrestorable anterior tooth.
- Good oral hygine
- Adequate bone hieght apical to the alveolus of failing tooth to ensure primary stability .
Who cannot join
- systematic disease which affect osteointgration.
- Bad oral hygiene
- Broxism, clenching, deep bite, edge to edge and abnormal habits.
- Non-treated peeiodontal diseases.
- Pregnancy and smokers. Severe infection. Loss of labial crest after extraction of failing tooth.
About this study
Official title: Prf Controlled,Randamized Cinical Trial of EFFECTS OF THE PLATELET-RICH FIBRIN (PRF) ON BONE DENSITY IN IMMEDIATE IMPLANT PLACEMENT AND LOADING IN ESTHETIC ZONE
Atrumatic extraction ,immediate implant placment , prf as plug,immediate loading , mesure bone density 0-3-6-9 month
Read the detailed description
Atrumatic extraction unrestorable tooth in esthetic zone and immediate implant placment and withdrow 10cc blood sample to gain prf plug as membrane and immediate provisional for one week and final restoration after 1 week , and mesure bone density from 0-3-6-9 month
- Conditions
- Bone Density Increased
- Being tested
- Prf
- Medical subject headings
- Osteosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrfOther
Take 10cc blood from patient and gain prf blug
| Study group | Role | What they receive |
|---|---|---|
| immediate placment and loading with prf | Other | Immediat placment and loading with prf Receives: Other: Prf |
| immediate implant placment and loading | No intervention | Immediate implant placment and loading without prf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density enhancement with prf in immediate implant placment and loding
Cbct
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Sep 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 Bone Density IncreasedStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed adel shaaban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed adel shaaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626779
- Sponsor's protocol ID
- Cairo U
- Status last verified
- Aug 2018
- First submitted
- 30 Jul 2018
- Last updated
- 22 Aug 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 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prf Controlled,Randamized Cinical Trial of EFFECTS OF THE PLATELET-RICH FIBRIN (PRF) ON BONE DENSITY IN IMMEDIATE IMPLANT PLACEMENT AND LOADING IN ESTHETIC ZONE
- ClinicalTrials.gov ID
- NCT03626779
- Acronym / sponsor ID
- Cairo U
- Conditions
- Bone Density Increased
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ahmed adel shaabanUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 13 Aug 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.
Atrumatic extraction ,immediate implant placment , prf as plug,immediate loading , mesure bone density 0-3-6-9 month
Detailed description
Atrumatic extraction unrestorable tooth in esthetic zone and immediate implant placment and withdrow 10cc blood sample to gain prf plug as membrane and immediate provisional for one week and final restoration after 1 week , and mesure bone density from 0-3-6-9 month
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate placment and loading with prf | Other | Other: PrfImmediat placment and loading with prf |
| immediate implant placment and loading | No intervention | –Immediate implant placment and loading without prf |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- unrestorable anterior tooth.
- Good oral hygine
- Adequate bone hieght apical to the alveolus of failing tooth to ensure primary stability .
Key exclusion criteria (5 listed)
- systematic disease which affect osteointgration.
- Bad oral hygiene
- Broxism, clenching, deep bite, edge to edge and abnormal habits.
- Non-treated peeiodontal diseases.
- Pregnancy and smokers. Severe infection. Loss of labial crest after extraction of failing tooth.
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 10cc blood from patient and gain prf blug | Other | immediate placment and loading with prf |
Primary outcome
Bone density enhancement with prf in immediate implant placment and loding
Time frame: 9 month
Cbct
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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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 Prf in people with Bone Density Increased, run by Ahmed 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 3 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 22 Aug 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?
Bone density enhancement with prf in immediate implant placment and loding (time frame: 9 month). 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 22 Aug 2018.