Bone LossNCT04298294
Using of Injectable Platelet Rich Fibrin on Filling the Gap of Immediate Dental Implant
A study testing injectable platelet rich fibrin in people with Bone Loss, run by Ain Shams University at 1 site in Egypt.
Trial summary
The effect of using of i-PRF (injectable platelet rich fibrin) on filling the gap of immediate dental implant in the esthetic zone Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- injectable platelet rich fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Feb 2018to 1 Dec 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult patient.
- Age from 20-50 years old
- Patients must be free of any systemic disease which could influence the surgical procedure.
- Tooth involved in the esthetic zone.
- Sufficient hard and soft tissue volume in vertical and buccolingual 6. Natural teeth adjacent to the involved tooth were required to be free from infection.
- Controlled oral hygiene.
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- Indication for tooth extraction included;
- Endodontic failures
- Untreatable caries> Non- restorable teeth
- Vertical root fracture
- Remaining roots
- The decision to proceed with the implant placement was made after tooth extraction and probing of the extraction socket which revealed:
- The presence of intact facial bone.
- Compliance with all requirements in the study and signing the informed consent.
Who cannot join
- Patient had surgeries in the same site during the last 6 months prior to the surgery.
- Severe vertical bone loss (socket type lll or type lV).
- Presence of acute dento-alveolar infection or periodontal affected of involved tooth.
- Pregnant and lactating females.
- Smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using of Injectable Platelet Rich Fibrin on Filling the Gap of Immediate Dental Implant in the Esthetic Zone
The effect of using of i-PRF (injectable platelet rich fibrin) on filling the gap of immediate dental implant in the esthetic zone
Read the detailed description
Grouping the samples: (sixteen patients was recruited from the outpatient clinic of Oral Medicine, Periodontology, Diagnosis and Radiology Department, Faculty of Dentistry, Ain Shams University).
The sixteen patients assigned to group 1 or group 2 will be randomly allocated using flip of a coin into one of the 2 treatment modalities.
Primary objective:
Radiograhic evaluation of the effect of i-PRF on filling the buccal gap distance between the immediately placed dental implant and the surrounding bone.
Secondary objective:
Esthetic evaluation of the effect of i-PRF on the soft tissue around immediately placed dental implant.
- Conditions
- Bone Loss
- Being tested
- injectable platelet rich fibrin
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable platelet rich fibrinOther
biologic activator
| Study group | Role | What they receive |
|---|---|---|
| injectable platelet rich fibrin group | Experimental | 8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with i-PRF\& bone graft Receives: Other: injectable platelet rich fibrin |
| no injectable platelet rich fibrin group | No intervention | 8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiograhic evaluation of the effect of i-PRF on filling the buccal gap distance between the immediately placed dental implant and the surrounding bone.
density, vertical and horizontal assessment of labial plate
Measured: 6 months follow up
Radiographic analysis
vertical assessment of labial plate
Measured: 6 months follow up
Radiographic analysis
density of labial plate
Measured: 6 months follow up
Secondary outcomes (1)
Esthetic evaluation of the effect of i-PRF on the soft tissue around immediately placed dental implant
pink esthetic score
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start16 Feb 2018
- Primary completion1 Oct 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I (study group)8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with i-PRF\& bone graft Group II (control group) 8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with bone graft
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant Mohye, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298294
- Sponsor's protocol ID
- Bassant Mohye
- Status last verified
- Mar 2020
- First submitted
- 29 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using of Injectable Platelet Rich Fibrin on Filling the Gap of Immediate Dental Implant in the Esthetic Zone
- ClinicalTrials.gov ID
- NCT04298294
- Acronym / sponsor ID
- Bassant Mohye
- Conditions
- Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 6 Mar 2020 (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.
The effect of using of i-PRF (injectable platelet rich fibrin) on filling the gap of immediate dental implant in the esthetic zone
Detailed description
Grouping the samples: (sixteen patients was recruited from the outpatient clinic of Oral Medicine, Periodontology, Diagnosis and Radiology Department, Faculty of Dentistry, Ain Shams University).
The sixteen patients assigned to group 1 or group 2 will be randomly allocated using flip of a coin into one of the 2 treatment modalities.
Primary objective:
Radiograhic evaluation of the effect of i-PRF on filling the buccal gap distance between the immediately placed dental implant and the surrounding bone.
Secondary objective:
Esthetic evaluation of the effect of i-PRF on the soft tissue around immediately placed dental implant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group I (study group)8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with i-PRF\& bone graft Group II (control group) 8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with bone graft
| Arm | Type | Receives |
|---|---|---|
| injectable platelet rich fibrin group | Experimental | Other: injectable platelet rich fibrin8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with i-PRF\& bone graft |
| no injectable platelet rich fibrin group | No intervention | –8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with bone graft |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy adult patient.
- Age from 20-50 years old
- Patients must be free of any systemic disease which could influence the surgical procedure.
- Tooth involved in the esthetic zone.
- Sufficient hard and soft tissue volume in vertical and buccolingual 6. Natural teeth adjacent to the involved tooth were required to be free from infection.
Key exclusion criteria (5 listed)
- Patient had surgeries in the same site during the last 6 months prior to the surgery.
- Severe vertical bone loss (socket type lll or type lV).
- Presence of acute dento-alveolar infection or periodontal affected of involved tooth.
- Pregnant and lactating females.
- Smokers.
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 |
|---|---|---|
| injectable platelet rich fibrinbiologic activator | Other | injectable platelet rich fibrin group |
Primary outcome
Radiograhic evaluation of the effect of i-PRF on filling the buccal gap distance between the immediately placed dental implant and the surrounding bone.
Time frame: 6 months follow up
density, vertical and horizontal assessment of labial plate
Radiographic analysis
Time frame: 6 months follow up
vertical assessment of labial plate
Radiographic analysis
Time frame: 6 months follow up
density of labial plate
1 secondary outcome
Esthetic evaluation of the effect of i-PRF on the soft tissue around immediately placed dental implant
Time frame: 6 months follow up
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 6 Mar 2020.
- Individual participant dataSharing planned: No
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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 injectable platelet rich fibrin in people with Bone Loss, run by Ain Shams University 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 14 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: finished, as of the sponsor's last update on 6 Mar 2020. 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?
Radiograhic evaluation of the effect of i-PRF on filling the buccal gap distance between the immediately placed dental implant and the surrounding bone. (time frame: 6 months follow up). 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 6 Mar 2020.