Alveolar Ridge AbnormalityNCT03302429
Evaluation of Platelet Rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft
A study testing PRF/ BCP and Autogenous bone graft in people with Alveolar Ridge Abnormality, run by Cairo University at 1 site in Egypt.
Trial summary
P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial this study aimed to answer a clinical question… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Alveolar Ridge Abnormality
- What is being tested?
- PRF/ BCP and Autogenous bone graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Nov 2017to 30 Mar 2023
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suffering from maxillary alveolar cleft
- Patients' age 8 years and older
Who cannot join
- Syndromic cases will be excluded
- Patients suffering from platelets disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Platelet-rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft Defect in the Maxillary Arch: Randomized Controlled Clinical Trial
P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch.
Read the detailed description
this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch
- Conditions
- Alveolar Ridge Abnormality
- Being tested
- PRF/ BCP, Autogenous bone graft
- Keywords
- Alveolar cleft -Platelet rich fibrin- calcium phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF/ BCPOther
Also called Easy-graft/BCP
Platelet rich fibrin combined with biphasic calcium phosphate(experimental group)
Autogenous bone graftOther
Bone obtained from the same individual who receiving the graft
| Study group | Role | What they receive |
|---|---|---|
| PRF/ BCP | Experimental | Biphasic calcium phosphate (BCP)"bioceramic bone substitute combined with platelet rich fibrin PRF Receives: Other: PRF/ BCP |
| autogenous bone graft | Active comparator | Autogenous bone graft involving utilizing bone obtained from the same individual receiving the graft Receives: Other: Autogenous bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone height
the vertical bone height measured from the most coronal level of the pyriform aperture to the most apical level of the bony bridge.
Measured: six months postoperative.
Secondary outcomes (3)
bone volume
V= (A1xT) + ( A2 xT) + …….+ (An xT) where:
V= volume A= area T= thickness of the axial C.T slice N=number of slices
Measured: six months postoperative.
operation duration
It is the time elapsed between using the scalable for incision and the last stitch.
It will be measured by watch in hours.
Measured: within 4 hours ( the actual number of hours will be determined intra-operative )
hospital stay
Number of days that patients spend in hospital. Measured by calendar, starting from time of admission ending with time of discharge
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start19 Nov 2017
- Primary completion27 Jan 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AbnormalityStudies 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
- Model description
- Eighteen patients will be divided into two equal groups. Each group comprises nine patients. Group A: Platelet-rich Fibrin combined with Biphasic Calcium Phosphate.(interventional group) Group B: autogenous bone graft (controlled group)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah G Samra El-Shamy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302429
- Sponsor's protocol ID
- CEBD-CU-2017-09-31
- Status last verified
- Oct 2017
- First submitted
- 1 Oct 2017
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Platelet-rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft Defect in the Maxillary Arch: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03302429
- Acronym / sponsor ID
- CEBD-CU-2017-09-31
- Conditions
- Alveolar Ridge Abnormality
- Keywords
- Alveolar cleft -Platelet rich fibrin- calcium phosphate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Nov 2017 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 5 Oct 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.
P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch.
Detailed description
this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eighteen patients will be divided into two equal groups. Each group comprises nine patients. Group A: Platelet-rich Fibrin combined with Biphasic Calcium Phosphate.(interventional group) Group B: autogenous bone graft (controlled group)
| Arm | Type | Receives |
|---|---|---|
| PRF/ BCP | Experimental | Other: PRF/ BCPBiphasic calcium phosphate (BCP)"bioceramic bone substitute combined with platelet rich fibrin PRF |
| autogenous bone graft | Active comparator | Other: Autogenous bone graftAutogenous bone graft involving utilizing bone obtained from the same individual receiving the graft |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suffering from maxillary alveolar cleft
- Patients' age 8 years and older
Key exclusion criteria (2 listed)
- Syndromic cases will be excluded
- Patients suffering from platelets disorders.
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 |
|---|---|---|
| PRF/ BCPAlso: Easy-graft/BCPPlatelet rich fibrin combined with biphasic calcium phosphate(experimental group) | Other | PRF/ BCP |
| Autogenous bone graftBone obtained from the same individual who receiving the graft | Other | autogenous bone graft |
Primary outcome
bone height
Time frame: six months postoperative.
the vertical bone height measured from the most coronal level of the pyriform aperture to the most apical level of the bony bridge.
3 secondary outcomes
bone volume
Time frame: six months postoperative.
operation duration
Time frame: within 4 hours ( the actual number of hours will be determined intra-operative )
hospital stay
Time frame: within 7 days
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 4 Nov 2024.
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Immediate Dental Implant Placement, Defect in Alveolar Ridge
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 PRF/ BCP and Autogenous bone graft in people with Alveolar Ridge Abnormality, run by Cairo 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 2 inclusion and 2 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 4 Nov 2024. 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?
bone height (time frame: six months postoperative.). 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 4 Nov 2024.