Alveolar Bone GraftingNCT05422196
Evaluation of Computer-Guided Secondary Alveolar Cleft Bone Grafting With and Without Platelet-Rich Fibrin
A study testing Platelet-rich fibrin in people with Alveolar Bone Grafting, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims at investigating the role of platelet-rich fibrin in alveolar cleft secondary grafting. This grafting is done from the patient's chin using a computer-guided stent that is customized for each patient, and the cleft volume is analysed at first to estimate the needed amount of bone to be harvested. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Grafting
- What is being tested?
- Platelet-rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 2 Jun 2022
- 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I.
- Patients seeking treatment and accepting to be enrolled in the study, so as their guardians.
- Patients who will age 9-14 years old by the surgery day.
- Patients with adequate chin bone volume that could be harvested without marked donor site morbidity, as pre-determined by cone beam computed tomography.
Who cannot join
- Patients with systemic illness, i.e. ASA(22) classes II, III, IV, and V.
- Patients with previously operated alveolar clefts and seeking revision for the same cleft.
- Patients that wouldn't be able to attend the recalls.
- Patients with other craniofacial anomalies and associated syndrome conditions.
- Edentulous maxilla, atypical or non-described cleft diagnosis.
- Patients with history of chemotherapy or radiotherapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Addakahlyia, 35516
About this study
This study aims at investigating the role of platelet-rich fibrin in alveolar cleft secondary grafting. This grafting is done from the patient's chin using a computer-guided stent that is customized for each patient, and the cleft volume is analysed at first to estimate the needed amount of bone to be harvested.
- Conditions
- Alveolar Bone Grafting
- Being tested
- Platelet-rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrinProcedure or surgery
Addition of platelet-rich fibrin into the cleft site.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No platelet-rich fibrin was added to the cleft site during grafting. |
| Study group | Experimental | Platelet-rich fibrin was added to the cleft site during grafting. Receives: Procedure: Platelet-rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of oronasal fistula
- By questioning the patient if there's a nasal regurgitation or not.
- Qualitative outcome (positive or negative).
Measured: Ten days postoperatively
Closure of oronasal fistula
- By questioning the patient if there's a nasal regurgitation or not.
- Qualitative outcome (positive or negative).
Measured: Six months postoperatively
Volume of newly formed bone
- By computerized measurement on the Cone-Beam Computed Tomography software. (Volume tool in Invesalius ® software (Invesalius, CTI, Brazil)).
- Quantitative outcome (in cubic millimetres (mm3)).
Measured: Six months postoperatively
Average density of newly formed bone
- By computerized measurement on the Cone-Beam Computed Tomography software. (Average density tool in Invesalius ® software (Invesalius, CTI, Brazil)).
- Quantitative outcome (in Hounsfield Units (HU)).
Measured: Six months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Oct 2020
- Primary completion1 Dec 2021
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone GraftingStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422196
- Sponsor's protocol ID
- A08080920
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Computer-Guided Secondary Alveolar Cleft Bone Grafting With and Without Platelet-Rich Fibrin
- ClinicalTrials.gov ID
- NCT05422196
- Acronym / sponsor ID
- A08080920
- Conditions
- Alveolar Bone Grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 16 Jun 2022 (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.
This study aims at investigating the role of platelet-rich fibrin in alveolar cleft secondary grafting. This grafting is done from the patient's chin using a computer-guided stent that is customized for each patient, and the cleft volume is analysed at first to estimate the needed amount of bone to be harvested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No platelet-rich fibrin was added to the cleft site during grafting. |
| Study group | Experimental | Procedure: Platelet-rich fibrinPlatelet-rich fibrin was added to the cleft site during grafting. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I.
- Patients seeking treatment and accepting to be enrolled in the study, so as their guardians.
- Patients who will age 9-14 years old by the surgery day.
- Patients with adequate chin bone volume that could be harvested without marked donor site morbidity, as pre-determined by cone beam computed tomography.
Key exclusion criteria (6 listed)
- Patients with systemic illness, i.e. ASA(22) classes II, III, IV, and V.
- Patients with previously operated alveolar clefts and seeking revision for the same cleft.
- Patients that wouldn't be able to attend the recalls.
- Patients with other craniofacial anomalies and associated syndrome conditions.
- Edentulous maxilla, atypical or non-described cleft diagnosis.
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 |
|---|---|---|
| Platelet-rich fibrinAddition of platelet-rich fibrin into the cleft site. | Procedure or surgery | Study group |
Primary outcome
Closure of oronasal fistula
Time frame: Ten days postoperatively
* By questioning the patient if there's a nasal regurgitation or not. * Qualitative outcome (positive or negative).
Closure of oronasal fistula
Time frame: Six months postoperatively
* By questioning the patient if there's a nasal regurgitation or not. * Qualitative outcome (positive or negative).
Volume of newly formed bone
Time frame: Six months postoperatively
* By computerized measurement on the Cone-Beam Computed Tomography software. (Volume tool in Invesalius ® software (Invesalius, CTI, Brazil)). * Quantitative outcome (in cubic millimetres (mm3)).
Average density of newly formed bone
Time frame: Six months postoperatively
* By computerized measurement on the Cone-Beam Computed Tomography software. (Average density tool in Invesalius ® software (Invesalius, CTI, Brazil)). * Quantitative outcome (in Hounsfield Units (HU)).
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 16 Jun 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich fibrin in people with Alveolar Bone Grafting, run by Mansoura 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 4 inclusion and 6 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 16 Jun 2022. 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?
Closure of oronasal fistula (time frame: Ten days postoperatively). The study lists 4 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 16 Jun 2022.