Alveolar Cleft GraftingPhase 2NCT03016793
Alveolar Cleft Grafting Using Two Different Alloplastic Grafts
A Phase 2 study testing Puerarin, β- tricalcium phosphate and β- tricalcium phosphate alone in people with Alveolar Cleft Grafting, run by Cairo University at 1 site in Egypt.
Trial summary
P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number 0-10 Radiographic outcome: Outcome name… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Cleft Grafting
- What is being tested?
- Puerarin, β- tricalcium phosphate and β- tricalcium phosphate alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Dec 2017
- Phase
- Phase 2
- 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 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with unilateral alveolar cleft indicated for bone grafting.
- Patients age range between 8-12years.
Who cannot join
- Patients with any systemic diseases that can affect normal bone and/or wound healing.
- Patients with bilateral alveolar clefts.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mohamad hamed Maklad
Suez
Mohamd H Maklad, BSC, +201002648553, dentomaklad@yahoo.com
About this study
Official title: Evaluation of Esthetic Satisfaction and Bone Augmentation Quality Using Purabone Added to β-tricalcium Phosphate Versus β-tricalcium Phosphate Alone in Secondry Alveolar Cleft Grafting . Randomized Controlled Clinical Trial
P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number 0-10
Radiographic outcome:
Outcome name Measurment Device Measurment unite Bone volume
(Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density
(Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying than tricalcium phosphate alone in alveolar cleft grafting?
- Conditions
- Alveolar Cleft Grafting
- Being tested
- Puerarin, β- tricalcium phosphate, β- tricalcium phosphate alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuerarinDrug
Also called purabone
purabone (puerarin) is a bone graft used for surgical repair of bony defects.
β- tricalcium phosphateDrug
β- tricalcium phosphate is a bone graft used for surgical repair of bony defects
β- tricalcium phosphate aloneDrug
Also called β- tricalcium phosphate
β- tricalcium phosphate is a bone graft used for surgical repair of bony defects
| Study group | Role | What they receive |
|---|---|---|
| puerarin and β- tricalcium phosphate | Experimental | purabone (puerarin) is an osteoinductive bone grafts used to augment bone healing.
β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing Receives: Drug: Puerarin; Drug: β- tricalcium phosphate |
| β- tricalcium phosphate alone | Active comparator | β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing Receives: Drug: β- tricalcium phosphate alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetic satisfaction
outcome measured by numerical scale from 1-10
Measured: 6 months
Secondary outcomes (2)
bone volume
outcome measured by cone beam computed tomography ( CBCT)
Measured: 6 months
bone density
Outcome measured by cone beam computed tomography (CBCT)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Cleft GraftingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Hamed Maklad, Cairo University
- Investigators
- Samar Swelam, Phd, Study director, faculty of oral and dental medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016793
- Sponsor's protocol ID
- Pura-28568
- Status last verified
- Jan 2017
- First submitted
- 23 Dec 2016
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Esthetic Satisfaction and Bone Augmentation Quality Using Purabone Added to β-tricalcium Phosphate Versus β-tricalcium Phosphate Alone in Secondry Alveolar Cleft Grafting . Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03016793
- Acronym / sponsor ID
- Pura-28568
- Conditions
- Alveolar Cleft Grafting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- 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-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number 0-10
Radiographic outcome:
Outcome name Measurment Device Measurment unite Bone volume
(Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density
(Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying than tricalcium phosphate alone in alveolar cleft grafting?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| puerarin and β- tricalcium phosphate | Experimental | Drug: Puerarin, Drug: β- tricalcium phosphatepurabone (puerarin) is an osteoinductive bone grafts used to augment bone healing. β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing |
| β- tricalcium phosphate alone | Active comparator | Drug: β- tricalcium phosphate aloneβ- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with unilateral alveolar cleft indicated for bone grafting.
- Patients age range between 8-12years.
Key exclusion criteria (2 listed)
- Patients with any systemic diseases that can affect normal bone and/or wound healing.
- Patients with bilateral alveolar clefts.
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 |
|---|---|---|
| PuerarinAlso: purabonepurabone (puerarin) is a bone graft used for surgical repair of bony defects. | Drug | puerarin and β- tricalcium phosphate |
| β- tricalcium phosphateβ- tricalcium phosphate is a bone graft used for surgical repair of bony defects | Drug | puerarin and β- tricalcium phosphate |
| β- tricalcium phosphate aloneAlso: β- tricalcium phosphateβ- tricalcium phosphate is a bone graft used for surgical repair of bony defects | Drug | β- tricalcium phosphate alone |
Primary outcome
Esthetic satisfaction
Time frame: 6 months
outcome measured by numerical scale from 1-10
2 secondary outcomes
bone volume
Time frame: 6 months
bone density
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Alveolar Cleft Grafting
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Cleft Lip Palate
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Bone Augmentation Techniques in the Mandible Posterior Region
Bone Substitutes, Alveolar Bone Grafting
Not yet recruitingPhase 3
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
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Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique
Alveolar Cleft Grafting
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.
Samar Swelam, Phd study director
faculty of oral and dental medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Puerarin, β- tricalcium phosphate and β- tricalcium phosphate alone in people with Alveolar Cleft Grafting, 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: status not confirmed, as of the sponsor's last update on 11 Jan 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Mohamed H Maklad, BSC (+201002648553, dentomaklad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esthetic satisfaction (time frame: 6 months). 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 11 Jan 2017.