Cleft; Alveolar ProcessEarly Phase 1NCT03420287
Evaluation of MPM Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized Clinical Trial
A Early Phase 1 study testing MPM Prepared From Allogenic Bone Graft and Autogenous bone in people with Cleft; Alveolar Process, run by Cairo University.
Trial summary
The aim of this trial is to figure out the efficiency of Mineralized Plasmatic Matrix prepared from allogenic bone graft on cleft alveolus and oro-nasal fistula closure, adequate bone volume and acceptable density at the site of grafting.MPM might improve the physiological properties of allogenic bone graft and… Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cleft; Alveolar Process
- What is being tested?
- MPM Prepared From Allogenic Bone Graft and Autogenous bone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Apr 2019
- Phase
- Early Phase 1
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Unilateral or bilateral alveolar cleft patients
Who cannot join
- patients with previous failed alveolar cleft grafting procedure.
About this study
Official title: Evaluation of Mineralized Plasmatic Matrix Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized, Triple Blinded, Parallel Clinical Trial
The aim of this trial is to figure out the efficiency of Mineralized Plasmatic Matrix prepared from allogenic bone graft on cleft alveolus and oro-nasal fistula closure, adequate bone volume and acceptable density at the site of grafting.MPM might improve the physiological properties of allogenic bone graft and facilitate its handling and application during surgical grafting.This might decrease the need of the second surgical site for harvesting autogenous bone to be grafted with its all complications and hurdles.This trial will help the practitioners in taking the decision of using the MPM prepared from allogenic bone in alveolar cleft closure or not.
Read the detailed description
Alveolar bone grafting will be performed at 6 to 12 years of age as following :
Group (A):Will undergo grafting with anterior iliac crest bone,(Control group). Group (B):Will undergo grafting with Mineralized Plasmatic Matrix prepared from allogenic bone graft (study group).
In all patients, this will be the first bone graft to be placed in the alveolar cleft. All patients will be monitored clinically and radiographically (by cone beam C.T) for up to 6 months after surgery.
- Conditions
- Cleft; Alveolar Process
- Being tested
- MPM Prepared From Allogenic Bone Graft, Autogenous bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPM Prepared From Allogenic Bone GraftCombination product
patients will receive a sticky bone which prepared by mixing the the growth factors of the patient with allogenic bone graft for cleft closure
Autogenous boneOther
patients will receive an autogenous bone graft from anterior iliac crest for cleft closure
| Study group | Role | What they receive |
|---|---|---|
| MPM prepared from allogenic bone graft | Experimental | All patients in this group will receive MPM prepared from allogenic bone graft Receives: Combination Product: MPM Prepared From Allogenic Bone Graft |
| Autogenous bone graft group | Active comparator | All patients in this group will receive autogenous bone graft only Receives: Other: Autogenous bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oro-nasal Fistula
it will be assessed visually and by questionnaire with binary measuring unit (present or not).• Examination of oro-nasal Fistula will be done by using the following diagnostic criteria: 1.Air escape from the opening when patient blows his/her nose.
2.An obvious communication between the opening and floor of the nasal cavity. 3.Unobstructed penetration of Guttapercha through the opening into the nasal cavity.
4.Hypernasality of voice due to audible nasal air escape during speech. 5.Nasal regurgitation of fluids. 6.Food lodgement into nasal cavity with risk of rhinitis .
Measured: 6 months
Secondary outcomes (2)
C.T analysis of secondary bone grafts
it will be assessed by Chelsea Scale which radio-graphically analyzing the position of the bone tissue in relation to the teeth adjacent to the cleft and separating the images into 6 categories: A,B,C,D, E,F.
Bone grafts of types A,B and C according to the Chelsea scale were considered satisfactory, whereas the other types were considered unsatisfactory
Measured: 6 months
Donor site long standing pain
it will be assessed by Numeric Rating Scale (NRS).Numeric Rating ScaleUsing the NPRS which is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line.
(NRS).0 means no pain, 5 means moderate pain and 10 means worst possible pain.
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 posted5 Feb 2018
- Study startApr 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft; Alveolar ProcessStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420287
- Sponsor's protocol ID
- CEBD-CU-2018-01-02
- Status last verified
- Jan 2018
- First submitted
- 28 Jan 2018
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mineralized Plasmatic Matrix Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized, Triple Blinded, Parallel Clinical Trial
- ClinicalTrials.gov ID
- NCT03420287
- Acronym / sponsor ID
- CEBD-CU-2018-01-02
- Conditions
- Cleft; Alveolar Process
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 5 Feb 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.
The aim of this trial is to figure out the efficiency of Mineralized Plasmatic Matrix prepared from allogenic bone graft on cleft alveolus and oro-nasal fistula closure, adequate bone volume and acceptable density at the site of grafting.MPM might improve the physiological properties of allogenic bone graft and facilitate its handling and application during surgical grafting.This might decrease the need of the second surgical site for harvesting autogenous bone to be grafted with its all complications and hurdles.This trial will help the practitioners in taking the decision of using the MPM prepared from allogenic bone in alveolar cleft closure or not.
Detailed description
Alveolar bone grafting will be performed at 6 to 12 years of age as following :
Group (A):Will undergo grafting with anterior iliac crest bone,(Control group). Group (B):Will undergo grafting with Mineralized Plasmatic Matrix prepared from allogenic bone graft (study group).
In all patients, this will be the first bone graft to be placed in the alveolar cleft. All patients will be monitored clinically and radiographically (by cone beam C.T) for up to 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPM prepared from allogenic bone graft | Experimental | Combination Product: MPM Prepared From Allogenic Bone GraftAll patients in this group will receive MPM prepared from allogenic bone graft |
| Autogenous bone graft group | Active comparator | Other: Autogenous boneAll patients in this group will receive autogenous bone graft only |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral or bilateral alveolar cleft patients
Key exclusion criteria (1 listed)
- patients with previous failed alveolar cleft grafting procedure.
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 |
|---|---|---|
| MPM Prepared From Allogenic Bone Graftpatients will receive a sticky bone which prepared by mixing the the growth factors of the patient with allogenic bone graft for cleft closure | Combination product | MPM prepared from allogenic bone graft |
| Autogenous bonepatients will receive an autogenous bone graft from anterior iliac crest for cleft closure | Other | Autogenous bone graft group |
Primary outcome
Oro-nasal Fistula
Time frame: 6 months
it will be assessed visually and by questionnaire with binary measuring unit (present or not).• Examination of oro-nasal Fistula will be done by using the following diagnostic criteria: 1.Air escape from the opening when patient blows his/her nose. 2.An obvious communication between the opening and floor of the nasal cavity. 3.Unobstructed penetration of Guttapercha through the opening into the nasal cavity. 4.Hypernasality of voice due to audible nasal air escape during speech. 5.Nasal regurgitation of fluids. 6.Food lodgement into nasal cavity with risk of rhinitis .
2 secondary outcomes
C.T analysis of secondary bone grafts
Time frame: 6 months
Donor site long standing pain
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 12 Feb 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 Early Phase 1 study testing MPM Prepared From Allogenic Bone Graft and Autogenous bone in people with Cleft; Alveolar Process, run by Cairo University.
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 1 inclusion and 1 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 12 Feb 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
Oro-nasal Fistula (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 12 Feb 2018.