Alveolar CleftNCT05988086
Double Closure of Nasal Layer in Alveolar Cleft Grafting
A study testing platelet rich fibrin and collagen membrane in people with Alveolar Cleft, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this prospective study is to evaluate both clinically and radiologically the efficacy of using autologous platelets rich fibrin versus collagen membrane for nasal layer closure in secondary alveolar cleft repair. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Cleft
- What is being tested?
- platelet rich fibrin and collagen membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2022to 30 Sep 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patients with unilateral alveolar cleft
- the patient's permenant canines either not or partially erupted
- medically free patients
Who cannot join
- patients with bilateral alveolar cleft
- medically compromised patients
- Any associated craniofacial syndromes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Using Platelet Rich Fibrin Versus Collagen Membrane for Enhancing Healing of Secondary Grafted Alveolar Cleft
The aim of this prospective study is to evaluate both clinically and radiologically the efficacy of using autologous platelets rich fibrin versus collagen membrane for nasal layer closure in secondary alveolar cleft repair.
Read the detailed description
Patients and methods: Twenty-four patients with alveolar clefts will be included in this study. The patients will be evaluated with age ranging between (7 - 12) years. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
The selected children should possess the following criteria: Their permanent canines either not or partially erupted, has no systemic disorder which can affect the grafting outcome and healing process such as juvenile diabetes mellitus, kidney, liver, or blood diseases and has no associated craniofacial syndromes. The patients will be classified into two groups according to incorporation of autologous platelet rich fibrin or collagen membrane for nasal layer closure with the grafting material, as follow: Group 1: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone. Group 2: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.
Preoperative evaluation of alveolar cleft site:
all patients will be examined clinically and radiologically. Clinical examination: This will consider the stability of maxillary segments, presence of old scar, asymmetry of the alar base, presence of oronasal fistula, and the presence of erupting teeth in the cleft.
Radiological examination: Panoramic radiographs will be done for each patient and examined as regard: the morphology of the cleft area, the size of the cleft side, the presence or absence of permanent lateral incisor and canine, the development of root length, and stage of eruption of permanent canine and lateral incisor. In addition, Axial computed tomography (CT) scans will be done for each patient to assess and measure local bone mineral density of grafted alveolar bone cleft.
Postoperative evaluation of the grafted site:
The grafted site will be evaluated clinically for healing condition at the follow up periods (1st week, then 1st , 3rd ,6th ,and 9th month postoperatively) ; regarding the presence of inflammation or infection , the soft tissue scar overlying the bone graft , tenderness of bone graft site , recurrence of oronasal fistula , alveolar ridge contour in cleft region and eruption of cleft related teeth . Radiological evaluation will be done for each patient using Axial computed tomography (CT) scans at the follow up period (3rd and 9th month postoperatively) to assess and measure local bone mineral density.
- Conditions
- Alveolar Cleft
- Being tested
- platelet rich fibrin, collagen membrane
- Keywords
- alveolar cleft, collagen membrane, 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
12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone.
collagen membraneProcedure or surgery
12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: platelet rich fibrin | Active comparator | Group 1: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone. Receives: Procedure: platelet rich fibrin |
| Group 2:collagen membrane | Active comparator | Group 2: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone. Receives: Procedure: collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
0 representing no pain and 10 representing the highest level of pain
Measured: 1 month
inflammation score scale
0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
Measured: 1 month
density of bone
density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU
Measured: 1 month
Secondary outcomes (1)
bone mineral density.
density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start10 Oct 2022
- Primary completion10 Mar 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar CleftStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Taha Ibrahim, Tanta University
- Investigators
- Marwa T Ibrahim, lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988086
- Sponsor's protocol ID
- R-OS-9-22-1
- Status last verified
- Nov 2023
- First submitted
- 20 Jul 2023
- Last updated
- 21 Nov 2023
- 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Using Platelet Rich Fibrin Versus Collagen Membrane for Enhancing Healing of Secondary Grafted Alveolar Cleft
- ClinicalTrials.gov ID
- NCT05988086
- Acronym / sponsor ID
- R-OS-9-22-1
- Conditions
- Alveolar Cleft
- Keywords
- alveolar cleft, collagen membrane, platelet rich fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 14 Aug 2023 (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 prospective study is to evaluate both clinically and radiologically the efficacy of using autologous platelets rich fibrin versus collagen membrane for nasal layer closure in secondary alveolar cleft repair.
Detailed description
Patients and methods: Twenty-four patients with alveolar clefts will be included in this study. The patients will be evaluated with age ranging between (7 - 12) years. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
The selected children should possess the following criteria: Their permanent canines either not or partially erupted, has no systemic disorder which can affect the grafting outcome and healing process such as juvenile diabetes mellitus, kidney, liver, or blood diseases and has no associated craniofacial syndromes. The patients will be classified into two groups according to incorporation of autologous platelet rich fibrin or collagen membrane for nasal layer closure with the grafting material, as follow: Group 1: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone. Group 2: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.
Preoperative evaluation of alveolar cleft site:
all patients will be examined clinically and radiologically. Clinical examination: This will consider the stability of maxillary segments, presence of old scar, asymmetry of the alar base, presence of oronasal fistula, and the presence of erupting teeth in the cleft.
Radiological examination: Panoramic radiographs will be done for each patient and examined as regard: the morphology of the cleft area, the size of the cleft side, the presence or absence of permanent lateral incisor and canine, the development of root length, and stage of eruption of permanent canine and lateral incisor. In addition, Axial computed tomography (CT) scans will be done for each patient to assess and measure local bone mineral density of grafted alveolar bone cleft.
Postoperative evaluation of the grafted site:
The grafted site will be evaluated clinically for healing condition at the follow up periods (1st week, then 1st , 3rd ,6th ,and 9th month postoperatively) ; regarding the presence of inflammation or infection , the soft tissue scar overlying the bone graft , tenderness of bone graft site , recurrence of oronasal fistula , alveolar ridge contour in cleft region and eruption of cleft related teeth . Radiological evaluation will be done for each patient using Axial computed tomography (CT) scans at the follow up period (3rd and 9th month postoperatively) to assess and measure local bone mineral density.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: platelet rich fibrin | Active comparator | Procedure: platelet rich fibrinGroup 1: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone. |
| Group 2:collagen membrane | Active comparator | Procedure: collagen membraneGroup 2: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients with unilateral alveolar cleft
- the patient's permenant canines either not or partially erupted
- medically free patients
Key exclusion criteria (3 listed)
- patients with bilateral alveolar cleft
- medically compromised patients
- Any associated craniofacial syndromes.
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 fibrin12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone. | Procedure or surgery | Group 1: platelet rich fibrin |
| collagen membrane12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone. | Procedure or surgery | Group 2:collagen membrane |
Primary outcome
visual analogue scale
Time frame: 1 month
0 representing no pain and 10 representing the highest level of pain
inflammation score scale
Time frame: 1 month
0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
density of bone
Time frame: 1 month
density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU
1 secondary outcome
bone mineral density.
Time frame: 9 months
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 21 Nov 2023.
- 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.
Marwa T Ibrahim, lecturer principal investigator
Tanta University
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 and collagen membrane in people with Alveolar Cleft, run by Tanta 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 3 inclusion and 3 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 21 Nov 2023. 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?
visual analogue scale (time frame: 1 month). 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 21 Nov 2023.