Alveolar CleftNCT04693741
Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting
A study testing secondary alveolar bone graft, Harvesting of the autogenous bone graft and Preparation of PRP in people with Alveolar Cleft, run by Assiut University.
Trial summary
this work aims to evaluate xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting. 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?
- secondary alveolar bone graft, Harvesting of the autogenous bone graft and Preparation of PRP
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age (7 - 12 years).
- Non-syndromic CLA or CLP.
- More than 6 months of follow-up.
Who cannot join
- History of previous alveolar surgery.
- History of active infection or underlying diseases such as hematologic disorders, neoplasm, and immune deficiency
- Patients who had received primary or tertiary ABG.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting: A Comparative Clinical Study
this work aims to evaluate xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting.
Read the detailed description
The alveolar cleft is a maxillary bone defect resulting from incomplete fusion of the medial nasal process (MNP) and maxillary process (MXP) during embryonic development. Alveoloplasty may be classified as primary, secondary, and tertiary depending on the age of the patient. Literature defines primary when the alveoloplasty is performed at the same time as soft tissue repair. If performed at the age of 8 to 9 years before the eruption of the permanent canine, it is classified as secondary; it is classified as late secondary or tertiary if performed in the elderly. For patients with cleft lip and palate, secondary alveolar bone grafting (SABG) of the cleft alveolar ridge is performed when the patient has mixed dentition; SABG is a procedure that aims to create a bony bridge that restores dental arch continuity, repair the oronasal fistula, provide support to the structure of the alar base, facilitate subsequent orthodontic treatment, and promote tooth eruption. Autologous bone grafting is the gold standard for treating alveolar clefts, with the iliac crest bone being the most widely accepted donor site. Other materials such as growth factors, combinations of improved scaffolds and cell treatment/growth factors, biocomposites, and hemostatic agents can be used to regenerate bone and have been the subjects of intensive research.
- Conditions
- Alveolar Cleft
- Being tested
- secondary alveolar bone graft, Harvesting of the autogenous bone graft, Preparation of PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secondary alveolar bone graftProcedure or surgery
Under general anesthesia, the soft tissue in the gingiva surrounding the alveolar cleft will be injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. At the alveolar cleft site, gingival sulcus incisions will be made on both sides of the cleft. The tissue will then elevated beneath the periosteum. The mucosa of the nasal floor and the oral mucosa will be dissected. Next, the bone particles will be implanted into the bone defect.
Then, The cleft site will be closed without tension by the advancement of the gingival flaps.
Harvesting of the autogenous bone graftProcedure or surgery
Under general anaesthesia ,the soft tissue in the superior iliac crest will injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. The cancellous bone will harvested with an osteotome and then cut into small bone granules.
Preparation of PRPProcedure or surgery
10 ml of blood will be collected in vacuum tubes without anticoagulants which are then immediately centrifuged at a rate of 3000 rpm for 10 min. After centrifugation, the resultant product consists of three layers. The topmost layer consisting of acellular PPP (platelet poor plasma), PRF clot in the middle and RBCs at the bottom of the test tube. The attached red blood cells scraped off from it and discarded. The discarded PRF is then mixed with xenograft and placed inside the alveolar defect.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous iliac bone graft "group A" | Other | The autogenous iliac bone graft will be used to fill the alveolar defect. Receives: Procedure: secondary alveolar bone graft; Procedure: Harvesting of the autogenous bone graft |
| Xenograft with PRF "group B" | Other | Xenograft with PRF will be used to fill the alveolar defect. Receives: Procedure: secondary alveolar bone graft; Procedure: Preparation of PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring of bone volume 6 months post-operative.
Compare between outcome of xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting regarding the newly formed bone volume.
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 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alveolar CleftStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into two groups according to the surgical procedure performed as follows: Group A: the autogenous iliac bone graft will be used to fill the alveolar defect. Group B : Xenograft with PRF will be used to fill the alveolar defect.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Montaser Sayed Bedeer, Assiut University
- Investigators
- Mohamed Elshazly, professor, Principal investigator, Assiut UniversityAwny asklany, doctor, Principal investigator, Assiut Universitymohammed nahed attia, doctor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693741
- Sponsor's protocol ID
- alveolar bone graft
- Status last verified
- Jan 2021
- First submitted
- 27 Oct 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moreau JL, Caccamese JF, Coletti DP, Sauk JJ, Fisher JP. Tissue engineering solutions for cleft palates. J Oral Maxillofac Surg. 2007 Dec;65(12):2503-11. doi: 10.1016/j.joms.2007.06.648.
PubMed 18022477Schnitt DE, Agir H, David DJ. From birth to maturity: a group of patients who have completed their protocol management. Part I. Unilateral cleft lip and palate. Plast Reconstr Surg. 2004 Mar;113(3):805-17. doi: 10.1097/01.prs.0000105332.57124.89.
PubMed 15108870Seifeldin SA. Is alveolar cleft reconstruction still controversial? (Review of literature). Saudi Dent J. 2016 Jan;28(1):3-11. doi: 10.1016/j.sdentj.2015.01.006. Epub 2015 Jun 25.
PubMed 26792963Seike T, Hashimoto I, Matsumoto K, Tanaka E, Nakanishi H. Early postoperative evaluation of secondary bone grafting into the alveolar cleft and its effects on subsequent orthodontic treatment. J Med Invest. 2012;59(1-2):152-65. doi: 10.2152/jmi.59.152.
PubMed 22450004Tan AE, Brogan WF, McComb HK, Henry PJ. Secondary alveolar bone grafting--five-year periodontal and radiographic evaluation in 100 consecutive cases. Cleft Palate Craniofac J. 1996 Nov;33(6):513-8. doi: 10.1597/1545-1569_1996_033_0513_sabgfy_2.3.co_2.
PubMed 8939379Kamal M, Ziyab AH, Bartella A, Mitchell D, Al-Asfour A, Holzle F, Kessler P, Lethaus B. Volumetric comparison of autogenous bone and tissue-engineered bone replacement materials in alveolar cleft repair: a systematic review and meta-analysis. Br J Oral Maxillofac Surg. 2018 Jul;56(6):453-462. doi: 10.1016/j.bjoms.2018.05.007. Epub 2018 May 30.
PubMed 29859781
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting: A Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT04693741
- Acronym / sponsor ID
- alveolar bone graft
- Conditions
- Alveolar Cleft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 5 Jan 2021 (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 work aims to evaluate xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting.
Detailed description
The alveolar cleft is a maxillary bone defect resulting from incomplete fusion of the medial nasal process (MNP) and maxillary process (MXP) during embryonic development. Alveoloplasty may be classified as primary, secondary, and tertiary depending on the age of the patient. Literature defines primary when the alveoloplasty is performed at the same time as soft tissue repair. If performed at the age of 8 to 9 years before the eruption of the permanent canine, it is classified as secondary; it is classified as late secondary or tertiary if performed in the elderly. For patients with cleft lip and palate, secondary alveolar bone grafting (SABG) of the cleft alveolar ridge is performed when the patient has mixed dentition; SABG is a procedure that aims to create a bony bridge that restores dental arch continuity, repair the oronasal fistula, provide support to the structure of the alar base, facilitate subsequent orthodontic treatment, and promote tooth eruption. Autologous bone grafting is the gold standard for treating alveolar clefts, with the iliac crest bone being the most widely accepted donor site. Other materials such as growth factors, combinations of improved scaffolds and cell treatment/growth factors, biocomposites, and hemostatic agents can be used to regenerate bone and have been the subjects of intensive research.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized into two groups according to the surgical procedure performed as follows: Group A: the autogenous iliac bone graft will be used to fill the alveolar defect. Group B : Xenograft with PRF will be used to fill the alveolar defect.
| Arm | Type | Receives |
|---|---|---|
| Autogenous iliac bone graft "group A" | Other | Procedure: secondary alveolar bone graft, Procedure: Harvesting of the autogenous bone graftThe autogenous iliac bone graft will be used to fill the alveolar defect. |
| Xenograft with PRF "group B" | Other | Procedure: secondary alveolar bone graft, Procedure: Preparation of PRPXenograft with PRF will be used to fill the alveolar defect. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age (7 - 12 years).
- Non-syndromic CLA or CLP.
- More than 6 months of follow-up.
Key exclusion criteria (3 listed)
- History of previous alveolar surgery.
- History of active infection or underlying diseases such as hematologic disorders, neoplasm, and immune deficiency
- Patients who had received primary or tertiary ABG.
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 |
|---|---|---|
| secondary alveolar bone graftUnder general anesthesia, the soft tissue in the gingiva surrounding the alveolar cleft will be injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. At the alveolar cleft site, gingival sulcus incisions will be made on both sides of the cleft. The tissue will then elevated beneath the periosteum. The mucosa of the nasal floor and the oral mucosa will be dissected. Next, the bone particles will be implanted into the bone defect. Then, The cleft site will be closed without tension by the advancement of the gingival flaps. | Procedure or surgery | Autogenous iliac bone graft "group A", Xenograft with PRF "group B" |
| Harvesting of the autogenous bone graftUnder general anaesthesia ,the soft tissue in the superior iliac crest will injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. The cancellous bone will harvested with an osteotome and then cut into small bone granules. | Procedure or surgery | Autogenous iliac bone graft "group A" |
| Preparation of PRP10 ml of blood will be collected in vacuum tubes without anticoagulants which are then immediately centrifuged at a rate of 3000 rpm for 10 min. After centrifugation, the resultant product consists of three layers. The topmost layer consisting of acellular PPP (platelet poor plasma), PRF clot in the middle and RBCs at the bottom of the test tube. The attached red blood cells scraped off from it and discarded. The discarded PRF is then mixed with xenograft and placed inside the alveolar defect. | Procedure or surgery | Xenograft with PRF "group B" |
Primary outcome
measuring of bone volume 6 months post-operative.
Time frame: 6 months
Compare between outcome of xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting regarding the newly formed bone volume.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Background: PubMed 18022477Moreau JL, Caccamese JF, Coletti DP, Sauk JJ, Fisher JP. Tissue engineering solutions for cleft palates. J Oral Maxillofac Surg. 2007 Dec;65(12):2503-11. doi: 10.1016/j.joms.2007.06.648.
- Background: PubMed 15108870Schnitt DE, Agir H, David DJ. From birth to maturity: a group of patients who have completed their protocol management. Part I. Unilateral cleft lip and palate. Plast Reconstr Surg. 2004 Mar;113(3):805-17. doi: 10.1097/01.prs.0000105332.57124.89.
- Background: PubMed 26792963Seifeldin SA. Is alveolar cleft reconstruction still controversial? (Review of literature). Saudi Dent J. 2016 Jan;28(1):3-11. doi: 10.1016/j.sdentj.2015.01.006. Epub 2015 Jun 25.
- Background: PubMed 22450004Seike T, Hashimoto I, Matsumoto K, Tanaka E, Nakanishi H. Early postoperative evaluation of secondary bone grafting into the alveolar cleft and its effects on subsequent orthodontic treatment. J Med Invest. 2012;59(1-2):152-65. doi: 10.2152/jmi.59.152.
- Background: PubMed 8939379Tan AE, Brogan WF, McComb HK, Henry PJ. Secondary alveolar bone grafting--five-year periodontal and radiographic evaluation in 100 consecutive cases. Cleft Palate Craniofac J. 1996 Nov;33(6):513-8. doi: 10.1597/1545-1569_1996_033_0513_sabgfy_2.3.co_2.
- Background: PubMed 29859781Kamal M, Ziyab AH, Bartella A, Mitchell D, Al-Asfour A, Holzle F, Kessler P, Lethaus B. Volumetric comparison of autogenous bone and tissue-engineered bone replacement materials in alveolar cleft repair: a systematic review and meta-analysis. Br J Oral Maxillofac Surg. 2018 Jul;56(6):453-462. doi: 10.1016/j.bjoms.2018.05.007. Epub 2018 May 30.
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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.
Mohamed Elshazly, professor principal investigator
Assiut University
Awny asklany, doctor principal investigator
Assiut University
mohammed nahed attia, doctor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing secondary alveolar bone graft, Harvesting of the autogenous bone graft and Preparation of PRP in people with Alveolar Cleft, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. 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.
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 Hager Bedeer, MBBS (+201028827948, hager_bedeer00@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring of bone volume 6 months post-operative. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04693741, which also lists 6 linked publications.
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 5 Jan 2021.