Clinical trial NCT04693741: Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting
Official title: Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting: A Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Cleft
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 36
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Age (7 - 12 years).
* Non-syndromic CLA or CLP.
* More than 6 months of follow-up.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: measuring of bone volume 6 months post-operative.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed Elshazly, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Awny asklany, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: mohammed nahed attia, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Schnitt 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.
citation: Seifeldin 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.
citation: Seike 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.
citation: Tan 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.
citation: Kamal 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.