Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting

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.

Study Overview

• Status: Unknown
• Conditions: Alveolar Cleft
• Intervention / Treatment: Procedure: secondary alveolar bone graft; Procedure: Harvesting of the autogenous bone graft; Procedure: Preparation of PRP

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hager Bedeer, MBBS; Phone Number: +201028827948; Email: hager_bedeer00@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Autogenous iliac bone graft "group A"; The autogenous iliac bone graft will be used to fill the alveolar defect.	Procedure: secondary alveolar bone graft; 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.; Procedure: Harvesting of the autogenous bone graft; 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.
Other: Xenograft with PRF "group B"; Xenograft with PRF will be used to fill the alveolar defect.	Procedure: secondary alveolar bone graft; 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.; Procedure: Preparation of PRP; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Mohamed Elshazly, professor, Assiut University; Principal Investigator: Awny asklany, doctor, Assiut University; Principal Investigator: mohammed nahed attia, doctor, Assiut University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 3, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: alveolar bone graft

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No