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

NCT04693741 | Unknown

• 1 other identifier: alveolar bone graft
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

this work aims to evaluate xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting.

Conditions

Alveolar Cleft

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Autogenous iliac bone graft "group A"

OTHER

The autogenous iliac bone graft will be used to fill the alveolar defect.

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.

Procedure: secondary alveolar bone graft; Procedure: Preparation of PRP

Interventions

secondary alveolar bone graft PROCEDURE

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.

Autogenous iliac bone graft "group A"; Xenograft with PRF "group B"

Harvesting of the autogenous bone graft PROCEDURE

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.

Autogenous iliac bone graft "group A"

Preparation of PRP PROCEDURE

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.

Xenograft with PRF "group B"

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 18022477 BACKGROUND

• 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.

  PMID: 15108870 BACKGROUND

• 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.

  PMID: 26792963 BACKGROUND

• 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.

  PMID: 22450004 BACKGROUND

• 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.

  PMID: 8939379 BACKGROUND

• 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.

  PMID: 29859781 BACKGROUND

Study Officials

• Mohamed Elshazly, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

• Awny asklany, doctor

  Assiut University

  PRINCIPAL INVESTIGATOR

• mohammed nahed attia, doctor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hager Bedeer, MBBS

CONTACT

+201028827948; hager_bedeer00@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: January 5, 2021
• Study Start: January 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: March 1, 2023
• Last Updated: January 5, 2021

Record last verified: 2021-01