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

Alveolar Cleft Clinical Trial

Official title:

Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting: A Comparative Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04693741
• Other study ID #: alveolar bone graft
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: March 2023

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: Hager Bedeer, MBBS
• Phone: +201028827948
• Email: hager_bedeer00[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: March 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Cleft

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Kamal M, Ziyab AH, Bartella A, Mitchell D, Al-Asfour A, Hölzle 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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