Evaluation of Secondary Alveolar Cleft Reconstruction

Evaluation of Secondary Alveolar Cleft Reconstruction Using Bone Matrix Prepared From Cancellous Particulates Mixed With Albumin-PRF or L-PRF: (A Randomized Controlled Clinical Trial)

The rehabilitation of the disorganized maxilla is the primary objective of secondary alveolar bone grafting (SABG) for alveolar clefts, as the bony reconstruction of the discontinued maxillary arch would permit proper anterior teeth eruption, improve their orthodontic movements, restore the nasal and alar base symmetry, counteract the growth disturbance effects and seal the oronasal communication. By the time the transverse growth of the maxillary arch is nearly complete during the mixed dentition stage, (SABG) intends to bridge the maxillary continuity by a quantitative bone graft entity that minimizes the maxillary collapse and growth impairment after an appropriate separation and elevation of the nasal and mucosal flaps.

Study Overview

• Status: Completed
• Conditions: Alveolar Cleft
• Intervention / Treatment: Procedure: Alveolar Cleft Reconstruction

Detailed Description

By its ample content of subcutaneous autogenous cancellous bone particulates, the iliac crest is considered the gold standard for (SABG) of alveolar clefts, with optimal restoration of the maxillary continuity, and fair subsequent teeth eruption, orthodontic movements or implant placement. However, several studies have demonstrated that the final volume of the sole iliac crest particulate graft is unpredictable.

Sohn et al. in 2010 introduced the growth-factors enriched bone matrix "sticky bone" concept that incorporates the platelet-rich fibrin (PRF) into the particulate grafts to enhance their moldability and enrich them with three-dimensional (3D) fibrin networking scaffold and high concentrations of growth factors, which promote cell division, modulate tissue healing and induce angiogenesis, such as vascular endothelial growth factors (VEGF), recombinant human platelet-derived growth factor (rhPDGF), transforming growth factors ß-1 (TGFß-1), bone morphogenic protein-2 (rhBMP2), insulin growth factor-I (IFG-I), and epithelial growth factor (EGF), and interleukins.

During the last decade, various (PRF) preparations and centrifuge protocols have been developed, forming various platelet products with different biological constitutions and potential applications. The (PRF) evolution began with the development of the leukocyte- and platelet-rich fibrin (L-PRF) by an increased centrifuge time and speed, followed by advanced platelet-rich fibrin (A-PRF), injectable platelet-rich fibrin (I-PRF), horizontal platelet-rich fibrin (H-PRF), Concentrated PRF (C-PRF) and most recently the albumin-PRF (Albumin gel).

The (L-PRF) employs the extract of the platelet-rich plasma (PRP) in the form of a fibrin clot, meanwhile discarding the platelet-poor plasma (PPP). On the other hand, the albumin gel preparation employs the aspiration and heating of the platelet-poor plasma (PPP), the upper layer, then remixing it with the (PRP) layer and the buffy coat; the lower layers, after being allowed to cool. Although the heating and cooling process would threaten the vitality of cells and the growth factor of the (PPP) layer, this will polymerize its plasmatic proteins and denature the high albumin content as a result of the replacement of the weak hydrogen bond linkages within the protein molecule, with densely organized ones, in addition to the formation of thermal aggregate cross-linkage fibrin networks with an overall endured mechanical strength, prolonged degradation time up to 4-6months, and extended release of growth factors up to ten days.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Giza, Cairo Governorate, Egypt, 002
      • Beni-Suef University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients of both sexes with unilateral secondary maxillary alveolar cleft, during the mixed dentition stage with an age range of (eight to twelve years old)
2. Good general good health and proper state of oral hygiene.

Exclusion Criteria:

1. The detection of maxillary pathosis or palatal fistulae during the radiographic or clinical examination.
2. Patients with systemic disorders that would compromise the bone harvest or graft outcomes, those with cleft-associated syndromes or a history of previous failed (SABG)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group (L-PRF); The tubes will be centrifuged at (700 g for 12 min). By the end of the centrifuge cycle, the PRF clots will be extruded from the tubes with a sterile tweezer and separated from the underlying RBCs with sterile scissors.	Procedure: Alveolar Cleft Reconstruction; Alveolar Cleft Reconstruction Using Bone Matrix Prepared from Cancellous Particulates Mixed with Albumin-PRF in study group versus L-PRF in control group
Active Comparator: Study group (Albumin-PRF); The tubes will be centrifuged at (700 g for 8 minutes). The upper (PPR) layer will be aspirated through the unremoved plastic cap, collected in a 2-ml plastic syringe, and placed into a bio-heat device for heating at (75°C for 10 minutes) for the purpose of albumin gel formation, which will be allowed to cool for an additional ten minutes into the room temperature in a sealed dark container before being mixed with the liquid PRF and buffy coat lower layers, using a female-female luer lock connector	Procedure: Alveolar Cleft Reconstruction; Alveolar Cleft Reconstruction Using Bone Matrix Prepared from Cancellous Particulates Mixed with Albumin-PRF in study group versus L-PRF in control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The graft fill rate	The patients will be followed up immediately after surgery and then monthly during the six-month graft consolidation period. Immediate postoperative and six-month postoperative Cone beam xray will be undertaken for the patients, which will be superimposed to compare the exact extent of vertical and horizontal bone loss between the cases of the study and control groups.	6 months
The graft resorption rate	The patients will be followed up immediately after surgery and then monthly during the six-month graft consolidation period. Immediate postoperative and six-month postoperative Cone beam xray will be undertaken for the patients, which will be superimposed to compare the exact extent of vertical and horizontal bone loss between the cases of the study and control groups.	6 months
The bone bridge formation rate	The patients will be followed up immediately after surgery and then monthly during the six-month graft consolidation period. Immediate postoperative and six-month postoperative Cone beam xray will be undertaken for the patients, which will be superimposed to compare the exact extent of vertical and horizontal bone loss between the cases of the study and control groups.	6 months
Bone bridge density values:	The patients will be followed up immediately after surgery and then monthly during the six-month graft consolidation period. Immediate postoperative and six-month postoperative Cone beam xray will be undertaken for the patients, which will be superimposed to compare the exact extent of vertical and horizontal bone loss between the cases of the study and control groups.	6 months

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): November 14, 2025

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 23 (SIME)

Drug and device information, study documents

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