Evaluation of Secondary Alveolar Cleft Reconstruction

NCT06621719 | Completed

• 1 other identifier: 23
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alveolar Cleft

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Control group (L-PRF)

ACTIVE COMPARATOR

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

Study group (Albumin-PRF)

ACTIVE COMPARATOR

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

Interventions

Alveolar Cleft Reconstruction PROCEDURE

Alveolar Cleft Reconstruction Using Bone Matrix Prepared from Cancellous Particulates Mixed with Albumin-PRF in study group versus L-PRF in control group

Control group (L-PRF); Study group (Albumin-PRF)

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• Good general good health and proper state of oral hygiene.

You may not qualify if:

• The detection of maxillary pathosis or palatal fistulae during the radiographic or clinical examination.
• 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)

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University

Giza, Cairo Governorate, 002, Egypt

Location

Study Design

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

Model Details: This clinical trial introduces a radiographic volumetric and bone density comparison of alveolar clefts obliterated with "sticky bone," prepared by mixing iliac crest cancellous bone particulates with either L-PRF (Control group) or Albumin-PRF (Study group).

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 1, 2024
• Study Start: November 7, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 14, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

EG (1)