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A randomized clinical trail on effectiveness of Plasma Rich in Growth Factors (PRGF) in combination with iliac autogenous bone graft versus PRGF with Demineralized Bone Matrix ( DBM) in repairing of alveolar clefts

A randomized clinical trail on effectiveness of Plasma Rich in Growth Factors (PRGF) in combination with iliac autogenous bone graft versus PRGF with Demineralized Bone Matrix ( DBM) in repairing of alveolar clefts

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138801161790N1
Enrollment
32
Registered
2010-12-04
Start date
2008-05-04
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Repair of alveolar cleft in lip and palatal cleft patients. Cleft hard and soft palate with unilateral cleft lip

Interventions

Intervention 1: Application of DBM in combination with PRGF in Alveolar cleft grafting (Intervention group). Intervention 2: Application of autogenous Illiac crest bone in combination with PRGF in Alv
Treatment - Other
Application of DBM in combination with PRGF in Alveolar cleft grafting (Intervention group)
Application of autogenous Illiac crest bone in combination with PRGF in Alveolar cleft grafting (control group)

Sponsors

Vice chancellor for research of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 30 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) Presence of unilateral alveolar cleft in lip and palate cleft patients, 2) The age range of 8 to 30 years, Exclusion criteria: 1) Systemic disease or congenital syndrome 2) Patients who have previously had the same operation

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Formation of bony bridge in alveolar cleft. Timepoint: 6 month. Method of measurement: Measuring of bony bridge volume in alveolar cleft in ct scan.

Secondary

MeasureTime frame
Determining volume of bone formation. Timepoint: 6 month. Method of measurement: measuring of volume of grafted bone by ct scan.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amir Jalal Abbasi

Dental Faculty of Tehran University of Medical Sciences

jabbasi@razi.tums.ac.ir+98 21 8490 2131

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026