Alveolar Cleft Reconstruction Powered by - Trial NCT04886947

Timeline & Enrollment

Primary Outcome

Alveolar bone density,Alveolar bone volume

Summary

More than four million children are born with birth defects worldwide every year and a
 million presenting with cleft lip and palate. Cleft lip and palate is a congenital defect of
 the lip alveolar and palate it's now recognized as a significant cause of infant mortality
 and childhood morbidity and included among global burden of disease initiative. In Uganda the
 estimated number of babies born with cleft lip and palate is 1100 per year Children with 75%
 of them having alveolar cleft which is a defect in the upper jaw (Maxilla arch).
 
 The secondary bone graft and gingivoperiosteoplasty have become the two popular approaches to
 bone generation in alveolar defect. These two methods have varying success rates; primary
 gingivoperiosteoplasty 50 to 60% and secondary bone graft is 87% but Gingivoperiosteoplasty
 is the preferred option to many African surgeons to obviate the need for bone grafting which
 is technically demanding, prolonging therapy with many procedures therefore poor compliance,
 also increasing treatment failure rate and has significant associated donor morbidity. This
 project is set out to address the challenge of bone regeneration in alveolar cleft and
 improve on the surgical outcome by the use of stem cell therapy.
 
 The objective of this study is to compare the outcome of umbilical cord blood stem cell
 transplant plus gingivoperiosteoplasty to conventional gingivoperiosteoplasty on timing and
 density of bone regeneration.
 
 1.3. Hypothesis In this study we hypothesize that primary repair with gingivoperiosteoplasty
 the success rate can be improved or enhanced with the use of stem cell therapy in our
 setting.
 
 Alternative hypothesis: Autologous umbilical stem cells transplantation following
 gingivoperiosteoplasty results in better bone regeneration when compared to
 gingivoperiosteoplasty.
 
 Null hypothesis: Autologous umbilical stem cells transplantation following
 gingivoperiosteoplasty has no benefit on promoting bone regeneration when compared to
 gingivoperiosteoplasty alone.
 
 The study will be a case control pilot study conducted in Kiruddu National Referral hospital
 Kampala Uganda. 20 participants who will be neonates of either sex with unilateral cleft lip
 and palate will be recruited in the study. They will be split into two groups: group A will
 have the umbilicus cord and placenta blood collected at birth and group B will not have
 umbilical cord or placenta blood collected and will be designated as the Control group.

ICD-10 Classifications