N/A N=5 Treatment

Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients

Cleft Lip and Palate

Bottom Line

View on ClinicalTrials.gov: NCT01932164 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: Primary: Amount of New Bone Mass Formed — 89 percentage of bone formation

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: maxillary alveolar graft by tissue engineering (Procedure); Bone tissue engineering using mesenchymal stem cells (Procedure)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: Hospital Sirio-Libanes
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Amount of New Bone Mass Formed	89	—
PRIMARY Quality of Bone Regeneration	90	—

Summary

The aim of this study is to perform the bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®) through prospective qualitative and quantitative analysis of bone neoformation.

Eligibility Criteria

Inclusion Criteria

Diagnosis of unilateral cleft lip and palate ;
Patient who has performed the treatment to align the dental arches in the ambulatory of odontology at Hospital Municipal Infantil Menino Jesus;
Patient that have Goslow index 1, 2 or 3;
Patiente which have 2/3 of the root of the canine tooth (cleft region) formed.

Exclusion Criteria

Prior alveolar surgery;
Canine teeth erupted before the bone graft;
Presence of co-morbidities;
Incomplete documentation;
Patients who have not done all the multidisciplinary treatment at Hospital Municipal Infantil Menino Jesus.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01932164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.