N/A
Completed N=5
Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
Source: ClinicalTrials.gov NCT01932164 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Amount of New Bone Mass Formed — 89 percentage of bone formation
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of New Bone Mass Formed |
89 | — |
| PRIMARY Quality of Bone Regeneration |
90 | — |
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.
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. Informational only — not medical advice.