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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Hospital Sirio-Libanes
Sponsor:
Collaborator:
Hospital Municipal Infantil Menino Jesus
Information provided by (Responsible Party):
Daniela Franco Bueno, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier:
NCT01932164
First received: August 27, 2013
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Cleft Lip and Palate
Procedure: maxillary alveolar graft by tissue engineering

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients

Resource links provided by NLM:


Further study details as provided by Hospital Sirio-Libanes:

Primary Outcome Measures:
  • Amount of new bone mass formed [ Time Frame: 3 months from surgical procedure for alveolar grafting; ] [ Designated as safety issue: Yes ]
    The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 months from surgical procedure of tissue engineering.

  • Quality of bone regeneration [ Time Frame: Three months after the graft ] [ Designated as safety issue: Yes ]
    The quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques.


Estimated Enrollment: 5
Study Start Date: May 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cleft lip and palate
Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment
Procedure: maxillary alveolar graft by tissue engineering
Extraction of deciduous tooth to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth associated with a biomaterial composed of collagen and hydroxyapatite.
Other Names:
  • alveolar bone graft
  • bone tissue engineering
  • bone tissue engineering using mesenchymal stem cells

Detailed Description:

The reconstruction of the craniofacial skeleton in development between 2 and 10 years old, remains a major challenge for reconstructive plastic surgery. Local autogenous bone is practically unavailable, the distant bone graft has significant morbidity and use of alloplastic materials is incompatible with the growing facial skeleton. With the advent of bioengineered tissue, however, osteogenesis induced by the use of mesenchymal stem cells associated with biomaterials has become a potential solution to the shortage bone-related morbidity and donor bone in the region in pediatric patients.

The association of mesenchymal stem cells to biomaterials has provided new bone formation and a significant reduction of morbidity, for rehabilitation of the alveolar bone in patients with cleft lip palate.

To perform the rehabilitation of alveolar bone cleft, other donor regions of bone (iliac crest, ribs, skull) suffer morbidity for obtaining bone to be used in alveolar bone grafting. In order to eliminate the morbidity at the bone donor region for these patients and reduce costs of patient permanence in the operating room 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

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932164

Contacts
Contact: Daniela F Bueno, DDS, PhD 55 11 3155 0200 ext 3753 dbuenousp@gmail.com
Contact: Mariana MS Santos 55 11 3155 0200 ext 0267 apoioaopesquisador@hsl.org.br

Locations
Brazil
Hospital Sírio Libanês Recruiting
São Paulo, Brazil, 01308-060
Contact: Daniela F Bueno, PhD    55 11 3155 0200 ext 3753    dbuenousp@gmail.com   
Contact: Mariana MS Santos    55 11 3155 0200 ext 0267    apoioaopesquisador@hsl.org.br   
Principal Investigator: Daniela F Bueno, PhD         
Sponsors and Collaborators
Hospital Sirio-Libanes
Hospital Municipal Infantil Menino Jesus
Investigators
Principal Investigator: Daniela F Bueno, PhD Hospital Sírio Libanês
  More Information

Publications:
Responsible Party: Daniela Franco Bueno, DDS; PhD, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier: NCT01932164     History of Changes
Other Study ID Numbers: HSL 2013-04
Study First Received: August 27, 2013
Last Updated: August 30, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Sirio-Libanes:
Cleft lip and palate
Deciduous dental pulp stem cells
mesenchymal stem cells
tissue engineering
bone tissue engineering
bioengineering

Additional relevant MeSH terms:
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 26, 2014