Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
1 other identifier
interventional
5
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 27, 2013
CompletedFirst Posted
Study publicly available on registry
August 30, 2013
CompletedResults Posted
Study results publicly available
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2015
CompletedMay 28, 2020
May 1, 2020
2.6 years
August 27, 2013
March 18, 2015
May 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Amount of New Bone Mass Formed
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 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.
6 months from surgical procedure for alveolar grafting;
Quality of Bone Regeneration
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. We are waiting the canine eruption at the mouth.
Three months after the graft
Study Arms (1)
cleft lip and palate
EXPERIMENTAL5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery
Interventions
Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;
Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Sírio Libanês
São Paulo, 01308-060, Brazil
Related Publications (3)
Hibi H, Yamada Y, Ueda M, Endo Y. Alveolar cleft osteoplasty using tissue-engineered osteogenic material. Int J Oral Maxillofac Surg. 2006 Jun;35(6):551-5. doi: 10.1016/j.ijom.2005.12.007. Epub 2006 Apr 11.
PMID: 16584868BACKGROUNDGimbel M, Ashley RK, Sisodia M, Gabbay JS, Wasson KL, Heller J, Wilson L, Kawamoto HK, Bradley JP. Repair of alveolar cleft defects: reduced morbidity with bone marrow stem cells in a resorbable matrix. J Craniofac Surg. 2007 Jul;18(4):895-901. doi: 10.1097/scs.0b013e3180a771af.
PMID: 17667684BACKGROUNDTanikawa DYS, Pinheiro CCG, Almeida MCA, Oliveira CRGCM, Coudry RA, Rocha DL, Bueno DF. Deciduous Dental Pulp Stem Cells for Maxillary Alveolar Reconstruction in Cleft Lip and Palate Patients. Stem Cells Int. 2020 Mar 12;2020:6234167. doi: 10.1155/2020/6234167. eCollection 2020.
PMID: 32256610DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dra Daniela Franco Bueno
- Organization
- Hospital Sirio Libanes
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela F Bueno, PhD
Hospital Sírio-Libanês
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS; PhD
Study Record Dates
First Submitted
August 27, 2013
First Posted
August 30, 2013
Study Start
May 1, 2013
Primary Completion
December 16, 2015
Study Completion
December 16, 2015
Last Updated
May 28, 2020
Results First Posted
March 30, 2015
Record last verified: 2020-05