Cleft Lip and Palate Clinical Trial
— CLOSEOfficial title:
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Verified date | May 2020 |
Source | Hospital Sirio-Libanes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Iliac crest autogenous bone graft is accepted as the most effective method for secondary alveolar cleft repair. However this method is associated with complications. As an alternative, mesenchymal stem cells associated with biomaterials have been used for the rehabilitation of the alveolar bone cleft of patients with cleft lip and palate. This is a RCT comparing mesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials versus iliac crest autogenous bone graft for secondary alveolar cleft repair.
Status | Completed |
Enrollment | 62 |
Est. completion date | December 15, 2019 |
Est. primary completion date | December 6, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 12 Years |
Eligibility |
Inclusion Criteria: - non syndromic unilateral cleft lip and palate; - age between 7 and 12 years; - to have the jaw aligned and ready to receive the graft. Exclusion Criteria: - previous surgery to correct the alveolar cleft; - have the canine erupted before grafting; - incomplete orthodontic treatment; - incomplete CT scan documentation. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Sírio-Libanes | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital Sirio-Libanes | Ministry of Health, Brazil |
Brazil,
Pinheiro CCG, Leyendecker Junior A, Tanikawa DYS, Ferreira JRM, Jarrahy R, Bueno DF. Is There a Noninvasive Source of MSCs Isolated with GMP Methods with Better Osteogenic Potential? Stem Cells Int. 2019 Nov 6;2019:7951696. doi: 10.1155/2019/7951696. eCollection 2019. — View Citation
Tanikawa 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alveolar bone filling rate | Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area. | 12 months | |
Primary | Serious adverse events | Serious adverse events resulting in death, life-threatening event, hospitalization, prolongation of existing hospitalization (for > 24 hours), persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Important medical event that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon medical judgment, it may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Frequency of participants experiencing at least one serious adverse event. |
12 months | |
Secondary | Non serious adverse events | Frequency of participants experiencing at least one non serious adverse event | 15 days; 3, 6 and 12 months | |
Secondary | Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair | Bone tissue engineering | ||
Secondary | Position of the canine tooth and formation of dental root | Position of the canine tooth and formation of dental root assessed by CT scan | 12 months | |
Secondary | Alveolar bone filling rate | Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area. | 6 months | |
Secondary | Serious adverse events | Serious adverse events resulting in death, life-threatening event, hospitalization, prolongation of existing hospitalization (for > 24 hours), persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Important medical event that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon medical judgment, it may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Frequency of participants experiencing at least one serious adverse event. |
15 days; 3 and 6 months | |
Secondary | Patient-reported outcome (PRO, including appearance, fuction and quality of life) | Assessed by CLEFT-Q, a self-report PRO instrument, tool answered independently patients themselves, without interpretation by the parent(s) or healthcare provider. The CLEFT-Q consists of 13 independently functioning domains (171 items) measuring appearance, facial function and quality of life. Each domain is composed of a series of items that together evaluate a unidimensional construct. A higher score means a better result (continuous outcome, measured by: mean) | pre surgery and 12 months |
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