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Trial record 36 of 106 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Transplantation"

Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair (CLOSE)

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ClinicalTrials.gov Identifier: NCT03766217
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Daniela Franco Bueno, Hospital Sirio-Libanes

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cleft Lip and Palate Combination Product: Mesenchymal stem cells associated with biomaterials Combination Product: Iliac crest autogenous bone graft Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mesenchymal stem cells associated with biomaterials
Mesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials. The stem cells will be obtained by enzimatic digestion in GMP laboratory and will be seed into the biomaterial (hydroxyapatite/collagen).
Combination Product: Mesenchymal stem cells associated with biomaterials
Deciduous dental pulp mesenchymal stem cells associated with hydroxyapatita/collagen.

Active Comparator: Iliac crest autogenous bone graft
Autogenous bone will be obtained from iliac crest. The prepare of the receptor area will be the same in both arms and will follow current recommendations.
Combination Product: Iliac crest autogenous bone graft
Autogenous bone will be obtained from iliac crest.




Primary Outcome Measures :
  1. Alveolar bone filling rate [ Time Frame: 12 months ]
    Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.

  2. Serious adverse events [ Time Frame: 12 months ]

    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.



Secondary Outcome Measures :
  1. Non serious adverse events [ Time Frame: 15 days; 3, 6 and 12 months ]
    Frequency of participants experiencing at least one non serious adverse event

  2. Health-related quality of life [ Time Frame: 6 and 12 months ]
    Health-related quality of life measured by the Youth Quality of Life Facial Differences - YQOL-FD. It consists of 56 item both contextual (i.e., can be reported by others) and perceptual (i.e., known only to the youth themselves). The YQOL scores are transformed to a 0-100 scale and higher scores indicating better QoL. (continuous outcome, maesured by: mean)

  3. Position of the canine tooth and formation of dental root [ Time Frame: 12 months ]
    Position of the canine tooth and formation of dental root assessed by CT scan

  4. Alveolar bone filling rate [ Time Frame: 6 months ]
    Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.

  5. Serious adverse events [ Time Frame: 15 days; 3 and 6 months ]

    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.


  6. Patient-reported outcome (PRO, including appearance, fuction and quality of life) [ Time Frame: 6 and 12 months ]
    Assessed by CLEFT-Q, a self-report PRO instrument, tool answered independently by 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)



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766217


Contacts
Contact: Daniela F Bueno, DDS, Ph.D +55 11 33944195 dbuenousp@gmail.com
Contact: Daniela F Bueno, DDS, Ph.D +55 11 33944195 daniela.fbueno@icloud.com

Locations
Brazil
Hospital Sírio-Libanes
São Paulo, Brazil, 01308-050
Sponsors and Collaborators
Hospital Sirio-Libanes
Ministry of Health, Brazil

Responsible Party: Daniela Franco Bueno, Principal Investigator, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier: NCT03766217     History of Changes
Other Study ID Numbers: CAAE47719215.5.0000.5461
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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