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

NCT03766217 | Completed Phase 3

• 1 other identifier: CAAE47719215.5.0000.5461
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip and Palate

Outcome Measures

Primary Outcomes (2)

• Alveolar bone filling rate

  Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.

  12 months

• 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 Outcomes (6)

• Non serious adverse events

  15 days; 3, 6 and 12 months

• Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair

  Bone tissue engineering

• Position of the canine tooth and formation of dental root

  12 months

• Alveolar bone filling rate

  6 months

• Serious adverse events

  15 days; 3 and 6 months

Study Arms (2)

Mesenchymal stem cells associated with biomaterials

EXPERIMENTAL

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

Iliac crest autogenous bone graft

ACTIVE COMPARATOR

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

Interventions

Mesenchymal stem cells associated with biomaterials COMBINATION_PRODUCT

Deciduous dental pulp mesenchymal stem cells associated with hydroxyapatita/collagen.

Mesenchymal stem cells associated with biomaterials

Iliac crest autogenous bone graft COMBINATION_PRODUCT

Autogenous bone will be obtained from iliac crest.

Iliac crest autogenous bone graft

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• non syndromic unilateral cleft lip and palate;
• age between 7 and 12 years;
• to have the jaw aligned and ready to receive the graft.

You may not qualify if:

• previous surgery to correct the alveolar cleft;
• have the canine erupted before grafting;
• incomplete orthodontic treatment;
• incomplete CT scan documentation.

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Hospital Sírio-Libanes

São Paulo, 01308-050, Brazil

Location

Related Publications (2)

• 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.

  PMID: 32256610 BACKGROUND

• 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.

  PMID: 31781247 BACKGROUND

MeSH Terms

Conditions

Cleft Lip

Interventions

Biocompatible Materials

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 6, 2018
• Study Start: April 5, 2019
• Primary Completion: December 6, 2019
• Study Completion: December 15, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

BR (1)