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Completed

NCT Number: NCT03766217

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

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.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Sírio-Libanes

São Paulo, 01308-050, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mesenchymal stem cells associated with biomaterials

Combination Product

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

Iliac crest autogenous bone graft

Combination Product

Autogenous bone will be obtained from iliac crest.

Primary outcomes

  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 outcomes

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

    Time frame: Bone tissue engineering

  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: pre surgery and 12 months

    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)

Sponsors and collaborators

Lead sponsor

Hospital Sirio-Libanes

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Acronym: CLOSE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2018
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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