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

Phase 3

Completed

• Conditions: Cleft Lip and Palate

• Registration Number: NCT03766217
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-06
• Study Start: 2019-04-05
• Primary Completion: 2019-12-06
• Study Completion: 2019-12-15
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Alveolar bone filling rate	12 months	Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Serious adverse events	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

Name	Time	Method
Non serious adverse events	15 days; 3, 6 and 12 months	Frequency of participants experiencing at least one non serious adverse event
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair	Bone tissue engineering
Alveolar bone filling rate	6 months	Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Patient-reported outcome (PRO, including appearance, fuction and quality of life)	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)
Position of the canine tooth and formation of dental root	12 months	Position of the canine tooth and formation of dental root assessed by CT scan
Serious adverse events	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.

Trial Locations

Locations (1)

Hospital Sírio-Libanes; 🇧🇷 São Paulo, Brazil