Trial Outcomes & Findings for Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients (NCT NCT01932164)
NCT ID: NCT01932164
Last Updated: 2020-05-28
Results Overview
The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.
COMPLETED
NA
5 participants
6 months from surgical procedure for alveolar grafting;
2020-05-28
Participant Flow
the recruitment of 5 patients was performed at dentistry department of Hospital Menino Jesus between june and august 2013.
Participant milestones
| Measure |
Cleft Lip and Palate
Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment
maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
Cleft Lip and Palate
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
Baseline characteristics by cohort
| Measure |
Cleft Lip and Palate
n=5 Participants
5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery
maxillary alveolar graft by tissue engineering: Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;
Bone tissue engineering using mesenchymal stem cells: Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.
|
|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months from surgical procedure for alveolar grafting;Population: 3 females and 2 males with cleft lip and palate
The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.
Outcome measures
| Measure |
Cleft Lip and Palate
n=5 Participants
Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment
maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.
|
|---|---|
|
Amount of New Bone Mass Formed
|
89 percentage of bone formation
Interval 89.0 to 100.0
|
PRIMARY outcome
Timeframe: Three months after the graftThe quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques. We are waiting the canine eruption at the mouth.
Outcome measures
| Measure |
Cleft Lip and Palate
n=5 Participants
Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment
maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.
|
|---|---|
|
Quality of Bone Regeneration
|
90 percentage of bone filling
Interval 80.0 to 100.0
|
Adverse Events
Cleft Lip and Palate
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place