Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

Evaluation of Esthetic Satisfaction and Bone Augmentation Quality Using Purabone Added to β-tricalcium Phosphate Versus β-tricalcium Phosphate Alone in Secondry Alveolar Cleft Grafting . Randomized Controlled Clinical Trial

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03016793

Enrollment

Registered

2017-01-11

Start date

2017-01-31

Completion date

2017-12-31

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Cleft Grafting

Brief summary

P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number 0-10 Radiographic outcome: Outcome name Measurment Device Measurment unite Bone volume (Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density (Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying than tricalcium phosphate alone in alveolar cleft grafting?

Interventions

DRUGPuerarin

purabone (puerarin) is a bone graft used for surgical repair of bony defects.

DRUGβ- tricalcium phosphate

β- tricalcium phosphate is a bone graft used for surgical repair of bony defects

DRUGβ- tricalcium phosphate alone

β- tricalcium phosphate is a bone graft used for surgical repair of bony defects

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

8 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

1. Patients with unilateral alveolar cleft indicated for bone grafting. 2. Patients age range between 8-12years.

Exclusion criteria

1. Patients with any systemic diseases that can affect normal bone and/or wound healing. 2. Patients with bilateral alveolar clefts.

Design outcomes

Primary

Measure	Time frame	Description
Esthetic satisfaction	6 months	outcome measured by numerical scale from 1-10

Secondary

Measure	Time frame	Description
bone volume	6 months	outcome measured by cone beam computed tomography ( CBCT)
bone density	6 months	Outcome measured by cone beam computed tomography (CBCT)

Countries

Egypt

Contacts

Primary ContactMohamed H Maklad, BSC

dentomaklad@yahoo.com+201002648553

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026