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Evaluation of Autogenous Tooth- Derived Graft With Bovine Bone For Surgical Repair of Unilateral Alveolar Cleft

Evaluation of Autogenous Tooth- Derived Graft With Bovine Bone For Surgical Repair of Unilateral Alveolar Cleft

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06855875
Enrollment
16
Registered
2025-03-04
Start date
2024-08-10
Completion date
2025-05-28
Last updated
2025-07-01

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

Conditions

Alveolar Cleft

Keywords

teeth derived graft, bovine bone, alveolar cleft grafting

Brief summary

The aim of this study is evaluation of autogenous tooth-derived graft combined with bovine bone for surgical repair of unilateral alveolar cleft .

Detailed description

Decalcified dentin graft is thought to be a good graft material that can substitute existing autogenous bone graft materials. It can be easily and readily available, with minimal risk of infection, minimal donor site morbidity as no vital bone is sacrificed, it can be easily shaped to fit into the bony defect and it can be used as block or in powder forms, the hypothesis is to evaluate the biological and the physical properties of both and autogenous tooth derived graft and bovine bone to increase the quality and density of newly formed bone in alveolar cleft grafting Criteria of patient selection: Inclusion Criteria: Patients with unilateral alveolar clefts requiring repair. patients free from any systemic disease that may affect normal healing of bone. patients in an age 7y up to 14 y. patients have teeth to be sacrificed, as primary teeth, carious teeth, malposed teeth, supernumerary tooth& non functional tooth in the study group. Exclusion criteria: Bilateral alveolar clefts. Immunocompromized patients. Syndromic patients. Patients have good full set of teeth, cannot be sacrified in study group The patients grouping with unilateral alveolar cleft will be classified into two equal groups according to the grafting material used for alveolar cleft repair. Study Group: This will include 8 patients with unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone . Control Group: This will include 8 patients in whom alveolar cleft will be repaired using bovine bone .

Interventions

PROCEDUREautogenous tooth graft combined with bovine bone

unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone .

PROCEDUREbovine bone

unilateral alveolar cleft which will be repaired using bovine bone .

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with unilateral alveolar clefts requiring repair. * patients free from any systemic disease that may affect normal healing of bone. * patients in an age 7y up to 14 y. * patients have teeth to be sacrificed, as primary teeth, carious teeth, malposed teeth, supernumerary tooth& non functional tooth in the study group.

Exclusion criteria

* Bilateral alveolar clefts. * Immunocompromized patients. * Syndromic patients. * Patients have good full set of teeth, cannot be sacrified in study group

Design outcomes

Primary

MeasureTime frameDescription
visual analogue scale1 month0 representing no pain and 10 representing the highest level of pain
inflammation score scale1 month0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation

Secondary

MeasureTime frameDescription
bone mineral density6 monthsdensity of bone to measure (D1,D2,D3,D4) from 150 HU to 1250HU

Countries

Egypt

Outcome results

None listed

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