Clinical trial NCT06855875: Evaluation of Autogenous Tooth- Derived Graft With Bovine Bone For Surgical Repair of Unilateral Alveolar Cleft
Official title: Evaluation of Autogenous Tooth- Derived Graft With Bovine Bone For Surgical Repair of Unilateral Alveolar Cleft
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alveolar Cleft
Keywords: teeth derived graft
bovine bone
alveolar cleft grafting
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 16
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: visual analogue scale
timeFrame: 1 month
measure: inflammation score scale
timeFrame: 1 month
Secondary outcomes:
measure: bone mineral density
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: faculty of dentistry, Tanta university
Study officials:
References: