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

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

Study Overview

• Status: Completed
• Conditions: Alveolar Cleft
• Intervention / Treatment: Procedure: autogenous tooth graft combined with bovine bone; Procedure: bovine bone

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 .

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31111
    • Faculty of Dentistry, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: autogenous tooth graft combined with bovine bone; This include 8 patients with unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone .	Procedure: autogenous tooth graft combined with bovine bone; unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone .
Experimental: bovine bone; This include 8 patients in whom alveolar cleft will be repaired using bovine bone .	Procedure: bovine bone; unilateral alveolar cleft which will be repaired using bovine bone .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale	0 representing no pain and 10 representing the highest level of pain	1 month
inflammation score scale	0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone mineral density	density of bone to measure (D1,D2,D3,D4) from 150 HU to 1250HU	6 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2024
• Primary Completion (Actual): November 10, 2024
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 29, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: bovine bone; teeth derived graft; alveolar cleft grafting
• Other Study ID Numbers: OS-4-23-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No