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Completed

NCT Number: NCT06855875

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 .

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Key information

Conditions

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry, Tanta university

Tanta, 31111, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autogenous tooth graft combined with bovine bone

Procedure

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

bovine bone

Procedure

unilateral alveolar cleft which will be repaired using bovine bone .

Primary outcomes

  1. visual analogue scale

    Time frame: 1 month

    0 representing no pain and 10 representing the highest level of pain

  2. inflammation score scale

    Time frame: 1 month

    0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation

Secondary outcomes

  1. bone mineral density

    Time frame: 6 months

    density of bone to measure (D1,D2,D3,D4) from 150 HU to 1250HU

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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