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NCT Number: NCT06585566

Alveolar Cleft Reconstruction With Cortical-Shells

The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements.

The study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.

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Key information

Conditions

Alveolar Cleft

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amr Gibaly, Cairo, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft.
  • good oral hygiene and general good health

Exclusion criteria

  • The evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae.
  • Those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing.
  • A history of previous failed alveolar cleft reconstruction.

Treatment and study plan

Cortical-shell graft

Procedure

Retromolar cortical shell graft technique for SABG

Primary outcomes

  1. Horizontal bone width

    Time frame: 6 months consolidation period

    The amplitude of radiographic horizontal bone width change

Secondary outcomes

  1. Vertical bone level

    Time frame: 6 months consolidation period

    The amplitude of radiographic vertical bone change

  2. Bone density

    Time frame: 6 months consolidation period

    The radiographic bone density of the consolidated graft at the site of the reconstructed cleft

Study contacts

Contact information is provided by the study sponsor or research team.

Amr Hanafy Gibaly, PHD

CONTACT

[email protected]

01113336634

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Evaluation of Secondary Alveolar Cleft Reconstruction With Labial and Palatal Retromolar Cortical-Shells (A Case Series Study)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2024
Registry last updated
Jan 22, 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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