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Completed

NCT Number: NCT05422196

Evaluation of Computer-Guided Secondary Alveolar Cleft Bone Grafting With and Without Platelet-Rich Fibrin

This study aims at investigating the role of platelet-rich fibrin in alveolar cleft secondary grafting. This grafting is done from the patient's chin using a computer-guided stent that is customized for each patient, and the cleft volume is analysed at first to estimate the needed amount of bone to be harvested.

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Key information

Conditions

Alveolar Bone Grafting

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Addakahlyia, 35516, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I.
  • Patients seeking treatment and accepting to be enrolled in the study, so as their guardians.
  • Patients who will age 9-14 years old by the surgery day.
  • Patients with adequate chin bone volume that could be harvested without marked donor site morbidity, as pre-determined by cone beam computed tomography.

Exclusion criteria

  • Patients with systemic illness, i.e. ASA(22) classes II, III, IV, and V.
  • Patients with previously operated alveolar clefts and seeking revision for the same cleft.
  • Patients that wouldn't be able to attend the recalls.
  • Patients with other craniofacial anomalies and associated syndrome conditions.
  • Edentulous maxilla, atypical or non-described cleft diagnosis.
  • Patients with history of chemotherapy or radiotherapy.

Treatment and study plan

Platelet-rich fibrin

Procedure

Addition of platelet-rich fibrin into the cleft site.

Primary outcomes

  1. Closure of oronasal fistula

    Time frame: Ten days postoperatively

    • By questioning the patient if there's a nasal regurgitation or not.
    • Qualitative outcome (positive or negative).

  2. Closure of oronasal fistula

    Time frame: Six months postoperatively

    • By questioning the patient if there's a nasal regurgitation or not.
    • Qualitative outcome (positive or negative).

  3. Volume of newly formed bone

    Time frame: Six months postoperatively

    • By computerized measurement on the Cone-Beam Computed Tomography software. (Volume tool in Invesalius ® software (Invesalius, CTI, Brazil)).
    • Quantitative outcome (in cubic millimetres (mm3)).

  4. Average density of newly formed bone

    Time frame: Six months postoperatively

    • By computerized measurement on the Cone-Beam Computed Tomography software. (Average density tool in Invesalius ® software (Invesalius, CTI, Brazil)).
    • Quantitative outcome (in Hounsfield Units (HU)).

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 16, 2022
Registry last updated
Jun 16, 2022

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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