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

NCT ID: NCT05422196

Last Updated: 2022-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-06-02

Brief Summary

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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.

Detailed Description

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Conditions

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Alveolar Bone Grafting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

No platelet-rich fibrin was added to the cleft site during grafting.

Group Type NO_INTERVENTION

No interventions assigned to this group

Study group

Platelet-rich fibrin was added to the cleft site during grafting.

Group Type EXPERIMENTAL

Platelet-rich fibrin

Intervention Type PROCEDURE

Addition of platelet-rich fibrin into the cleft site.

Interventions

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Platelet-rich fibrin

Addition of platelet-rich fibrin into the cleft site.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I.
2. Patients seeking treatment and accepting to be enrolled in the study, so as their guardians.
3. Patients who will age 9-14 years old by the surgery day.
4. 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

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

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Dentistry, Mansoura University

Al Mansurah, Addakahlyia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A08080920

Identifier Type: -

Identifier Source: org_study_id

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