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Evaluation of the Efficiency of Bone Born Intra Oral Distractor for Closure of Wide Alveolar Cleft

NCT ID: NCT07306429

Last Updated: 2025-12-29

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2025-12-01

Brief Summary

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The study aimed to determine efficiency of Bone-Born Intraoral Distractor on wide Alveolar cleft patients

Detailed Description

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Stereographic models were used for construction of bone-born custom-made intraoral distractor according to the inclusion and exclusion criteria, followed up to measure and determine the efficiency of the distractor

Conditions

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Alveolar Cleft Distraction of Bone

Keywords

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Alveolar Cleft Bone Distraction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

stereographic models were used for construction of bone-borne custom-made intraoral distractor
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This wasn't applicable during surgery and follow-up

Study Groups

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Bone-Borne Intra-oral distractor

Surgeries to fix the device were conducted under GA. Then latency period of seven days was applied. Activation was 0.5 mm twice a day. The transport segment touched the docking site then the Consolidation period is achieved. Follow up for 6 months.

Group Type EXPERIMENTAL

Bone-borne Intra oral distractor

Intervention Type DEVICE

Evaluation of the efficiency of the Bone-Borne Intraoral distractors on wide Alveolar cleft

Interventions

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Bone-borne Intra oral distractor

Evaluation of the efficiency of the Bone-Borne Intraoral distractors on wide Alveolar cleft

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with wide alveolar clefts more than 8ml either unilateral or bilateral or median facial cleft.
* Patients who had previous failed grafting also may be included.
* Age range of patients 7-20 years old, with no gender prediction, able to read and sign the informed consent (parents)
* Patients with median facial clefts.

Exclusion Criteria

* Narrow alveolar cleft
* Syndromic patients.
* Oral soft tissues defects, inflammation, infections and bone metabolism disturbance.
* Allergy to titanium implant.
* Patient with systemic disease and immunocompromised patient.
Minimum Eligible Age

7 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculty of Dental Medicine for Girls

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hanaa Elmorsy

Assistant Lecturer at Oral and Maxillofacial Surgery department at AlAzhar University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanaa Elmorsy, Assis.Lec

Role: STUDY_CHAIR

Assistant lecturer of OMFs department Azhar University

Susan H Abdel Hakim, professor

Role: STUDY_DIRECTOR

Professor of OMFs department azhar university

Wael Shawkat, Consultant

Role: STUDY_DIRECTOR

Head of the department at the Health Insurance Hospital

Fatema khalifa, Assist.Prof

Role: STUDY_DIRECTOR

Assistant Professor of OMFs Azhar university

Locations

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Faculty of oral and dental medicine for Girls AlAzhar University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ORSUR-10

Identifier Type: -

Identifier Source: org_study_id