Evaluation of the Efficiency of Bone Born Intra Oral Distractor for Closure of Wide Alveolar Cleft (BBID-WAC)

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

Study Overview

• Status: Completed
• Conditions: Alveolar Cleft; Distraction of Bone
• Intervention / Treatment: Device: Bone-borne Intra oral distractor

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 12345
      • Faculty of oral and dental medicine for Girls AlAzhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Bone-borne Intra oral distractor; Evaluation of the efficiency of the Bone-Borne Intraoral distractors on wide Alveolar cleft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in alveolar cleft defect area measured by cone-beam computed tomography (CBCT) (minimum value: 0 mm²; no predefined maximum value; lower values indicate better outcome)	The alveolar cleft defect area will be quantitatively measured using cone-beam computed tomography (CBCT). Preoperative and postoperative CBCT scans will be superimposed to calculate the change in defect area following distraction osteogenesis.	6 months postoperative follow up
Change in tooth mobility assessed using Miller's Tooth Mobility Index (minimum score: 0; maximum score: 3; higher scores indicate worse mobility)	Tooth mobility will be clinically evaluated using Miller's Tooth Mobility Index to detect and grade the degree of mobility before and after treatment.	6 months postoperative follow up
Vitality of the transported bone segment assessed by clinical vitality indicators after transport distraction osteogenesis (binary outcome: viable / non-viable; viable outcome indicates better result)	Vitality of the transported disk after transport distraction osteogenesis is measured through clinical indicators as No infection, No pain or inflammation, Stable transported segment, Successful consolidation phase.	6 months follow up

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls
• Investigators: Study Chair: Hanaa Elmorsy, Assis.Lec, Assistant lecturer of OMFs department Azhar University; Study Director: Susan H Abdel Hakim, professor, Professor of OMFs department azhar university; Study Director: Wael Shawkat, Consultant, Head of the department at the Health Insurance Hospital; Study Director: Fatema khalifa, Assist.Prof, Assistant Professor of OMFs Azhar university

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Actual): June 29, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Estimated): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Alveolar Cleft; Bone Distraction
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Joint Dislocations; Diastasis, Bone
• Other Study ID Numbers: ORSUR-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Detailed Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No