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

NCT07306429 | Completed

• 1 other identifier: ORSUR-10
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alveolar Cleft; Distraction of Bone

Keywords

Alveolar Cleft; Bone Distraction

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Bone-Borne Intra-oral distractor

EXPERIMENTAL

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

Interventions

Bone-borne Intra oral distractor DEVICE

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

Bone-Borne Intra-oral distractor

Eligibility Criteria

• Age: 7 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Faculty of oral and dental medicine for Girls AlAzhar University

Cairo, Cairo Governorate, 12345, Egypt

Location

MeSH Terms

Conditions

Diastasis, Bone

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Hanaa Elmorsy, Assis.Lec

  Assistant lecturer of OMFs department Azhar University

  STUDY CHAIR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This wasn't applicable during surgery and follow-up
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at Oral and Maxillofacial Surgery department at AlAzhar University

Model Details: stereographic models were used for construction of bone-borne custom-made intraoral distractor

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 29, 2025
• Study Start: March 14, 2023
• Primary Completion: June 29, 2025
• Study Completion: December 1, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)