Skip to main content
OpenTrials
Completed

NCT Number: NCT07306429

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alveolar Cleft Diastasis, Bone Distraction of Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Age range

7 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of oral and dental medicine for Girls AlAzhar University

Cairo, Cairo Governorate, 12345, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Bone-borne Intra oral distractor

Device

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

Primary outcomes

  1. 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)

    Time frame: 6 months postoperative follow up

    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.

  2. Change in tooth mobility assessed using Miller's Tooth Mobility Index (minimum score: 0; maximum score: 3; higher scores indicate worse mobility)

    Time frame: 6 months postoperative follow up

    Tooth mobility will be clinically evaluated using Miller's Tooth Mobility Index to detect and grade the degree of mobility before and after treatment.

  3. 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)

    Time frame: 6 months follow up

    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.

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Registry information

Acronym: BBID-WAC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2025
Registry last updated
Jan 7, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.