Tooth-borne Interdental Distraction Osteogenesis Along Arch Curvature for Wide Alveolar Clefts Reduction (IDO)

A New Device for Interdental Distraction Osteogenesis for Management of Wide Alveolar Clefts

This clinical study provided a modified simple and small appliance for reduction of wide alveolar clefts in cleft lip and palate patients, making the grafting procedure of better prognosis and increase its success rate.

Study Overview

• Status: Completed
• Conditions: Distraction of Bone; Cleft Lip and/or Palate
• Intervention / Treatment: Device: Tooth borne Interdental distraction appliance with mini hyrax screw

Detailed Description

Along the journey of treatment of cleft patients, secondary autogenous alveolar bone grafting is the technique basically used for cleft alveolus and palate repair during mixed dentition stage, in order to create bone support for teeth adjacent to the cleft, making a bone matrix through which teeth in the line of the cleft can erupt, re-stabilize alveolar process contour and maxillary segments. In cases with wide alveolar clefts, more than the width of a maxillary canine, failure of this procedure is usually encountered. So, a further step prior to grafting procedure can be done in an attempt to reduce cleft width to enhance success of future grafting.

Distraction osteogenesis (DO) which is a procedure of growing new bone by mechanical stretching of the ordinary pre-existing vascularized bone tissue by a distraction device, where both segments of new alveolar bone as well as attached gingiva are formed can be used here to aid in minimizing cleft width.

The aim of this study was to introduce a new custom-made tooth-borne distractor that could provide 3D control upon using interdental distraction osteogenesis (IDO) with a posterior segment transport anteriorly along curvature of the arch through creating a controlled fracture, then applying this distractor device carrying a bone transport segment forward, decreasing the cleft width anteriorly with another benefit of leaving behind regenerated bone and attached gingiva posteriorly.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Department of Orthodontics, Faculty of Dentistry, Ain Shams University Cairo, Abbaseya, Egypt

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with ages ranging from 12 to 25 years old
• Patients with repaired cleft lip and / or palate.
• Patients with wide alveolar clefts more than 6 mm.
• Patients with median facial clefts, absent premaxilla.
• Patients who had previous failed grafting.

Exclusion Criteria:

• Patients with contraindications to general anaesthesia and surgery.
• Patients with syndromic cleft lip and palate.
• Patients with very bad oral hygiene.
• Vulnerable groups.

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: Tooth borne interdental distraction along arch curvature appliance; Patients eligible to the study were prepared to receive interdental distraction osteogenesis. The appliance was custom made for each patient. It is made up of orthodontic bands, labial, palatal stainless steel 0.9mm arches and micro expander screw soldered to the first permanent molar and to the first premolar in the transport segment .

Device: Tooth borne Interdental distraction appliance with mini hyrax screw; This study aimed to provide a new design of a tooth-borne, custom-made distractor that could be easily constructed and rigid enough for controlled segment transport. After cases' selection, arch expansion was done first. Following expansion, preparation of the osteotomy site was done, through inducing root divergence at site of interdental osteotomy. Osteotomies were performed under general anesthesia using piezo-surgery, there were 2 osteotomies in a L-shape; interdental vertical osteotomy mesial to 1st molar and a horizontal one above apices of teeth in the transport segment. The distraction protocol was a latency period of 7 days, after which appliance activation started with a distraction rate of 0.4 mm/day with a rhythm of twice daily. Activation proceeded till teeth at the edge of the cleft came into contact. Then the appliance was fixed in place for a 3 months consolidation period.; Other Names: Tooth borne alveolar distractor; Buccal mini hyrax distractor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of width of alveolar cleft and oronasal fistula	Reduction or even closure of the wide interdental alveolar defect and the oronasal fistula measured on CBCT radiograph	2-3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental changes with distraction	Amount of dental tipping that occurred with distraction forces measured on CBCT radiograph	2-3 months
Quality of distracted bone	Measurement of bone radio density in Hounsfield Unit from CBCT	3-6 months
Loss of anchorage with distraction forces	Amount of distal movement of anchor molar of the assembly as a side effect of the mesial distraction forces measured on CBCT radiograph	2-3 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): December 12, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cone beam computed tomography (CBCT); Alveolar cleft; Interdental distraction osteogenesis (IDO); Tooth-borne distractor
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Joint Dislocations; Diastasis, Bone
• Other Study ID Numbers: FDASU-RecM121715

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No