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

NCT07578207 | Completed

• 1 other identifier: FDASU-RecM121715
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cleft Lip and/or Palate; Distraction of Bone

Keywords

Alveolar cleft; Interdental distraction osteogenesis (IDO); Tooth-borne distractor; Cone beam computed tomography (CBCT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dental changes with distraction

  2-3 months

• Quality of distracted bone

  3-6 months

• Loss of anchorage with distraction forces

  2-3 months

Study Arms (1)

Tooth borne interdental distraction along arch curvature appliance

EXPERIMENTAL

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

Interventions

Tooth borne Interdental distraction appliance with mini hyrax screw DEVICE

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.

Also known as: Tooth borne alveolar distractor, Buccal mini hyrax distractor

Tooth borne interdental distraction along arch curvature appliance

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Diastasis, Bone

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: January 15, 2018
• Primary Completion: December 12, 2021
• Study Completion: January 1, 2022
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)