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Completed

NCT Number: NCT07578207

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

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.

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Key information

Conditions

Cleft Lip and/or Palate Diastasis, Bone Distraction of Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Other names: Tooth borne alveolar distractor, Buccal mini hyrax distractor

Primary outcomes

  1. Reduction of width of alveolar cleft and oronasal fistula

    Time frame: 2-3 months

    Reduction or even closure of the wide interdental alveolar defect and the oronasal fistula measured on CBCT radiograph

Secondary outcomes

  1. Dental changes with distraction

    Time frame: 2-3 months

    Amount of dental tipping that occurred with distraction forces measured on CBCT radiograph

  2. Quality of distracted bone

    Time frame: 3-6 months

    Measurement of bone radio density in Hounsfield Unit from CBCT

  3. Loss of anchorage with distraction forces

    Time frame: 2-3 months

    Amount of distal movement of anchor molar of the assembly as a side effect of the mesial distraction forces measured on CBCT radiograph

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: IDO

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 11, 2026
Registry last updated
May 11, 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.

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