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

NCT07578207 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2021-12-12
Completion
2022-01-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07578207 on ClinicalTrials.gov