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COMPLETED
NCT07578207
NA

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2018-01-15

Completion Date

2022-01-01

Last Updated

2026-05-11

Healthy Volunteers

No

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.

Locations (1)

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

Cairo, Egypt