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Using a Custom Tooth-Supported Expansion Device (HYRAX Screw) Inside the Mouth to Close Wide Unilateral Alveolar Clefts A Clinical Study.

Effectiveness of Intraoral Tooth-Borne Custom-Made Distractor using HYRAX Screw in the Closure of Unilateral Wider Alveolar Clefts A Single Arm Clinical Trial. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106888
Enrollment
13
Registered
2026-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified

Interventions

Intervention1: Intraoral Tooth-Borne, Custom-Made Distractor using HYRAX Screw.: Intraoral Tooth-Borne, Custom-Made Distractor using HYRAX Screw placed at the osteotomy site. Then the hyrax screw will

Sponsors

Preksha Shetty
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the patients reporting to department with unilateral wider alveolar cleft defect, width of 8-12mm Patients fit to undergo the surgical procedure under general anaesthesia. Patients of age 9-16 years. Periodontally sound teeth with adequate bone support. Patients who have given Informed consent.

Exclusion criteria

Exclusion criteria: Syndromic patients Patients with habit of smoking, kharra chewing, tobacco chewing. Patients not willing to participate in the study.

Design outcomes

Primary

MeasureTime frame
1.To evaluate the size of alveolar cleft. Timepoint: 1.To evaluate the size of alveolar cleft after completion of the consolidation of 3 months i.e. post surgery 4 months.

Secondary

MeasureTime frame
1. To evaluate the position, vitality & mobility of teeth in the distraction segment. 3. To evaluate the quality of the newly regenerated bone at the distraction site. 4. To evaluate the need for post-distraction alveolar bone grafting. Timepoint: 4 months post the osteotomy & Hyrax placement surgery

Countries

India

Contacts

Public ContactPreksha Shetty

Government Dental College and Hospital Nagpur

shwetasonwane.2024@rediffmail.com09664999264

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026