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Comparing two methods of upper arch widening for secondary bone placement in children with single lip and upper arch split using clear aligner and fixed expander.

A COMPARATIVE EVALUATION OF ARCH PREPARATION FOR SECONDARY ALVEOLAR BONE GRAFTING IN UNILATERAL CLEFT LIP AND PALATE PATIENTS USING KIYOCLEAR ALIGNERS AND TRADITIONAL SLOW EXPANDERS :A RANDOMISED CONTROLLED TRIAL - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/064988
Enrollment
58
Registered
2024-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: M262- Anomalies of dental arch relationship Health Condition 2: Q371- Cleft hard palate with unilateralcleft lip Health Condition 3: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: KIYOCLEAR ALIGNER: Transverse maxillary expansion done in unilateral cleft lip and palate using KiyoClear Aligner , Duration:8 months Control Intervention1: QUAD HELIX: Transverse maxil

Sponsors

SHEEPMEDICAL INDIA PRIVATE LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. Patients with unilateral cleft lip and palate ii. Non syndromic iii. No congenital abnormalities iv. No history of previous orthodontic treatment

Exclusion criteria

Exclusion criteria: i. Individuals having cleft lip and palate with any syndromes, congenital disorders ii. Individuals with systemic diseases affecting bone density iii. Previous orthodontic intervention iv. Erupted permanent canine v. Bilateral CLCP patients

Design outcomes

Primary

MeasureTime frame
Clinically there is a significant difference in arch expansion(parameters - arch length, inter-canine distance, inter-molar distance, palatal volume, tooth long axis,arch perimeter, palatal depth) using a KiyoClear aligner & quad helix.Timepoint: 2 Years—

Secondary

MeasureTime frame
More patient cooperation & comfort & cost benefit ratio with KiyoClear aligner than with QuadHelixTimepoint: 2 Years—

Countries

India

Contacts

Public ContactDR.CHRISTEENA JOSEPH

MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES FARIDABAD

drpuneetbatra@gmail.com09380886510

Outcome results

None listed

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