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Comparison of the pain perception and transverse changes following expansion with quad helix appliance fabricated from stainless steel (SS) and titanium molybdenum alloy (TMA) among patients with unilateral cleft lip and palate: a randomized clinical trial

Comparison of the pain perception and transverse changes following expansion with quad helix appliance fabricated from stainless steel and titanium molybdenum alloy among patients with unilateral cleft lip and palate: a randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097542
Enrollment
28
Registered
2025-11-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: Q375- Cleft hard and soft palate with unilateral cleft lip

Interventions

Intervention1: Quadhelix appliance made up of Titanium molybdenum alloy: appliance fabricated with Titanium molybdenum alloy for 3 months of duration Control Intervention1: Quadhelix appliance made of

Sponsors

Dr Ashwin T
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with unilateral cleft lip and palate (Group 3) with unilateral or bilateral crossbite in need of bilateral expansion for crossbite correction Age group: 8-13 years Mixed dentition and permanent dentition period Patients who consent to participate in the study

Exclusion criteria

Exclusion criteria: Patients who had undergone previous orthodontic treatment for expansion Craniofacial anomalies Absence of maxillary permanent first molars

Design outcomes

Primary

MeasureTime frame
To assess and compare pain and discomfort of following expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate using Visual Analogue Scale (VAS) and Modified McGill Pain Questionnaires.Timepoint: At 4 hours, at 6 hours, at 24 hours, at 2 days and at 7 days

Secondary

MeasureTime frame
To assess and compare the transverse skeletal changes in the maxilla after 3 months of expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate on CBCT.Timepoint: pre treatment and at 3 months;To assess and compare the change in intercanine and intermolar width in the maxilla after 3 months of expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate on plaster study modelsTimepoint: at pretreatment and at 3 months

Countries

India

Contacts

Public ContactAshwin

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH

aswin5550@gmail.com6369159263

Outcome results

None listed

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