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Evaluation Of Comparative efficacy of newly developed Sawangi Flexi Force Expander As Against Conventional Niti Expander in Patients Having Cleft Lip And Palate Deformities A Randomized Control Trial

Evaluation Of Comparative Efficacy Of Newly Developed Indigenous Sawangi Flexi Force Expander As Against Conventional Niti Expander In Patients Having Cleft Lip And Palate Deformities - A Randomized Control Trial - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108381
Enrollment
30
Registered
2026-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: 2- Placement Health Condition 2: 8- Other Procedures

Interventions

Intervention1: SAWANGI FLEXIFORCE EXPANDER: two CBCT scans will be taken for each patient. first just prior to commencement of expansion (T0) and second after six months when expansion is achieved Con

Sponsors

Dr Seema Lahoti
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with cleft lip and palate deformity 2. Age of the patient from 7 years to 14 years 3. Lip and palate repair performed from 3 to 30 months of age 4. Presence of maxillary arch constriction and needs the expansion

Exclusion criteria

Exclusion criteria: 1. Cleft lip and palate patient associated with any other syndrome 2. Multiple carious lesion present 3. Patient with the history of previous orthodontic treatment.

Design outcomes

Primary

MeasureTime frame
we are expecting that sawangi flexi force appliance will give equal or better amount of expansion in comparision with Niti expanderTimepoint: 6 months

Secondary

MeasureTime frame
Expansion amount will be assessed based on transverse and vertical measurements on CBCTTimepoint: 6 months

Countries

India

Contacts

Public ContactSeema Lahoti

sharad pawar dental college

ranjitkamble2506@gmail.com9822231975

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026