Skip to content

Examining pain experience and other dental and skeletal changes in patients affected with cleft disorder due to upper jaw expansion: A comparison Of two expansion devices

Comparison and assessment of pain and dentoskeletal changes in cleft patients during rapid maxillary expansion - a randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068906
Enrollment
16
Registered
2024-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: - Health Condition 2: K089- Disorder of teeth and supporting structures, unspecified

Interventions

Intervention1: hyrax maxillary expansion device: Patients with unilateral cleft who will undergo maxillary expansion with hyrax expander will be involved in this group pre-expansion and post-expansion

Sponsors

Post Graduate Resident Stipend
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient with non-syndromic cleft lip and palate 2.Patients with unilateral cleft. 3.Patients undergoing orthodontic treatment with rapid maxillary expansion. 4.Patient of both genders within the age group of 10 yrs - 15 yrs. • No history of previous orthodontic treatment

Exclusion criteria

Exclusion criteria: 1.Smokers/ Individual with pan chewing habit 2.Patients with any systematic conditions 3.History of antibiotic or anti-inflammatory drug therapy in the past 7 days

Design outcomes

Primary

MeasureTime frame
To measure the Predesignating (PGE2) expression and VAS score Timepoint: 1 hour before insertion of expander: baseline (T0); day 1 - 15minutes after activation of expander (T1); day 4 - 15minutes after activation of expander (T2); day 7 - 15minutes after activation of expander (T3).

Secondary

MeasureTime frame
4. To measure the dentoskeletal effects in hyrax expander group & fan-type expander groupTimepoint: pre-expansion radiographs (baseline) post-expansion radiographs (2 weeks)

Countries

India

Contacts

Public ContactDr C Siva Subramanian

Sri Ramachandra Institute of Higher Education and Research

sivasubramanian.c@sriramachandra.edu.in9840025621

Outcome results

None listed

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