Skip to content

A clinical study to evaluate expansion of maxilla with devices using implants over conventional expansion methods in patients with transverse deficiency of maxilla

Randomised Controlled Trial to evaluate maxillary expansion with palatal mini-implants over conventional expansion protocols in patients with transverse maxillary deficiency- A three-dimensional Cone Beam Computed Tomography (CBCT)study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053476
Enrollment
45
Registered
2023-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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: Implant supported expansion appliance: Palatal mini-implant-supported maxillary expansion appliance for 6 months followed by fixed orthodontic mechanotherapy Control Intervention1: Conv
total duration upto 2 years

Sponsors

Directorate General Armed Forces Medical Services DGAFMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (a) Growing patients with transverse maxillary deficiency between 4mm-10mm with either unilateral or bilateral posterior crossbites involving several teeth. (b) A treatment plan indicating the use of rapid maxillary expansion to correct a transverse maxillary deficiency or a tooth-arch length discrepancy. (c) The presence of at least ten teeth in each arch

Exclusion criteria

Exclusion criteria: (a) Subjects with less than ten teeth in each arch (b) Subjects with poor co-operation (c) Subjects who have skeletal asymmetry of the maxilla or mandible and those with severe anteroposterior and vertical skeletal discrepancy (d) Subjects exhibiting anterior open bite, steep mandibular plane and convex profile (e) Adult subjects with fusion completed in the palatine bone and with no evidence of a suture (f) Subjects with history of previous orthodontic treatment (g) Subjects with history of reconstructive surgery (h) Subjects with craniofacial deformity, such as cleft lip and ? or palate (i) Subjects with history of pharyngeal surgery (j) Subjects with metabolic disorders which are associated with suture synotoses (k) Subjects with patient-specific disorders (such as neuromuscular disorders)

Design outcomes

Primary

MeasureTime frame
To evaluate the immediate and long-term effects of rapid maxillary expansion (RME) with palatal mini-implant supported expanders and tooth-borne expanders on the transverse, vertical and antero-posterior skeletal, dentoalveolar and airway parameters, using CBCT.Timepoint: 4 intervals; Baseline (T0), immediately after expansion(T1) at around 6 weeks, after removal of the appliance (T2)at around 6 months, on completion of fixed orthodontic mechanotherapy(T3) at around 20-24 months

Secondary

MeasureTime frame
To determine whether there are any significant differences in orthodontic tooth movement, when palatal mini-implant supported maxillary expanders are used over conventional methodsTimepoint: 4 intervals; Baseline (T0), immediately after expansion(T1) at around 6 weeks, after removal of the appliance (T2) at around 6 months, on completion of fixed orthodontic mechanotherapy(T3) at around 20-24 months

Countries

India

Contacts

Public ContactOOMMEN NAINAN

INHS Kalyani

droommennainan@yahoo.in9869860710

Outcome results

None listed

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