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

Not Applicable

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

Registration Number: CTRI/2023/06/053476

Lead Sponsor: Directorate General Armed Forces Medical Services DGAFMS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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.

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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