Assessment of effects of elastic upper jaw expander in facial deformity patients using 3D models and xray

Phase 1/2

Recruiting

Conditions: complete unilateral cleft lip and palate patients

Registration Number: CTRI/2018/04/013406

Lead Sponsor: Dr akhil ajay

Brief Summary: Arch expansion is almost a part of the general treatment protocol in the management of unilateral cleft palate. Advantages of arch expansion aims at, space creation for toot alignment in order to achieve favourable arch form, also an additional amount of space is made available in the cleft region for placement of the graft as presurgical orthodontic procedure to aid attempts to enhance esthetics, function, and structural stability in cleft palate patients.

Transverse expansion of the maxillary arch can be achieved with a variety of orthodontic appliances with rapd or slow expansion procedures,using removable or fixed appliance therapy. Correction of posterior crossbites in young patients is often accompanied by a combination of skeletal and dental expansion. The goal of palatal expansion is to maximize skeletal movement and minimize dental movement, while allowing for physiological adjustment of the suture during separation.

Apart from several devices presently available such as RME, quad helix etc., giving both rapid and slow palatal expansion, tandem loop NiTi temperature activated palatal expander developed by Arndt in 1993 and NPE2 by Corbett in 1997 has been made available to produce light continuous pressure on the midpalatal suture.

A correct assessment of the actual effects of all these devices cannot be limited to clinical observations, but requires a quantitative approach. On most occasions, dental and palatal landmarks are digitalised in 3D space and their coordinates are used in mathematical and geometric models.

According to previous studies, high resolution CBCT(also called dental CT) measurement methods have better effects than the model measurement method in the measurement of difference in dental indicators.

Also, finite element method(FEM) termed by Clough in 1960, first introduced to dental arena in 1970s which is an engineering method of calculating stresses and strains in all materials incuding living tissues has made it possible to adequately model the tooth and its supporting structures for scientific checking and validating the clincal assumptions

Thus the aims of this study is to evaluate the effects of NiTi palatal expander on amount of arch expansion and incination of anterior and posterior teeth in complete UCLP using FEM and CBCT.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 20

Inclusion Criteria

unilateral cleft lip and palate patients, age group 7 to 10 years, 2/3rd of the root formation completed of erupting tooth in the area of graft, no associated syndromic conditions, anodontia, atypical or non described cleft diagnosis.

Exclusion Criteria

no associated syndromic conditions, anodontia, atypical or non described cleft diagnosis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transverse expansion in constricted maxillary arch	6 months

Secondary Outcome Measures

Name	Time	Method
nasomaxillary expansion	once in one month

Trial Locations

Locations (1): Institute of Dental Studies and Technologies, Modinagar
🇮🇳
Ghaziabad, UTTAR PRADESH, India
Institute of Dental Studies and Technologies, Modinagar
🇮🇳Ghaziabad, UTTAR PRADESH, India
Dr Akhil Ajay
Principal investigator
7455988036
akhilj2010@gmail.com