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

Introduction

Learning to live with a change in the appearance of one’s face due to any injury or disease is a difficult task. It is challenging for children with congenital craniofacial conditions or disease and their parents to adjust. The birth prevalence of non-syndromic cleft lip with or without cleft palate involvement in Indian population of 1.1 billion with birth of 24.5 million per year is between 27,000 to 33,000 cleft per year. Cleft lip and palate is the most common congenital anomaly which has long lasting impacts on the psychological and social life of both the child and the family.

There are different types of cleft lip and palate like incomplete cleft lip, complete cleft lip, bilateral cleft lip and palate, complete cleft palate and complete bilateral cleft palate with cleft alveolus. The most commonly impacted growth is of the maxillary bone which is almost around 75% and that directly affects the alveolar bone which results in the collapse of alveolar segments and affects tooth development and eruption.

Complete rehabilitation of cleft lip and palate requires an interdisciplinary approach. Orthodontic problem of patient with cleft palate is not only due to the cleft but also due to the surgical intervention which causes the maxillary constriction. Expansion of maxilla is the procedure to correct relative and absolute maxillomandibular buccolingual discrepancies. Expansion of narrow or collapsed maxillary arches can be achieved through orthodontic and orthopedic forces often differ in term of objectives, application, intensity, time, timing and type of force.

Maxillary arch expansion is the best method to treat the transverse deformities either skeletal or dentoalveolar and to reduce the crowding too. Expansion of the maxilla can help in the transverse opening of maxilla, correction of crossbite and increase in the arch length. Rationale of expansion is “the opening of expansion screw will open the midpalatal suture in growing children. Various type of expansion appliances is available in the market and used in orthodontics today.

Expansion across the mid-palatine suture can be done in two ways depending upon the speed at which it is carried out that is slow and rapid. Rapid expansion exerts forces ranging from 3-20 pounds giving around 1mm of expansion every day but known to cause discomfort and pain with high rates of relapse while slow expansion exerts 2 pounds of force and gives around 1mm of expansion every week and provides almost similar amount of skeletal and dental expansion over 10-12week period as rapid expansion. Systematic review had found no robust evidence of differences between slow maxillary expansion and the rapid maxillary expansion for the correction of maxillary dental arch constriction and crossbite.

As we all know that the complete management of cleft patient requires a team of multiple people including caretakers, anganwadi workers, plastic surgeons, oral surgeons, dentist, orthodontist and speech therapist along with the main connecting link of parents who are the constant support to the child. Existing multi-speciality care is primarily aimed at physical rehabilitation with the psychological issues of care often being neglected. The parents and the patients perceptions and needs area critical component of eventual outcome, yet they are frequently overlooked. Hence the psychological impact on parents will have a direct effect on the child which also needs the utmost care and attention.

The maximum cleft lip and palate patient in India belongs to the poor socio-economic status and cannot afford the treatment. The treatment with Rapid palatal expander becomes expensive which cannot be affordable by the patients. Without going for expansion in maximum cleft patients the proper orthodontic treatment can never be achieved. The Sawangi Flexi Force appliance which is made up of 21gauge stainless steel wire soldered on to the customized bands prepared on the first permanent molar. This is definitely cost effective but the effect of it on achieving the proper expansion in comparison to the NiTi palatal expander is needed to be evaluated. Thus the aim of this study will be to compare the dentoalveolar effects of Sawangi Flexi Force appliance verses the NiTi palatal expanders in patients with cleft deformities and to see the psychological and dental aesthetic impact before and after the expansion.

Methodology

1.The study will be conducted in the department of orthodontics and dentofacial orthopaedics, SPDC Sawangi after obtaining prior sanction from the scientific and ethical committee of the institution.

2.Consecutive patients of cleft lip and palate will be recruited at the institution during the study period. Consent will be obtained from the participant’s legal guardian before their recruitment. The questionnaire will be filled by the parent and the participant for the psychological impact after randomization of the sample into 2 groups.

3.Group I will be the patient on which the expansion will be achieved with Sawangi flexi Force appliance and Group II in which the expansion will be achieved with the NiTi Expanders.

4.Pretreatment and posttreatment models, PA view Skull and CBCT will be taken for the patients of both the groups to see the archwidth changes in canine, premolar and molar region. Bizygomatic changes via PA view and transverse expansion with help of CBCT. The morphometric analysis will be done by evaluating all this factors before and after the treatment.

EXPECTED RESULT We are expecting that Sawangi Flexi Force Expander will give equal results in comparision with Niti expanders

CONCLUSION

If Sawangi Flexi Force Expander shows equal or better results in comparision with Niti expanders in cleft deformities, it would be advantageous to use the cost effective and less chair side time required to deliver the appliance

KEY WORDS

Cleft patient, expansion, finite element method, NiTi palatal expander, Sawangi Flexi Force Expander