Influence of orthopedic therapy in cleft lip palate patient

Completed

Conditions: Cleft patients undergoing skeletal correction

Registration Number: CTRI/2017/02/007964

Lead Sponsor: Yenepoya University

Brief Summary: Cleft lip and palate is one of the commonest craniofacial disorders with incidence ranging from 1 in 300 to 1 in 2,500 live births. In India, 78 cleft infants are born every day, or 3 infants with clefts born every hour. Cleft lip and palate patients need extensive treatment from early age until adulthood. Primary surgeries have an effect on growth of the maxillofacial complex.

Deficient maxilla (both in transverse and sagittal dimension) is one of the most common features of surgically corrected cleft lip and palate which is thought to be due to the presence of the scar tissue.

To correct the transverse discrepancies, orthodontists often use orthopedic appliances such as expansion appliances and to correct the sagittal discrepancies, face mask is used. The combined use of expansion appliance and a facemask is a contemporary technique for maxillary protraction during growth in cleft patients. However, the use of facemask has few shortcomings such as long duration of wear and the efficacy of appliance is highly dependent on patient compliance. Max gym is a dentofacial orthopaedic apparatus, proposed to protract the maxilla using variable weights stacked upon a pulley mechanism via a maxillary splint with incorporated expansion appliances. The patient is trained to pull away from this appliance which will help in correcting maxillary deficiency in sagittal and transverse dimension. The difference between face mask and the max gym is that, the anchorage taken by the appliance is from the wall as opposed to the patientâ€™s chin and forehead as in face mask therapy. The forces used to bring about skeletal changes in max gym are heavier and the duration of use is much lesser unlike the face mask which has lighter and continuous forces. Patientâ€™s compliance is better as it eliminates wearing of extra oral appliance for longer duration**.** There is general agreement that orthopedic forces applied to the maxillary complex are more effective in growth modulation and invasive surgical procedure can be minimized/avoided at a later date.

This study will assess and compare the changes in craniofacial structures by two different protraction appliances using Cone Beam Computed Tomography (CBCT).

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients with NSUCLP between the age of 9-16 years.
Cleft patients in mixed/ permanent dentition.
Cleft patients with a history of primary surgery for repair of cleft lip and palate need to address sagittal discrepancy.
Cleft patients with constricted arch need to undergo expansion.
No gross facial symmetry determined clinically.

Exclusion Criteria

Syndromic cleft lip and palate patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To check whether intervention appliance can be used as substitute for orthopedic correction	12months after the appliance intervention

Secondary Outcome Measures

Name	Time	Method
Newly introduced appliance can	generalized in all population with deficient maxilla

Trial Locations

Locations (2): GSR Institute of Craniofacial Surgery
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Yenepoya University
🇮🇳
Kannada, KARNATAKA, India
GSR Institute of Craniofacial Surgery
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dr Srinivas Gosla Reddy
Principal investigator
9849016969
goslareddy@gmail.com