Comparative effects of Preformed and conventional Lab based oromyofacial appliances on oral dysfunction and dentofacial growth during mixed dentition period: a randomised controlled study

INTERVENTION: Intervention1: Preformed Orofacial myotherapy Appliances (POMA): Prefabricated Orofacial myofunctional appliance treatment system in mixed dentition can intercept abnormal breathing patterns and relieve the signs of undergrowing jaw bones Intervention2: Preformed Orofacial myotherapy Appliances: Will be given for minimum period of 6 months upto maximum of 18 months duration Control Intervention1: Lab‐based Orofacial Myotherapy Appliance : Lab‐based Orofacial Myotherapy Appliance treatment system intercepts abnormal breathing patterns in growing children Control Intervention2: Lab based oromyofacial appliances: Will be given for a minimum of 6 months upto maximum of 18 months duration CONDITION: Health Condition 1: K088‐ Other specified disorders of teethand supporting structures PRIMARY OUTCOME: Change in Nasal Breathing efficiencyTimepoint: at 6 months, 12 months, 18 months SECONDARY OUTCOME: Change in growth parameters of maxilla and mandible:Timepoint: at 6 months, 12 months, 18 months Change in orthodontic treatment needs: This shall be assessed using inde Xfor preventive and interceptive orthodontic need (IPION)Timepoint: at 6 months, 12 months, 18 months Change in Postural parameters:Timepoint: at 6 months, 12 months, 18 months Change in swallowing patternTimepoint: at 6 months, 12 months, 18 months Change in tongue position production of the sounds:Timepoint: at 6 months, 12 months, 18 months Change in tongue posture:Timepoint: at 6 months, 12 months, 18 months INCLUSION CRITERIA: Children with any of the following signs of insufficient nasal breathing efficiency: 1. Breath holding time less than 25 seconds 2. Takes one minute or more to complete 10 breaths 3. Forward head posture as determined with New York test for postural assessment8 4. Hypertonic mentalis/buccinator muscles on evident on soft tissue evaluation while swallowing 5. Children at stage Cervical maturation stages 3 and 4 as observed on lateral cephalogram