a study to understand the role of nutritional food supplements(collagen) in growing children for management of skeletal malformations of lower jaws
- Conditions
- Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified
- Registration Number
- CTRI/2023/08/056423
- Lead Sponsor
- itta Gelatin india limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion criteria Patients were selected using the following inclusion criteria:
a)Angles class II molar relation
b)Skeletal Class II Division 1 malocclusion resulting from mandibular retrognathia (Reduced SNB angle 73°-78°).
c)Growing children between 9-14 years having positive Visual treatment objective (VTO)
d)The sagittal skeletal discrepancy angle (ANB angle) above 4. °
e)Patientsâ?? Lateral Cephalograms will be used to assess the growth status of the patients. CVMI Stage 3,4 will be included in the study.
f)Patients having non-vegetarian dietary habits will be included in the study (collagen is of animal origin).
Patients with bone disease, metabolic disease, hepatic, renal or thyroid malfunction, intake of drugs that could affect bone metabolism, and fluctuating dietary patterns. People with known allergy to fish products will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The aim of the study was to investigate the influence of dietary intake of Collagen and calcium on condylar bone remodelling in children undergoing mandibular advancement. Assessment and comparison of the bone volume of mandibular condylar using CBCT images in the three groups at T0, T6 AND T12 will give idea about the treatment effects of nutritional supplementation. <br/ ><br>2. To assess the overall improvement and changes in the dental and skeletal parameters Cephalometrically in the twin block group and nutritionally supplemented Twinblock groups at T0, T6, T12. <br/ ><br>Timepoint: pretreatment,at 6 month and at 12 month
- Secondary Outcome Measures
Name Time Method 1.To correlate the IGF-1,Calcium,Osteoprotegren ,Alkaline Phosphatase,Acid Phosphatase, Levels at T0,T6,T12 with dietary intake and mandibular condyle bone volume changes ,mandibular condyle bone density changes following functional appliance treatment with twin block and nutritional supplements.Timepoint: pretreatment,at 6 month and at 12 month