a study to understand the role of nutritional food supplements(collagen) in growing children for management of skeletal malformations of lower jaws

Comparison of Treatment outcomes of Functional appliance therapy with and without Nutritional Supplementation in growing children with Skeletal Class II malocclusion -A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056423

Enrollment

Registered

2023-08-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified

Interventions

Intervention1: Nurtritional supplementation with Collagen during mandibular advancement with Twin block appliance: Twin block functional appliance for 8-10 hours daily wear for 6 months along with foo

Eligibility

Inclusion criteria

Inclusion criteria: 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 73Â°-78Â°). c) Growing children between 9-14 years having positive Visual treatment objective (VTO) d) The sagittal skeletal discrepancy angle (ANB angle) above 4. Â° 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).

Exclusion criteria

Exclusion criteria: Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. 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. Timepoint: pretreatment,at 6 month and at 12 month	—

Measure

Time frame

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. 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. Timepoint: pretreatment,at 6 month and at 12 month

—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Poonam Kumari Jayaprakash

Rajendra Institute of medical sciences,Ranchinchi

drpoonamjportho@gmail.com08618342083

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026