''Comparative Evaluation of Change in Bite Force and Levels of Bone Turnover Markers CTX and BALP in Hyperdivergent and Hypodivergent Cases During Retention Phases-A Prospective Clinical Trial ''

NCT06456827 | Recruiting

• 1 other identifier: Dr Aaliya
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Long-term studies have shown that various occlusal changes occur after the active phase of orthodontic treatment. some of these changes are unwanted changes and are considered as relapse The retention appliances are used to maintain the arch dimensions and alignment of the teeth after completion of the orthodontic treatment. One indicator of the functional state and health of the masticatory system is maximum voluntary bite force (MVBF). Its values vary in accordance to the location of measurement (highest at the first molar, lower at the incisors). People with pronounced horizontal craniofacial growth have somewhat higher values of MVBF, and those with vertical growth have lower values than do those with an average growth pattern. Clinical case reports and descriptive histologic data exist suggesting that bone and tooth remodeling persist for extended periods after removal of appliance or deactivation. A reflection of bone remodelling can be found in the gingival crevicular fluid (GCF) of moving teeth, with decrease or increase in the concentration of biomarker. This prompted us to evaluate the expression of variation in bone turnover marker levels (CTX-Bone resorption marker and BALP -Bone formation marker ) during the retention period. The International Osteoporosis Foundation (IOF) and International Federation of Clinical Chemistry (IFCC) have recommended C-terminal telopeptide of type I collagen (CTX) as one of the reference for BTMs. Hence, The present trial will be undertaken to assess the changes and compare if there is any difference in bite force and change in level of bone biomarker biomarker CTX type 1 collagen(C-terminal telopeptide of type I collagen and bone specific alkaline phosphatase(BALP) in post orthodontic treatment hypodivergent and hyperdivergent cases using beggs retainer over 12 months of period of retention.

Conditions

Relapse; Bite Force; Biomarker

Keywords

CTX and BALP biomarker , Bite force

Outcome Measures

Primary Outcomes (1)

• change in bite force will be measured by bite force measuring device

  change in bite force will be measured by bite force measuring device at, T0(at the time of retainer delivery), T1(1 month of retainer delivery), T2(3 months of retainer delivery) and T3 (6 months of retainer delivery) ,T4 (12 months of retainer delivery) time interval.

  12 months

Secondary Outcomes (1)

• - changes in change in levels of bone turnover markers

  12 months

Study Arms (2)

vertical grower

OTHER

Patients belonging to group 1 will be patient with vertical growth pattern who have undergone fixed orthodontic cases and are ready for debonding with FMA of 26 0 or more. Begg's Retainer will be formed by conventional method and delivered within 24 hours of debonding. Changes in levels of bone turnover markers CTX-bone resorption and BALP-bone formation using ELISA and compare the bite force

Other: Bite force and Gcf

Horizontal grower

OTHER

Patients belonging to group 2 will be patient with horizontal growth pattern who have undergone Fixed orthodontic cases and are ready for debonding with with FMA Of 24 o or less.Changes in levels of bone turnover markers CTX-bone resorption and BALP-bone formation using ELISA and compare the bite force

Other: Bite force and Gcf

Interventions

Bite force and Gcf OTHER

change in bite force will be measured by bite force measuring device at, T0(at the time of retainer delivery), T1(1 month of retainer delivery), T2(3 months of retainer delivery) and T3 (6 months of retainer delivery) ,T4 (12 months of retainer delivery) time interval. Changes in the following parameters - changes in change in levels of bone turnover markers CTX and BALP using ELISA at T0(at the time of retainer delivery), T1(1 month of retainer delivery), T2(3 months of retainer delivery) and T3 (6 months of retainer delivery) ,T4 (12 months of retainer delivery) time interval

Horizontal grower; vertical grower

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non - growing (18-25) patients who had finished Fixed orthodontic cases ( ready for debonding )with FMA of 26 or more for hyperdivergent cases and FMA of 24 or less for hypodivergent cases
• Optimal functional occlusion at end of treatment (PAR score \>70%).
• Littles irregularity index (Pre-treatment \<6mm in both upper and lower arch).
• Nonsurgical and non-orthopedic patients and non syndromic patients.
• Optimal periodontal condition and Good oral hygiene (probing depth \<3mm, gingival index score \<1
• Good compliance regarding retainer wear

You may not qualify if:

• Subjects with incomplete orthodontic treatment.
• TMJ disorder patients.
• Any systemic disease affecting bone and general growth.
• Patients with incomplete records.
• Patient who fail to follow up or undergo complete treatment.
• Patient with learning difficulties
• Patients having antibiotic therapy within previous 3 months and used anti -inflammatory drugs in the month before the study

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Dr Rekha

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Recurrence; Xanthomatosis, Cerebrotendinous

Interventions

Bite Force

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Xanthomatosis

Intervention Hierarchy (Ancestors)

Dental Occlusion; Dentistry

Central Study Contacts

Dr manisha kukreja, MDS

CONTACT

9215650617; mk3pgids@gmail.com

Dr Aaliya khan

CONTACT

9711549786; draaliyakha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: June 13, 2024
• Study Start: December 25, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)