''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 ''
NCT Number: NCT06456827
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Relapse|Bite Force|Biomarker
Interventions: OTHER: bite force and gcf in horizontal grower and vertical grower
Sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06
Completion Date: 2026-08
Locations: Dr Rekha, Rohtak, Haryana, 124001, India

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.

Primary Outcome Measures: 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 Outcome Measures: - changes in change in levels of bone turnover markers, 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, 12 months