NCT06456827 ''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 ID | NCT06456827 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak |
| Condition | Relapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-25 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-12-25 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06456827 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Relapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06456827 currently recruiting?
Yes, NCT06456827 is actively recruiting participants. Contact the research team at mk3pgids@gmail.com for enrollment information.
Where is the NCT06456827 trial being conducted?
This trial is being conducted at Rohtak, India.
Who is sponsoring the NCT06456827 clinical trial?
NCT06456827 is sponsored by Postgraduate Institute of Dental Sciences Rohtak. The trial plans to enroll 40 participants.