Evaluating bite force and bone turnover markers in orthodontic patients with different growth patterns
''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 ''
This study is testing how bite force and certain bone markers change in young adults after orthodontic treatment, comparing those with different growth patterns in their jaws.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak Academic / other |
| Locations | 1 site (Rohtak, Haryana) |
| Trial ID | NCT06456827 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the changes in bite force and levels of bone turnover markers (CTX and BALP) in patients who have completed fixed orthodontic treatment, categorized into two groups based on their craniofacial growth patterns: hyperdivergent and hypodivergent. The study will be conducted in a single-blind, two-arm parallel design, where patients will be monitored for changes in bite force and biomarker levels over time. The sample size is calculated to include 20 non-growing patients aged 18-25, ensuring optimal occlusion and periodontal health. Data will be collected at multiple time points to assess the retention characteristics of dentition post-treatment.
Who should consider this trial
Good fit: Ideal candidates are non-growing patients aged 18-25 who have completed fixed orthodontic treatment with specific growth patterns.
Not a fit: Patients with incomplete orthodontic treatment, TMJ disorders, or systemic diseases affecting bone growth may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing retention strategies for orthodontic patients, potentially reducing relapse rates.
How similar studies have performed: While there are existing studies on bite force and orthodontic retention, this specific comparative approach focusing on growth patterns is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rohtak, Haryana
- Dr Rekha — Rohtak, Haryana, India (Recruiting)
Study contacts
- Study coordinator: Dr manisha kukreja, MDS
- Email: mk3pgids@gmail.com
- Phone: 9215650617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.