A comparative evaluation of gingival crevicular fluid & salivary biomarkers & bisphenol A level with outsourced, inhouse and direct printed aligner for orthodontic tooth movement an invivo study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To find assosciation between salivary inflammatory biomarkers and Bis phenol A levels among different types of aligners used for tooth movement and its implications on health in South Kerala populations.
Study Overview
Brief Summary
This comparative in vivo study was conducted to determine if there is any difference in the level of expression of inflammatory biomarkers such as IL-1 beta, TNF alpha as well as Bis-phenol A (BPA) release when different types of aligners are used in similar malocclusion on randomly selected 60 participants attending the out-patient clinic of Department of Orthodontics and Dentofacial Orthopedics, Sri Sankara Dental Collage, Varkala , Trivandrum.
BPA is a known endocrine disrupter. BPA increases the risk of cancer, diabetes, heart disease and hyperactivity in children. The collected GCF samples were transferred to 0.5 ml Eppendorf tubes and analysed using high performance liquid chromatography - mass spectrometry. As well as 10 ml of saliva is collected into polypropylene tubes with protease inhibitors and ELIZA was used to screen the sample for cytokines. The harmonious interplay of osteoclast differentiation and cytokine activation is fundamental to the success of bone remodelling, ultimately ensuring effective and controlled tooth movement. So by conducting this study we can improve the treatment efficiency and can reduce the unwanted side effects caused by BPA.
Study Design
- Study Type
- Interventional
- Allocation
- Adaptive randomization, such as minimization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 26.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients who are healthy without any medical conditions and congenital anomaly
- •Patients who do not undergone previous orthodontic treatment or orthognathic surgeries.
Exclusion Criteria
- •NO OTHER SYSTEMIC DISEASES NO PERIODONTAL DISEASES NO OTHER MEDICAL DISEASES.
Outcomes
Primary Outcomes
To find assosciation between salivary inflammatory biomarkers and Bis phenol A levels among different types of aligners used for tooth movement and its implications on health in South Kerala populations.
Time Frame: 30 days
Secondary Outcomes
- To compare the level of biomarkers & bisphenol A amounts between Outsourced & In house & Directly Printed Aligners(30 days)