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Use of Aligners for malocclusion correction and to know if there is inflammatory biomarkers and Bis-phenol A and its effects on human health.

Phase 2
Not yet recruiting
Conditions
Those who seek malocclusion correction treatment and without any medical diseases.
Registration Number
CTRI/2025/04/084458
Lead Sponsor
Dr Padmapriya P
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Patients who are healthy without any medical conditions and congenital anomaly 2.
  • Patients who do not undergone previous orthodontic treatment or orthognathic surgeries.
Exclusion Criteria

NO OTHER SYSTEMIC DISEASES NO PERIODONTAL DISEASES NO OTHER MEDICAL DISEASES.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.30 days
Secondary Outcome Measures
NameTimeMethod
To compare the level of biomarkers & bisphenol A amounts between Outsourced & In house & Directly Printed Aligners30 days

Trial Locations

Locations (1)

Sri Sankara Dental Collage

🇮🇳

Thiruvananthapuram, KERALA, India

Sri Sankara Dental Collage
🇮🇳Thiruvananthapuram, KERALA, India
Dr Padmapriya P
Principal investigator
9074996021
drpriyadentcare@gmail.com

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