| CTRI Number |
CTRI/2025/04/084458 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Aligners for malocclusion correction and to know if there is inflammatory biomarkers and Bis-phenol A and its effects on human health. |
|
Scientific Title of Study
|
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 Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Padmapriya P |
| Designation |
postgraduate student |
| Affiliation |
Sri Sankara Dental Colege |
| Address |
final year post graduate student
department of orthodontics and dentofacial orthopedics
sri sankara dental college
akathumuri varkala trivandrum
Dr padmapriya p
kaaralil house
kulikkiliyadu
karimpuzha post
palakkad kerala 679513
Palakkad
KERALA
695318
India |
| Phone |
9074996021 |
| Fax |
|
| Email |
drpriyadentcare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Krishnan |
| Designation |
professor and HOD |
| Affiliation |
Sri Sankara Dental College Trivandrum |
| Address |
department of orthodontics
sri sankara dental collage
varkala
trivandrum
Professor and HOD
department of orthodontics
sri sankara dental collage
679513
Thiruvananthapuram
KERALA
695318
India |
| Phone |
9447310025 |
| Fax |
|
| Email |
vikrishnan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Krishnan |
| Designation |
Professor and HOD |
| Affiliation |
sri sankara dental collage |
| Address |
Department of Orthodontics
Sri Sankara Dental Collage
Akathumuri
Varkala
Thiruvananthapuram
KERALA
695318
India |
| Phone |
9447310025 |
| Fax |
|
| Email |
vikrishnan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Padmapriya P
Sri Sankara Dental Collage
Akathumuri
Varkala
695318 |
|
|
Primary Sponsor
|
| Name |
Dr Padmapriya P |
| Address |
Sri Sankara Dental College
Akathumuri
Varkala
Trivandrum 695318 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Padmapriya P |
Sri Sankara Dental Collage |
3rd floor
department of orthodontics
sri sankara dental collage
Akathumuri
Varkala
695318
Thiruvananthapuram
KERALA |
9074996021
drpriyadentcare@gmail.com |
|
|
Details of Ethics Committee
|
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Those who seek malocclusion correction treatment and without any medical diseases. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aligner Therapy |
Aligners are given for mild malocclusion correction and saliva and gingival crevicular fluids are collected to know about the levels of inflammatory biomarkers and bisphenol A levels |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are healthy without any medical conditions and congenital anomaly
2. Patients who do not undergone previous orthodontic treatment or orthognathic surgeries |
|
| ExclusionCriteria |
| Details |
NO OTHER SYSTEMIC DISEASES
NO PERIODONTAL DISEASES
NO OTHER MEDICAL DISEASES |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| To compare the level of biomarkers & bisphenol A amounts between Outsourced & In house & Directly Printed Aligners |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |