| CTRI Number |
CTRI/2024/12/078161 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Interleukin 6 Levels in Gingival Fluid-Comparing One-Week and Two-Week Aligner Wear |
|
Scientific Title of Study
|
QUANTITATIVE ANALYSIS OF INTERLEUKIN- 6 IN GINGIVAL
CREVICULAR FLUID: A COMPARATIVE CLINICAL STUDY OF ONE WEEK VERSUS TWO
WEEK ALIGNER WEAR PROTOCOL |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Merliya John |
| Designation |
PG Trainee |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL CUTTACK |
| Address |
Dept Of Orthodontics and Dentofacial Orthopedics
SCB Dental College
Manglabag
Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9744094503 |
| Fax |
|
| Email |
liyajo13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SURYA KANTA DAS |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL CUTTACK |
| Address |
DEPT OF ORTHODONTICS DENTOFACIAL ORTHOPEDICS
SCB DENTAL COLLEGE
MANGLABAG
CUTTACK
Cuttack
ORISSA
753007
India |
| Phone |
9861099237 |
| Fax |
|
| Email |
orthosuryakantadas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SURYA KANTA DAS |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL CUTTACK |
| Address |
DEPT OF ORTHODONTICS DENTOFACIAL ORTHOPEDICS
SCB DENTAL COLLEGE
MANGLABAG
CUTTACK
ORISSA
753007
India |
| Phone |
9861099237 |
| Fax |
|
| Email |
orthosuryakantadas@gmail.com |
|
|
Source of Monetary or Material Support
|
| SCB DENTAL COLLEGE AND HOSPITAL
CUTTACK
ODISHA
INDIA
PIN 753007 |
|
|
Primary Sponsor
|
| Name |
MERLIYA JOHN |
| Address |
DEPT OF ORTHODONTICS
SCB DENTAL COLLEGE
CUTTACK
ODISHA
INDIA
PIN 753007 |
| Type of Sponsor |
Other [SELF SPONSOR] |
|
|
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 MERLIYA JOHN |
SCB DENTAL COLLEGE AND HOSPITAL |
DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS
SECOND FLOOR NEW ANNEXURE BUILDING
CUTTACK
Cuttack
ORISSA |
9744094503
liyajo13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SCBDCH Cuttack |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP 1 SUBJECTS WITH ONE WEEK ALIGNER WEAR PROTOCOL |
ASSESSMENT OF INTERLEUKIN 6 LEVEL IN GCF OF SUBJECTS WITH ONE WEEK ALIGNER WEAR PROTOCOL |
| Comparator Agent |
GROUP 2 SUBJECTS WITH TWO WEEK ALIGNER WEAR PROTOCOL |
ASSESSMENT OF INTERLEUKIN 6 LEVEL IN GCF OF SUBJECTS WITH TWO WEEK ALIGNER WEAR PROTOCOL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients who had no history of previous orthodontic treatment.
2)Good control of oral hygiene.
3)No anti-inflammatory or antibiotic therapy in the previous 6 months.
4)Adult patients who are compliant for CAT.
5)Patient with no periodontal disease
5)Permanent dentition excluding third molars
6) Patient with no systemic disease
7)Patient with good posterior occlusion.
|
|
| ExclusionCriteria |
| Details |
1)Smoking habit
2)Signs of gingivitis and periodontitis
3)Caries or restoration in anterior teeth
4) Autoimmune disease
5)Pregnant and lactating patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the change in expression of IL-6 in subjects with one-week aligner wear
protocol and two-week aligner wear protocols at different time intervals |
To assess the change in expression of IL-6 in subjects with one-week aligner wear
protocol and two-week aligner wear protocols at different time intervals |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To obtain the gingival status of patients at the beginning of treatment and after one
month of CAT.
To assess the pain perception towards two different aligner wear protocol
aligners. |
before aligner placement and after 28 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2024 |
| 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="1"
Months="0"
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
|
According to orthodontic literature (IL-6) is a proinflammatory cytokine that is expressed in GCF, which controls the bone remodeling process through interactions with different types of bone cells. IL-6 is believed to play a positive regulatory role in osteoclast differentiation by inducing the expression of receptor activator of NF- kappa B ligand (RANKL) on the surface of osteoblasts . When orthodontic pressures are applied, IL-6 expression in the periodontal tissue increases . There are many research that has examined the expression of interleukin-6 in PDL and GCF, in patient following a fixed orthodontic treatment regimen.In CAT two week change protocol was widely used worldwide, until recent times when the one-week aligner protocol is been practiced. There have been many clinical studies comparing the accuracy of tooth movements in 7 days,10 days, and 14 days wear protocol which concluded that all three groups showed similar tooth movement and pain perception even though slight variation existed depending on the type of tooth movement.Studies have proven that up and down-regulation of cytokines depends on the amount of force given and it also diminishes differently in patients wearing clear aligners and fixed orthodontic treatment. Limited studies were conducted which evaluated the expression of different cytokines including IL-6 in the GCF of patients following a one-week aligner wear protocol. No comparative study between one-week and two-week aligner wear protocol has been done based on changes in the expression of cytokine brought about by clear aligners, making it difficult to evaluate the correct change in protocol and the effectiveness of these appliances.Therefore, it is crucial to reevaluate the molecular and biological basis for updating clear aligners wear protocol. The purpose of the study is to quantify the level of IL-6 in GCF in patients following two different aligner wear protocols and to correlate the results for redesigning the wear protocol. |