| CTRI Number |
CTRI/2024/09/074517 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study of the underlying
changes in bone when tooth movement is brought about by orthodontic treatment |
|
Scientific Title of Study
|
Clinical implications of biological markers of orthodontic tooth movement (OTM) using two different aligners |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Lakshmanan |
| Designation |
post graduate student |
| Affiliation |
Ragas Dental College and Hospital, |
| Address |
Department of Periodontics,
Ragas Dental College and Hospital,
2/102, East Coast Road,
Uthandi,
Chennai
Chennai
TAMIL NADU
600119
India |
| Phone |
8072510279 |
| Fax |
|
| Email |
poojayoona1197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BShivakumar |
| Designation |
Professor and Head |
| Affiliation |
Ragas Dental College and Hospital, |
| Address |
Department of Periodontics,
Ragas Dental College and Hospital,
2/102, East Coast Road,
Uthandi,
Chennai
Chennai
TAMIL NADU
600119
India |
| Phone |
9840479181 |
| Fax |
|
| Email |
shivabaskaran@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BShivakumar |
| Designation |
Professor and Head |
| Affiliation |
Ragas Dental College and Hospital, |
| Address |
Department of Periodontics,
Ragas Dental College and Hospital,
2/102, East Coast Road,
Uthandi,
Chennai
Chennai
TAMIL NADU
600119
India |
| Phone |
9840479181 |
| Fax |
|
| Email |
shivabaskaran@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Ragas dental college and hospital - Infrastructural support |
|
|
Primary Sponsor
|
| Name |
Pooja Lakshmanan |
| Address |
Room No:6,Department of periodontics,Ragas dental college and hospital,2/102,, SH 49, Uthandi, Tamil Nadu 600119 |
| Type of Sponsor |
Other [SELF FUNDED ] |
|
|
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 Pooja Lakshmanan |
Ragas Dental College and Hospital |
Room no:6,Department of periodontics,Ragas dental college and hospital,2/102, East Coast Road,
Uthandi,
Chennai-600119
Chennai
TAMIL NADU |
8072510279
poojayoona1197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, RAGAS DENTAL COLLEGE AND HOSPITAL |
Approved |
| RAGAS DENTAL COLLEGE AND HOSPITAL |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
orthodontic treatment for maloscclusion by CPA Graphy |
Patients with malocclusion are treated with Graphy aligners, and bone remodeling will be assessed at 7, 14, 21, 28, and 42 days. |
| Intervention |
orthodontic treatment for maloscclusion by CPA Invisalign |
Patients with malocclusion are treated with Invisalign aligners, and bone remodeling will be assessed at 7, 14, 21, 28, and 42 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Periodontally healthy adult patients who require orthodontic treatment.
2.Those patients who meet the criteria to be treated by aligners in the age group of 20 -40 years |
|
| ExclusionCriteria |
| Details |
1.Patients who have taken any drugs that might alter bone metabolism in the last 6 months.
2.Patients with systemic conditions viz. DM, Hypertension etc. and known allergy.
3.Pregnant/ lactating women.
4.Smokers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the level of biomarkers at various time points of the othodontic treatment |
7,14,21,28 and 42 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the tooth movement at various time points of the orthodontic treatment |
7,14,21,28 & 42 DAYS |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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
|
Induction of biologically active compounds occur inside the periodontium during orthodontic tooth movement (OTM).
The spatiotemporal events that happen during OTM can be assessed / illustrated by evaluation of these and hence known
as biomarkers.
Biomarkers are quantifiable criteria of biological processes that provide indications objectively. During the orthodontic
procedure, the analysis of saliva and gingival crevicular fluid (GCF) may be examined to monitor biological
process/progress. They also have the features of specificity and sensitivity which would correlate objectively with the
biological events that occur during OTM.
Adequate knowledge about the cellular and biological processes makes it easier to understand the biological mechanics
that can shorten the treatment time avoiding the detrimental effects linked to the orthodontic treatment due to its
objective characteristics. Does orthodontic forces with the two different aligner systems impact bone
remodeling differentially ? |