| CTRI Number |
CTRI/2025/04/084077 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Microbial adhearance on Different Stainless Steel Brackets |
|
Scientific Title of Study
|
Microbial Colonisation on Different Commercially Available Stainless Steel Orthodontic Brackets: A Clinical 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 |
AVANI JHA |
| Designation |
PG STUDENT |
| Affiliation |
SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ORTHODONTICS, SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES, RAIBAREILY ROAD, LUCKNOW
Lucknow
UTTAR PRADESH
226024
India |
| Phone |
6360050894 |
| Fax |
|
| Email |
AVANI.JHA25@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
VAIBHAV VASHISHTA |
| Designation |
PROFESSOR |
| Affiliation |
SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ORTHODONTICS, SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES, RAIBAREILY ROAD, LUCKNOW
Lucknow
UTTAR PRADESH
226024
India |
| Phone |
9792712345 |
| Fax |
|
| Email |
drvaibhavvashishta@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
AVANI JHA |
| Designation |
PG STUDENT |
| Affiliation |
SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES |
| Address |
SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES, RAIBAREILY ROAD, LUCKNOW
UTTAR PRADESH
226024
India |
| Phone |
6360050894 |
| Fax |
|
| Email |
AVANI.JHA25@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Room No. 6, DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES, LUCKNOW
INDIA
226002 |
|
|
Primary Sponsor
|
| Name |
SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES |
| Address |
SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES |
| Type of Sponsor |
Other [PRIVATE DENTAL COLLEGE] |
|
|
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 AVANI JHA |
SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES |
ROOM NO. 6, THIRD FLOOR,DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS,SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES, LUCKNOW 226024
Lucknow
UTTAR PRADESH |
6360050894
AVANI.JHA25@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONA ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
USED ORTHODONTIC BRACKETS WILL BE COLLECTED FROM HEALTHY PATIENTS COMING TO THE DEPARTMENT FOR ORTHODONTIC TREATMENT |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
I. Patients between age group 13-25 years.
II. Complete permanent dentition except third molars with no missing or supernumerary teeth.
III. Bimaxillary protrusion cases with minimal crowding, planned for all first premolar extraction
IV. Patient oral cavity should be (OHI-S:fair) grading before the start of the study and the patient should be motivated for good oral hygiene while undergoing fixed orthodontic treatment with standardized MBT 0.022X0.028 slot.
V. No active carious lesion should be present.
VI. The type of ligation, arch wire and bonding material are constant.
|
|
| ExclusionCriteria |
| Details |
I. Decalcification or increased risk to caries (high caries index)
II. Use of antibiotics during the three-month period.
III. Halitosis and poor periodontal status
IV. Subjects having systemic disease
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WE KNOW THAT ORTHODONTIC BRACKETS ARE A SITE FOR BACTERIAL AND PLAQUE ACCUMULATION |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WE CAN ASSESS WHICH COMMERCIALLY AVAILABLE STEEL ORTHODONTIC BRACKET HOSTS THE LEAST AMOUNT OF BACTERIAL COLONIES |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/04/2025 |
| Date of Study Completion (India) |
10/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Specific alterations take place in the oral environment because of fixed orthodontic treatment. There is an increased accumulation of plaque, an increase in the count of microorganisms, and a decrease in the level of pH, which leads to an increased risk of caries and periodontal diseases. The formation of the biofilm could be influenced by the placement of the orthodontic brackets. The oral health and the relationship between oral health status during and after orthodontic treatment is a big challenge. Orthodontic bracket serves as a site for plaque accumulation. The microbial plaque retention also depends on the method of ligation. Elastic or stainless-steel ligatures, which are used for holding the wire onto the brackets, contribute to the retention of supragingival plaque. |