| CTRI Number |
CTRI/2025/02/080010 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing the effectiveness of three different cleaning methods for orthodontic aligners |
|
Scientific Title of Study
|
EVALUATION OF EFFICACY OF THREE DIFFERENT CLEANSING METHODS ON ORTHODONTIC ALIGNERS
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 |
Shaik yaseen |
| Designation |
Post graduate student |
| Affiliation |
St. joseph dental college and hospital |
| Address |
Department of orthodontics and dentofacialorthopaedics,
st.joseph dental college and hospital ,duggirala,eluru
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
7032184979 |
| Fax |
|
| Email |
shaikhyaseenajaz99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ch hanumantha rao |
| Designation |
Reader |
| Affiliation |
St. joseph dental college and hospital |
| Address |
Department of orthodontics and dentofacial orthopaedics ,st.joseph dental college and hospital,duggirala,eluru
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9985852792 |
| Fax |
|
| Email |
Orthosmile1755@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ch hanumantha rao |
| Designation |
Reader |
| Affiliation |
St. joseph dental college and hospital |
| Address |
Department of orthodontics and orthopaedics, st.joseph dental college and hospital, duggirala, eluru
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9985852792 |
| Fax |
|
| Email |
Orthosmile1755@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthodontics and dentofacial orthopaedics, st joseph dental college and hospital, eluru |
|
|
Primary Sponsor
|
| Name |
Shaik yaseen |
| Address |
Department of orthodontics and dentofacial orthopaedics,st. joseph dental college and hospital,duggirala,eluru, 534003 INDIA |
| 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 Shaik yaseen |
St joseph dental college |
Department of orthodontics and dentofacial orthopaedics ,st. joseph dental college and hospital, duggirala,eluru
West Godavari
ANDHRA PRADESH |
07032184979
shaikhyaseenajaz99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sjdc institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K036||Deposits [accretions] on teeth, (2) ICD-10 Condition: Z138||Encounter for screening for otherspecified diseases and disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparision of mechanical, chemical, both mechanical and chemical cleansing methods on
orthodontic aligners |
Evaluation of efficacy of three different cleansing methods on orthodontic aligners |
| Intervention |
Different cleansing methods are mechanical,chemical and combination of mechanical and chemical method |
mechanical method by brushing,
chemical method by rexidine and combination of both mechanical and chemical method , duration of time 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
Sealed sheets
Patients with malocclusion of IOTN Index (Grade II)
Age group 16-25 years (male and female
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
Opened package received from manufacturer before microbial evaluation.
Damaged or deformed Sheets
Discoloured sheets
Mentally challenged patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 4 weeks |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
08/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/02/2025 |
| 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
|
| Aim of the study: To evaluate and compare the efficacy of three different cleansing methods on orthodontic aligners. By using three different cleansing methods like mechanical (brushing), chemical (Rexidine), and combination of both mechanical and chemical methods. Patients coming to the OPD of the department of orthodontics and dentofacial orthopaedics of St Joseph dental college, Duggirala, Eluru will be taken for the study. Inclusion Criteria includes, Sealed sheets, Patients with malocclusion of IOTN Index (Grade II) , Age group 16-25 years (male and female). Exclusion Criteria includes, Opened package received from manufacturer before microbial evaluation, Damaged or deformed Sheets, Discoloured sheets, Mentally challenged patients. In this Study, evaluation of colony forming units (CFU) of different bacteria on orthodontic aligners sheets at different duration of time.The results will be statistically analyzed
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