| CTRI Number |
CTRI/2018/02/011847 [Registered on: 12/02/2018] Trial Registered Prospectively |
| Last Modified On: |
08/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of two mouthrinses in orthodontic patients |
|
Scientific Title of Study
|
Comparative Evaluation of Anti inflammatory effect of Aloevera mouthrinse with Chlorhexidine in fixed orthodontic patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nadimpalli Harshita |
| Designation |
2nd year post graduate |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room no:4,Department of Periodontology,Light house hill Road,Hampankatta.
Room no:4,Department of Periodontology,Light house hill Road,Hampankatta.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8904934890 |
| Fax |
|
| Email |
harshithaverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa G Kamath |
| Designation |
Professor and HOD |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room no:4,Department of Periodontology,Light house hill Road,Hampankatta.
Room no:4,Department of Periodontology,MCODS,Attavar.Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448454788 |
| Fax |
|
| Email |
deepa.gkamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Nadimpalli Harshita |
| Designation |
2nd year post graduate |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room no:4,Department of Periodontology,Light house hill Road,Hampankatta.
Room no:4,Department of Periodontology,Light house hill Road,Hampankatta.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8904934890 |
| Fax |
|
| Email |
harshithaverma@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nadimpalli Harshita |
| Address |
Room no:4,Department of Periodontology,Light house hill Road,Hampankatta. |
| Type of Sponsor |
Other [Principal Investigator(Nadimpalli Harshita)] |
|
|
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 |
| Nadimpalli Harshita |
Manipal College of Dental Sciences |
Room no:4,Department of Periodontology,Light house hill Road,Hampankatta,Mangalore
Dakshina Kannada
KARNATAKA |
8904934890
harshithaverma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
gingivitis in fixed orthodontic appliance patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aloevera solution |
Aloevera solution 10ml for 1min twice daily for 21 days after 1st visit |
| Comparator Agent |
chlorhexidine |
0.2% chlorhexidine 10ml for 1 minute twice daily for 21 days after 1st visit |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Systemically healthy participants with 20 natural teeth with 5 teeth per quadrant;
2) Patients with fixed orthodontic appliances who are under regular oral hygiene maintenance |
|
| ExclusionCriteria |
| Details |
1)Probing pocket depth >3 mm,
(2) Antimicrobial therapy 1 month prior to the study;
(3) Using dentifrices or mouth rinses with anti-inflammatory properties;
(4) Smokers and tobacco consumers
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival index |
baseline,21 days,45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| plaque index,bleeding on probing |
baseline,21 days,35 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
14/02/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the our study is to evaluate the effect of aloevera mouthrinse on gingival health in fixed orthodontic patients comparision with chlorhexidine in 30 patients who are selected based on inclusion and exclusion criteria.These patients are divided into two groups(aloevera group and chlorhexidine group),15 in each group.Each patient will be evaluated in three visits(baseline-1st visit,after 3weeks of use-2nd visit,at the 2nd visit pt will be asked to stop using mouthwash,recall after 2weeks-3rd visit) for periodontal parameters such as gingival index,plaque index,bleeding on probing.Previous studies have reported that the effect of aloevera mouthwash was same as chlorhexidine on gingivitis,but none of those studies were done on orthodontic patients. |