| CTRI Number |
CTRI/2014/08/004844 [Registered on: 08/08/2014] Trial Registered Prospectively |
| Last Modified On: |
21/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
a clinical trial to study the effects of 3 mouth rinses (aloe vera, chlorhexidine, chlorine dioxide)in patients undergoing dental braces treatment. |
|
Scientific Title of Study
|
EVALUATION OF ANTIPLAQUE AND ANTIGINGIVITIS EFFECT OF ALOE VERA, CHLORINE DIOXIDE AND CHLORHEXIDINE MOUTH RINSES: A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Y Sravan Kumar |
| Designation |
post graduate |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of Public Health Dentistry
Manipal College of Dental Sciences
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
09035646224 |
| Fax |
|
| Email |
drsravanmdsphd@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shashidhar Acharya |
| Designation |
Professor and Head of Department |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of Public Health Dentistry
Manipal College of Dental Sciences
Manipal Department of Public Health Dentistry
Manipal College of Dental Sciences
Manipal Udupi KARNATAKA 576104 India |
| Phone |
09448127031 |
| Fax |
|
| Email |
shashidhar_acharya@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Y Sravan Kumar |
| Designation |
post graduate |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of Public Health Dentistry
Manipal College of Dental Sciences
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
09035646224 |
| Fax |
|
| Email |
drsravanmdsphd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal college of dental sciences, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Sravan Kumar Y |
| Address |
dept of public health dentistry
manipal college of dental sciences
manipal |
| Type of Sponsor |
Other [principal investigator] |
|
|
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 Sravan Kumar Y |
manipal college of dental sciences |
Department of orthodontics,
PG division
Room no - 7
manipal college of dental sciences
manipal Udupi KARNATAKA |
9035646228
drsravanmdsphd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturaba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
gingivitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
aloe vera mouth rinse |
Indigenous preparation of Aloe vera mouth rinse of 50 ug/ml will be dispensed in amber coloured bottles.
route of administration is orally and for topical use only. clear instructions will be given to gargle not to swallow.
all the participants under study will use the respected mouth washes for 15 days twice daily (morning & night. |
| Comparator Agent |
chlorhexidine mouth rinse |
Commercially available 0.2% Chlorhexidine (Nitra hex, Micro Labs Limited, Bangalore, India) will be dispensed in amber coloured bottles.
route of administration is orally and for topical use only. clear instructions will be given to gargle not to swallow.
all the participants under study will use the respected mouth washes for 15 days twice daily (morning & night) |
| Intervention |
chlorine dioxide mouth rinse |
Commercially available 0.1% Chlorine dioxide (Freshchlor, Group Pharmaceuticals, Mumbai, India) will be dispensed in amber coloured bottles.
route of administration is orally and for topical use only. clear instructions will be given to gargle not to swallow.
all the participants under study will use the respected mouth washes for 15 days twice daily (morning & night) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients visiting Department of Orthodontics, Manipal College of Dental Sciences, Manipal.
2.Systemically healthy patients.
3.Subjects willing to participate. |
|
| ExclusionCriteria |
| Details |
1.Subjects with multiple restorations and gross dental caries on palatal, buccal and proximal surfaces.
2.Subjects under any form of topical or systemic antibiotic treatment during the past 2 weeks.
3.Subjects who are current users of tobacco in any form. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| anti plaque efficacy of Aloe vera, Chlorine dioxide and Chlorhexidine mouth rinses |
clinical evaluation will be done before and after 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| anti gingivitis efficacy of Aloe vera, Chlorine dioxide and Chlorhexidine mouth rinses |
clinical evaluation will be done before and after 15 days |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2014 |
| Date of Study Completion (India) |
30/12/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Periodontal diseases (gingivitis and periodontitis)
and dental caries are the two most prevalent oral infections affecting mankind
worldwide and plaque is the common etiological factor.
Plaque control is the basis and goal for prevention of gingivitis,
periodontitis and dental caries. However, complete plaque removal is difficult
to achieve and prevention can be achieved by reducing the quantity of plaque below
the threshold level for disease or changing the quality of plaque towards more
protective composition.
For effective plaque control,
several mechanical (tooth brushing and flossing) and chemical oral hygiene aids
are available. Among the various chemical antimicrobial agents available, Chlorhexidine
is considered as gold standard. Chlorhexidine can be used as mouth rinse or gel,
but has side effects such as staining of teeth and tongue, altered taste
sensation and increased calculus formation over prolonged usage.
Recently, the extracts or oils of
various medicinal plants having antimicrobial and anti-inflammatory activity
has been reported and used for prevention of various oral infections. Aloe
vera, is one such plant which was shown to have antimicrobial,
anti-inflammatory, antiulcer activity and astringent effect. Considering the beneficial effects along with ease of availability, cost and no
known adverse effects, Aloe vera can be a suitable alternative.
Recently a mouthwash containing Chlorine dioxide
(ClO2) has become available on the market. Oral rinses containing ClO2 are
utilized in dental practices as a topical antiseptic. Previous studies have
suggested that ClO2 is bactericidal to most of the periodontogenic microorganisms
and shown promising results. The presence of fixed appliances in
oral cavity for prolonged periods create favourable conditions for the
development of dental plaque by providing retentive surface which increases the
bacterial load. Hence, gingival inflammation and demineralization of enamel
occurs more frequently in orthodontic patients with poor oral hygiene. Hence, there is a need for products for regular maintenance of
acceptable oral hygiene without any adverse effects. Null Hypothesis: there is no difference in anti plaque and anti gingivitis efficacy of Aloe
vera, Chlorine dioxide and Chlorhexidine mouth rinses among patients undergoing
orthodontic treatment. |