| CTRI Number |
CTRI/2020/06/026131 [Registered on: 25/06/2020] Trial Registered Prospectively |
| Last Modified On: |
03/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Black catechu extract as mouthwash in treatment of gingivitis |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of Acacia catechu willd and Chlorhexidine as mouthwash on Gingivitis- A clinicomicrobiological study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bindu James |
| Designation |
Post Graduate student Department of Periodontics |
| Affiliation |
Sri Hasanamba Dental College and Hospital |
| Address |
Sri Hasanamba Dental College and Hospital
Vidyanagar
Hassan
Hassan
KARNATAKA
573202
India |
| Phone |
8317468804 |
| Fax |
|
| Email |
bindujamesbj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vivekananda M R |
| Designation |
professor |
| Affiliation |
Sri Hasanamba Dental College and Hospital |
| Address |
Sri Hasanamba Dental College and Hospital
Vidyanagar
Hassan
Hassan
KARNATAKA
573202
India |
| Phone |
9980843531 |
| Fax |
|
| Email |
vivekcodsperio@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
vivekananda M R |
| Designation |
professor |
| Affiliation |
Sri Hasanamba Dental College and Hospital |
| Address |
Sri Hasanamba Dental College and Hospital
Vidyanagar
Hassan
Hassan
KARNATAKA
573202
India |
| Phone |
9980843531 |
| Fax |
|
| Email |
vivekcodsperio@ymail.com |
|
|
Source of Monetary or Material Support
|
| Sri Hasanamba Dental College and Hospital
Vidyanagar
Hassan |
|
|
Primary Sponsor
|
| Name |
Sri Hasanamba Dental College |
| Address |
Vidyanagar
Hassan
karnataka 573202 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| vivekananda M R |
Department of periodontics sri hasanamba dental college vidyanagar. |
sri hasanamba dental college
vidyanagar.
Hassan
KARNATAKA |
9980843531
vivekcodsperio@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acacia catechu mouthwash |
Acacia catechu(Khadir) belonging to Family Fabaceae echibits various pharmacological effects like anti-inflammatory, anti-diarrhoeal, hypoglycemic, antioxidant, hepatoprotective, antibacterial, antipyretic, antimicrobial, anticancer and antisecretory activities, helps in wound healing and sore throat etc. 5ml of Acacia catechu mouthwash twice daily for 15 days. |
| Comparator Agent |
Chlorhexidine gluconate 0.2% mouthwash |
Chlorhexidine is a bisbiguanide and considered as the gold standard for chemical plaque control.To be used twice daily for 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Willingness to comply with the study protocol.
2.Subjects who are diagnosed with Chronic generalized gingivitis.
3.Systemically healthy individuals.
4.Minimum of 10 gradable teeth. |
|
| ExclusionCriteria |
| Details |
1.Subjects suffering from any known systemic diseases.
2.Unable or not willing to comply with the study protocol.
3.Lactating and pregnant females.
4.Subjects who are smokers.
5.Subjects who have received any periodontal therapy in the last 6 months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction of clinical signs |
0 and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing effects of Acacia catechu mouthwash and Chlorhexidine on Gingivitis |
0 and 15th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/09/2020 |
| Date of Study Completion (India) |
18/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acacia catechu Willd (Khadir) belonging to Family-Fabaceae and subfamily-Mimosoideae is a historical plant which has a valuable importance because of its medicinal properties. Acacia catechu exhibits various pharmacological effects like anti-inflammatory, anti-diarrhoeal, hypoglycemic, antioxidant, hepatoprotective, antipyretic, antimicrobial, anticancer, antibacterial, anti-ulcer and antisecretory activities, sore throat and wound healing etc. Acacia catechu is also useful as a topical agent for sore gums and mouth ulcers. Thus the plant has diverse pharmacological actions. Acacia catechu extract may act as a good oral hygiene product because of its antimicrobial and anti-inflammatory activity. Since, there are no studies regarding the efficacy of Acacia catechu as a mouthwash, this study is carried out to assess the efficacy of Acacia catechu as mouthwash in treatment of gingivitis. |