| CTRI Number |
CTRI/2025/03/082349 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of Neem-Tulasi Mouthwash and Chlorhexidine Mouthwash in Managing Plaque-Induced Gingival disease after Scaling |
|
Scientific Title of Study
|
Comparative Evaluation of Neem-Tulasi based mouthwash (BIOAYURVEDA) and Chlorhexidine mouthwash (HEXIDINE) after Scaling on Plaque Induced Gingivitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Priya |
| Designation |
POSTGRADUATE |
| Affiliation |
Army College of Dental Sciences |
| Address |
Room no 10, Department of Periodontics, PG clinic, ARMY COLLEGE OF DENTAL SCIENCES
JAI JAWAHAR NAGAR, CRPF ROAD,
CHENNAPUR,
SECUNDERABAD-500087
TELANGANA
Hyderabad
TELANGANA
500087
India |
| Phone |
9959964390 |
| Fax |
|
| Email |
saipriyaperio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sanjay Vasudevan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Army College of Dental Sciences |
| Address |
ROOM NO 10, Department of Periodontics, ARMY COLLEGE OF DENTAL SCIENCES
JAI JAWAHAR NAGAR, CRPF ROAD,
CHENNAPUR,
SECUNDERABAD-500087
TELANGANA
ROOM NO 10, Department of Periodontics, ARMY COLLEGE OF DENTAL SCIENCES
JAI JAWAHAR NAGAR, CRPF ROAD,
CHENNAPUR,
SECUNDERABAD-500087
TELANGANA
Hyderabad
TELANGANA
500087
India |
| Phone |
9849062087 |
| Fax |
|
| Email |
drsanjayvasudevan2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Priya |
| Designation |
POSTGRADUATE |
| Affiliation |
Army College of Dental Sciences |
| Address |
Room no 10, Department of Periodontics, PG clinic, ARMY COLLEGE OF DENTAL SCIENCES
JAI JAWAHAR NAGAR, CRPF ROAD,
CHENNAPUR,
SECUNDERABAD-500087
TELANGANA
Hyderabad
TELANGANA
500087
India |
| Phone |
9959964390 |
| Fax |
|
| Email |
saipriyaperio@gmail.com |
|
|
Source of Monetary or Material Support
|
| BIOAYURVEDA, B 2/66, NH-19, Block B, Mohan Cooperative Industrial Estate, New Delhi, India, 110044 |
| ICPA, 216-219, Adarsh Industrisl Estate, Sahar Road, Chakala, Andheri, Mumbai - 400099. |
|
|
Primary Sponsor
|
| Name |
Dr. Sai Priya |
| Address |
ARMY COLLEGE OF DENTAL SCIENCES
JAI JAWAHAR NAGAR, CRPF ROAD,
CHENNAPUR,
SECUNDERABAD-500087
TELANGANA
|
| Type of Sponsor |
Other [Army College of Dental Sciences] |
|
|
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 Sai Priya |
Army College of Dental sciences |
Room no 10, Department of Periodontics, PG clinic
Hyderabad
TELANGANA |
9959964390
saipriyaperio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACDS Institutional Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine mouthwash |
After oral prophylaxis patient is advised to use chlorhexidine mouthwash twice daily after 30 minutes of tooth brushing.
Patient is advised to mix 10 ml of chlorhexidine mouthwash with 10 ml of water and rinse it for 30 seconds |
| Intervention |
Neem+Tulasi mouthwash(Bioayurveda mouthwash) |
After oral prophylaxis patient is advised to use bioayruveda mouthwash twice daily after 30 minutes of tooth brushing.
Patient is advised to mix 10 ml of bioayruveda mouthwash with 10 ml of water and rinse it for 30 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with plaque induced gingivitis |
|
| ExclusionCriteria |
| Details |
Allergic to neem, turmeric
Patients with periodontitis
Prophylaxis done in past 6 months
Smoking, alcohol or tobacco consumption
Pregnant and lactating mothers
Subjects with orthodontic and prosthodontic appliances
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| recording reduction of gingival inflammation using gingival index, sulcular bleeding index |
0 and 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| recording plaque, debris and calculus score |
0 and 30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Informed consent is obtained from participating subjects. The subjects are assessed for plaque index, gingival index, oral hygiene index- modified, sulcus bleeding index. Following the recordings of clinical parameters, scaling was performed. Oral hygiene instructions along with the usage of designated mouthwash will be advised to respective groups. The patients will be instructed to follow the mouthwash usage as per the instruction and advised to rinse for 30 seconds twice a day after 30 minutes of tooth brushing. The clinical parameters were recorded again after 30 days. |