| CTRI Number |
CTRI/2025/05/086516 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Novel Herbal mouthrinse |
|
Scientific Title of Study
|
Antibacterial Potential of Ethanolic extract of Spilanthes acmella Mouthrinse Against Salivary Streptococcus mutans in Young Adults of Pondicherry- A Double-blinded Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shobana G |
| Designation |
Reader |
| Affiliation |
Sri Venkateshwaraa Dental college |
| Address |
Department of Public health dentistry,
13 A, Pondy Villupuram Main Road,
Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9843558822 |
| Fax |
|
| Email |
shobanask98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh |
| Designation |
Professor and Head |
| Affiliation |
Sri Venkateshwaraa Dental college |
| Address |
Department of Conservative Dentistry and Endodontics
13 A, Pondy Villupuram Main Road,
Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9443459210 |
| Fax |
|
| Email |
drdinesh.d.s@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGShobana |
| Designation |
Reader |
| Affiliation |
Sri Venkateshwaraa Dental college |
| Address |
Department of Public health dentistry, Dental department,
13 A, Pondy Villupuram Main Road,
Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9843558822 |
| Fax |
|
| Email |
shobanask98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Dental College, Puducherry- 605102, India |
|
|
Primary Sponsor
|
| Name |
GShobana |
| Address |
13A Pondy-villupuram Main road, Ariyur, Puducherry 605102, 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 |
| DrSDinesh |
Sri Venkateshwaraa Dental College |
Professor & Head of the Department, Department of Conservative dentistry and Endodontics, 13-A, Pondy villupuram road, Ariyur, Puducherry- 605 102
Pondicherry
PONDICHERRY |
9443459210
drdinesh.d.s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwaraa Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
atleast one active dental caries |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Spilanthes acmella, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Chlorhexidine mouthwash | Chlorhexidine mouthwash is gold standard antibacterial/antipalque agents. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
The subjects with atleast one active caries lesion.
2. The subjects with gingival and or/ periodontal disease
3. The subjects who brush only once daily.
4. the subject who signed informed consent to be recruited |
|
| ExclusionCriteria |
| Details |
Patients who received antibiotic therapy within past 3 weeks.
2. The subjects who had preventive dental procedures at last 48 hours.
3. The subjects those who had use mouth wash for past one month.
4. The subjects with limited manual dexterity and systemic illness.
5. Patients giving known history of allergy to any of the constituents of mouth rinses.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Salivary Streptococcus mutans Colony Count
• Measured using colony-forming units per milliliter (CFU/mL) in saliva samples.
• Saliva samples collected at:
o Baseline (Day 0)
o After 30 days of intervention (Final)
• The primary outcome evaluates the effectiveness of Ethanolic extract of Spilanthes acmella herbal mouthrinse in reducing bacterial load compared to control groups (Chlorhexidine).
|
Reduction in Salivary Streptococcus mutans Colony Count
• Measured using colony-forming units per milliliter (CFU/mL) in saliva samples.
• Saliva samples collected at:
o Baseline (Day 0)
o After 30 days of intervention (Final)
• The primary outcome evaluates the effectiveness of Ethanolic extract of Spilanthes acmella herbal mouthrinse in reducing bacterial load compared to control groups (Chlorhexidine).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Validated feedback questionnaire at the end of the intervention.
Evaluates participants’ perception of taste, aftertaste, & ease of use.
Adverse Effects or Oral Discomfort are monitored during the study.
|
At the end of 30 days, feedback to be collected from the participants |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="30" |
|
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
|
Dental caries is a multifactorial infectious disease and ubiquitous in all population throughout the world. The most alarming is a greatest concern from public health point of view. Oral cavity contains wider variety of bacteria, streptococcus mutans and lactobacilli , in that streptococcus mutans are the responsible for the cause of initiation of dental caries. Reduction of streptococcus mutans load in the oral cavity by using antibacterial agent. Herbal is the safe and effective for clinical implication. |