| CTRI Number |
CTRI/2025/03/083416 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
herbs containing mouthwash in gingivitis patients |
|
Scientific Title of Study
|
Comparative evaluation of effect of herbal based mouthwash in gingivitis patient a randomized 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 |
Preshita Barai |
| Designation |
undergraduate student |
| Affiliation |
Ranjeet deshmukh dental college and research centre |
| Address |
Rnajeet Deshmukh Dental College,
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
|
| Fax |
|
| Email |
preshitabarai01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
surekha rathod |
| Designation |
professor |
| Affiliation |
Ranjeet Deshmukh Dental College, Nagpur |
| Address |
department of periodontology ,Ranjeet Deshmukh Dental College,
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
surekha rathod |
| Designation |
professor |
| Affiliation |
Ranjeet Deshmukh Dental College, Nagpur |
| Address |
department of periodontology ,
Ranjeet Deshmukh Dental College,
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
dept of periodontics
ranjeet deshmukh dental college and research centre |
| Type of Sponsor |
Research institution |
|
|
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 |
| Preshita Barai |
Ranjeet deshmukh dental college and research centre |
dept of periodontics, ranjeet deshmukh dental college and research centre, 440019
Nagpur
MAHARASHTRA |
9011071477
preshitabarai01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: scaling & root planning adjunct to mouthwash to be used twice a day after meal)
| | 2 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: scaling & root planning)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Minimum of 20 teeth should be present in the dentition, no visible signs of untreated caries.
2. Patient diagnosed with mild to moderate type of gingivitis.
3. Patient with bleeding on probing present, clinically.
4. Patient who had not received any periodontal therapy for the past 6 months.
5. Patient willing to give the informed consent and willing to comply with the study will be included
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering with any known systemic disease.
2. Patients having periodontitis
3. Patients having malocclusion
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gingival index, plaque index |
baseline , 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| papillary bleeding index |
baseline , 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
06/07/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Statement of problemThe peel of Citrus reticulata is widely used for various health benefits, including treating skin and stomach ailments, cancer, and as a diuretic, carminative, and immune-enhancing agent. It is also effective in preventing and treating vitamin deficiencies, colds, flu, scurvy, and combating bacterial and viral infections. Similarly, Jamun, also known as Syzygium cumini (family Myrtaceae), has significant medicinal value, particularly its seeds. While single-herbbased mouthwashes are available on the market, there is a lack of literature on polyherbal mouthwashes for the treatment of gingivitis. This paper proposes the effectiveness of a polyherbal mouthwash containing Syzygium cumini seed and orange peel for gingivitis patients. TreatmentNatural and herbal mouthwashes are becoming increasingly popular due to their numerous benefits over chemical agents. This rise in popularity can be attributed to their widespread availability, minimal or no side effects, moderate efficacy, and lower cost compared to chemical mouthwashes. The herbal extract proposed in this paper combines Syzygium cumini seed and orange peel. Orange, a tangy and juicy fruit from the Rutaceae family, is scientifically known as Citrus reticulata. Jamun, also called Syzygium cumini, belongs to the Myrtaceae family. Both fruits exhibit various beneficial effects, including antimicrobial, antioxidant, anticancer, and antitumor properties. Studies on the antimicrobial effects of herbal extracts have shown that they are effective against anaerobic periodontopathogens. Specifically, the minimal inhibitory concentration (MIC) of orange peel and Syzygium cumini seed extract was determined, demonstrating its effectiveness against three periodontopathogens: Aggregatibacter actinomycetemcomitans (Aa), Tannerella forsythia (Tf), and Porphyromonas gingivalis (Pg). Therefore, this extract can be effectively used in patients with chronic periodontitis. Sequential Procedure-  Diagnosis of the condition.  Detailed assessment of gingival status, including gingival index, plaque index, and bleeding on probing.  Sterilization of instruments.  Sequential arrangement of instruments.  Preparation with the operator’s gown and patient’s drape.  Perform scaling and root planing (non-surgical periodontal therapy, NSPT).  Prescribe and provide instructions for the use of mouthwash.  Demonstrate the correct brushing technique.  Re-evaluate the patient after 21 days, including: o Assessment of the patient’s oral hygiene status. o Re-evaluation of plaque and gingival indices. |