| CTRI Number |
CTRI/2022/12/048007 [Registered on: 12/12/2022] Trial Registered Prospectively |
| Last Modified On: |
25/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Guava Leaf Mouthwash in treatment of gum inflammation among 18-35-year-old adults |
|
Scientific Title of Study
|
Efficacy of mouthwash containing Guava Leaves Extract as an Adjunct to Therapy for Plaque-Induced Gingivitis – 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 |
Praveena S |
| Designation |
Postgraduate Trainee |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
1, Alapakkam main road, Meenakshi Ammal Dental College and Hospital, Maduravoyal, Chennai- 95
Meenakshi Ammal Dental College and Hospital, Maduravoyal, Chennai 95
Chennai
TAMIL NADU
600095
India |
| Phone |
9626784014 |
| Fax |
|
| Email |
praveenasubramanian17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preetha Elizabeth Chaly |
| Designation |
Professor and HOD |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
1, Alapakkam main road, Meenakshi Ammal Dental College and Hospital, Maduravoyal, Chennai 95
Meenakshi Ammal Dental College and Hospital, Maduravoyal, Chennai 95
Chennai
TAMIL NADU
600095
India |
| Phone |
9626784014 |
| Fax |
|
| Email |
drpchay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preetha Elizabeth Chaly |
| Designation |
Professor and HOD |
| Affiliation |
Meenakshi Ammal Dental College and Hospital, Chennai 95 |
| Address |
1, Alapakkam main road, Meenakshi Ammal Dental College and Hospital, Chennai 95
Meenakshi Ammal Dental College and Hospital, Maduravoyal, Chennai 95
Chennai
TAMIL NADU
600095
India |
| Phone |
9626784014 |
| Fax |
|
| Email |
drpchay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenaskhi Ammal Dental College and Hospital, Chennai. |
| Praveena s |
|
|
Primary Sponsor
|
| Name |
Praveena s |
| Address |
1 Alapakkam main road, Meenakshi Ammal Dental College and Hospital,Chennai 95 |
| Type of Sponsor |
Other [Other] |
|
|
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 Preetha Elizabeth Chaly |
Meenakshi Ammal Dental College and Hospital |
Room no:4, Department of Public Health Dentistry,
1, Alapakkam Main Road, Maduravoyal, Chennai 95
Chennai
TAMIL NADU |
9840330834
drpchaly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Meenakshi Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guava mouthwash, Reference: -, Route: Oral, Dosage Form: Dravaka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 15 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | chlorhexidine 0.2% | 0.2% chlorhexidine mouthwash. Route: Oral Dosage: 10 ml, Frequency: twice daily, Duration: 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patient with moderate to severe gingivitis
Patient willing to participate in study with informed consent |
|
| ExclusionCriteria |
| Details |
1.Subjects with systemic illness which affects the gingival health
2.Subjects who are under medications which affects gingival health
3.Subjects undergoing orthodontic treatment
4. Subjects who were under antibiotic coverage in the last three months
5.Tobacco users
6. People using any other mouthwash or have history of hypersensitivity to mouthwash.
7. Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Gingival inflammation |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of Gingival bleeding |
6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
14/12/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Sure for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study involves the examination of Gingival bleeding and Inflammation assessment, following the Guava leave extraction mouthwash. The study recruitment is not yet started. The publication of the study will be decided at the end of the study trial. |