| CTRI Number |
CTRI/2023/09/057522 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
02/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study effect of topical application of Argyreia Speciosa gel and Triphala gel as an adjunct to scaling in gingivitis patients. |
|
Scientific Title of Study
|
Comparative evaluation of topical application of Argyreia Speciosa gel and
Triphala gel as an adjunct to scaling in treatment of gingivitis: A clinical
study |
| Trial Acronym |
CATS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kedar Kulkarni |
| Designation |
PG Student |
| Affiliation |
SMBT Dental College and Hospital,Sangamner |
| Address |
G-02 Department of periodontology and oral implantology, SMBT Dental College and Hospital
Amrutnagar Ghulewadi Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9422024315 |
| Fax |
|
| Email |
kedarkulkarni301@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Patil |
| Designation |
Reader and PG Guide |
| Affiliation |
SMBT Dental College and Hospital,Sangamner |
| Address |
G-02 Department of periodontology and oral implantology, SMBT Dental College and Hospital
Amrutnagar Ghulewadi Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9325596570 |
| Fax |
|
| Email |
dr.saurabh.subhash.patil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kedar Kulkarni |
| Designation |
PG Student |
| Affiliation |
SMBT Dental College and Hospital,Sangamner |
| Address |
G-02 Department of periodontology and oral implantology, SMBT Dental College and Hospital Amrutnagar Ghulewadi Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9422024315 |
| Fax |
|
| Email |
kedarkulkarni301@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital Sangamner Maharashtra 422608 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
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 Kedar Kulkarni |
SMBT Dental College & Hospital |
G-02 Department of Periodontology and Oral Implantology, Sangamner
Ahmadnagar
MAHARASHTRA |
09422024315
kedarkulkarni301@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee on Ethics,SMBT Dental College,Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K051||Chronic gingivitis. Ayurveda Condition: DANTAVESHTAKAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Scaling Alone |
Only Scaling will be done and patient recall after 15 days |
| Intervention |
Topical Application of Argyreia Speciosa Gel as an adjunct to scaling |
After scaling patients will be asked to apply topical application of Argyreia Speciosa Gel 3 times a day for 15 days
1)Medicine Name: Argyreia Speciosa Gel,Route: Topical,Dosage Form: Dantamanjan Churna/Gum Paint,Dose: 2(drops), Frequency: tds,Duration: 15 Days |
| Intervention |
Topical Application of Triphala Gel as an adjunct to scaling |
After scaling patients will be asked to apply topical application of Triphala Gel 3 times a day for 15 days
1)Medicine Name: Triphala Gel,Route: Topical,Dosage Form: Dantamanjan Churna/Gum Paint,Dose: 2(drops), Frequency: tds,Duration: 15 Days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Chronic gingivitis patients with a minimum of 16 gradable teeth.
2) Systemically healthy patients.
3) Patients requiring scaling.
4) Both males and females between the age group of 20-60 year with ≤ 3 mm of probing depth
(PD).
5) Patient not on systemic antibiotics for the past 3 months.
6) No use of anti-inflammatory drugs within the past 3 months
7) Availability of the patient for the entire duration of the study.
8) Not receiving periodontal treatment within last 6 months.
9) Patient should be able to understand and give a written informed consent |
|
| ExclusionCriteria |
| Details |
1) Patients with history of deleterious habits (i.e., use of tobacco consumption etc.)
2) Patients with systemic diseases (i.e., diabetes mellitus, cancer, HIV, bone metabolic
diseases).
3) Patients on systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or
chemotherapy prescribed or received within 2 months prior to study entry.
4) Pregnant and/or lactating females.
5) Patients contraindicated for scaling |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in gingival inflammation and plaque formation |
Baseline to 15 Days |
|
|
Secondary Outcome
|
|
|
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 4 |
|
Date of First Enrollment (India)
|
22/01/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kedarkulkarni301@gmail.com].
- For how long will this data be available start date provided 22-01-2025 and end date provided 22-03-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aim of the study is to compare the effect of topical application of Argyreia Speciosa gel and Triphala Gel as an adjunct to scaling with scaling alone in terms of reduction in dental plaque, gingival inflammation along with gingival bleeding in gingivitis. All the participants will be explained about the need, design of study. Informed written consent will be obtained from the patients. Clinical case history will be recorded. All the clinical parameters (GI, SBI, PI) will be recorded at baseline using UNC 15 periodontal probe (Hu Friedy). Each patient will undergo ultrasonic scaling (EMS) by a single operator. It is a single blind study in which the patient will be randomly assigned to either topical application of Argyreia Speciosa gel orTriphala Gel as an adjunct to scaling or scaling alone using “Computer generated†method. After full-mouth scaling, subjects from test group will be instructed to take a pea size portion of the Argyreia speciosa gel or Triphala Gel on the index finger and gently massage all over the gingiva, twice a day after brushing for 15 days as directed by the manufacturer. Patients will be instructed to follow the standard advised oral hygiene measures. The subjects who missed the application of gel will be excluded from the study. The subjects will be re-evaluated for the GI, SBI and PI after 15 days. All the clinical parameters will be recorded at baseline and after 15 days by second blinded operator. |