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CTRI Number  CTRI/2023/05/052310 [Registered on: 04/05/2023] Trial Registered Prospectively
Last Modified On: 02/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study effect of topical application of Argyreia Speciosa gel as an adjunct to scaling in gingivitis patients 
Scientific Title of Study   Comparative evaluation of anti-plaque and anti-inflammatory effect of topical application of Argyreia Speciosa gel as an adjunct to scaling: A clinical study 
Trial Acronym  CASAS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishali Kisan Lihe 
Designation  Post graduate student 
Affiliation  SMBT Dental College and Hospital Sangamner 
Address  G-02 Department of periodontology and oral implantology, SMBT Dental College and Hospital Sangamner

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9518926055  
Fax    
Email  lihevaishali29@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 Sangamner

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9325596570  
Fax    
Email  dr.saurabh.subhash.patil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaishali Kisan Lihe 
Designation  Post graduate student 
Affiliation  SMBT Dental College and Hospital Sangamner 
Address  G-02 Department of periodontology and oral implantology, SMBT Dental College and Hospital Sangamner

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9518926055  
Fax    
Email  lihevaishali29@gmail.com  
 
Source of Monetary or Material Support  
SMBT dental collage and hospital, Sangamner, Maharashtra 422608 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [none] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishali Lihe  SMBT dental college and hospital  G-02 Department of periodontology and oral implantology, Sangamner
Ahmadnagar
MAHARASHTRA 		 9518926055

lihevaishali29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Committee on Ethics, SMBT Dental collage, Sangamner  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Argyreia speciosa gel as an adjunct to scaling   Chronic gingivitis patient requiring scaling will be selected. After scaling patient will be ask to apply topical application of gel (2 drops) thrice daily for 15 days. After 15 days patient will be recall. 
Comparator Agent  Scaling alone  Chronic gingivitis patient requiring scaling will be selected. Only scaling will be done. Patient recall after 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 years with 3mm of probing depth
5)Patient not on systemic antibiotics for the past 3 months
6)No use of anti-inflammatory drug 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 inform 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  
Outcome  TimePoints 
-  - 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/05/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [lihevaishali29@gmail.com].

  6. For how long will this data be available start date provided 15-03-2024 and end date provided 15-05-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Aim of the study is to compare the effect of topical application of Argyreia Speciosa 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 were explained about the need, design of study. Informed written consent was obtained from the patients. Clinical case history was recorded. All the clinical parameters (GI, SBI, PI) were recorded at baseline using UNC 15 periodontal probe (Hu Friedy). Each patient were undergo ultrasonic scaling (EMS) by a single operator. It is a single blind study in which the patient was randomly assigned to either topical application of Argyreia Speciosa gel as an adjunct to scaling or scaling alone using “Computer generated” method. After full-mouth scaling, subjects from test group were instructed to take a pea size portion of the Argyreia speciosa 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 was instructed to follow the standard advised oral hygiene measures. The subjects who missed the application of gel was excluded from the study. The subjects was  re-evaluated for the GI, SBI and PI after 15 days. All the clinical parameters were recorded at baseline and after 15 days by second blinded operator. 
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