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CTRI Number  CTRI/2020/08/027305 [Registered on: 21/08/2020] Trial Registered Prospectively
Last Modified On: 21/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparative evaluation of the effectiveness of Stevia extract used as powder versus Amoxicillin trihydrate powder(antibiotic) in surgical extraction of lower wisdom tooth among 18-45-year-old adults - A split mouth Randomized controlled trial.” 
Scientific Title of Study   Comparative evaluation of the effectiveness of Stevia extract used as powder versus Amoxicillin trihydrate powder in surgical extraction of mandibular third molar among 18-45-year-old adults - A split mouth 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  Dr Nidhi Pandey 
Designation  Postgraduate Student 
Affiliation  YMT Dental College and Hospital 
Address  Department of OMFS, YMT Dental college and hospital, plot no. 18, sector 4, Kharghar, Navi Mumbai

Mumbai
MAHARASHTRA
410210
India 
Phone  8424042203  
Fax    
Email  nidhi.pandey2807@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rinku Kalra 
Designation  Reader and Guide 
Affiliation  YMT Dental College and Hospital 
Address  Department of OMFS, YMT Dental college and hospital, plot no. 18, sector 4, Kharghar, Navi Mumbai

Mumbai
MAHARASHTRA
410210
India 
Phone  9167391340  
Fax    
Email  drrinkukalra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Pandey 
Designation  Postgraduate Student 
Affiliation  YMT Dental College and Hospital 
Address  Department of OMFS, YMT Dental college and hospital, plot no. 18, sector 4, Kharghar, Navi Mumbai

Mumbai
MAHARASHTRA
410210
India 
Phone  8424042203  
Fax    
Email  nidhi.pandey2807@gmail.com  
 
Source of Monetary or Material Support  
Department of OMFS, YMT Dental College and Hospital, Plot no. 18, sector-4, Kharghar, Navi Mumbai-410210 
 
Primary Sponsor  
Name  Dr Nidhi Pandey 
Address  Department of OMFS, YMT Dental college and Hospital, plot no. 18, sector-4, kharghar, Navi Mumbai- 410210 
Type of Sponsor  Other [self] 
 
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 Nidhi Pandey  YMT Dental College and Hospital  YMT Dental college and Hospital, plot no 18, sector -4, Kharghar, Navi Mumbai-410210
Mumbai
MAHARASHTRA 		 8424042203

nidhi.pandey2807@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee, YMT Dental College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  impacted mandibular third molars requiring surgical extraction under local anesthesia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Amoxicillin trihydrate powder  Topical administration of Amoxicillin trihydrate powder (500mg) will be done (only once) followed by placement of abgel in the postextraction socket and the wound will be closed with water tight sutures. assessment of antimicrobial action at the extraction site on day 1, day 3 and day 7 postoperatively will be carried out. 
Intervention  Stevia extract  Topical administration of Stevia extract (180mg) will be done (only once) which will be followed by placement of abgel in the postextraction socket and the wound will be closed with water tight sutures. Assessment of antimicrobial action at the extraction site on day 1, day 3 and day 7 postoperatively will be carried out. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients aged between 18-45 years
2. Patients of both sexes will be included.
3. Patients with good physical and mental status.
4. Patient requiring bilateral surgical extraction of mandibular third molars.
5. Absence of any infection (pericoronitis) prior to the surgery.
6. Patients with non-palpable submandibular lymph nodes.
7. Patients who were not on antibiotics for last 7 days.
8. Patients consenting for the study 
 
ExclusionCriteria 
Details  1 Patients with a known medical history
2 Febrile patients with an active infection elsewhere
3 Patients with an immune-compromised state.
4 Patients with a known drug and /or food allergy
5 A recent use of antimicrobial drug (in the last 7 days).
6 Uncooperative patients, mentally retarded patients.
7 Pregnant or lactating mothers. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
FACIAL MEASUREMENTS
HORIZONTAL
VERTICAL
AXILLARY TEMPERATURE
WBC COUNT
LYMPH NODES
MOUTH OPENING
PAIN
SUPPURATION
Wound dehiscence
Erythema of the surrounding intraoral tissues
 		 outcomes measured at day 1 day 3 and day 7 postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
postoperative antimicrobial activity  outcomes measured at day 1 day 3 and day 7 postoperatively 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   24/08/2020 
Date of Study Completion (India) 21/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This is a split mouth randomized controlled trial to compare and evaluate the antimicrobial activity of stevia extract powder and amoxicillin trihydrate powder after surgical extraction of mandibular third molar extraction in an adult population 18 to 45 years group. The sample size was calculated as 40 patients. the sample size will be divided randomly into 2 groups consisting of 40 patients in each group using computer generated random numbers. Informed consent will be taken from the patient. The study group will consist of patients recieving stevia extract powder topically in the extraction socket followed by placement of abgel and suturing of the wound. the control group will consist of patients where administration of amoxicillin trihydrate powder topically in the extraction socket followed by abgel placement and suturing will be done. The postoperative outcomes to be assessed  are presence or absence of erythema, suppuration, pain, edema, Wound dehiscence, WBC counts, mouth opening and facial measurements. These outcomes will be recorder in a proforma for each patient. 
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