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CTRI Number  CTRI/2024/05/067196 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 08/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry
Other (Specify) [Anti-hypersensitivity efficacy of toothpaste]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Bilwa or bael and Spinach based toothpaste in the reducing tooth sensitivity. 
Scientific Title of Study   Comparative evaluation of Desensitizing effect of Aegle marmelos toothpaste, Spinacia oleracea toothpaste and their combination with commercially available desensitizing toothpaste: A Double-blinded Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yuvarani K P 
Designation  Postgraduate student 
Affiliation  KAHER’s KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department number 2, Public Health Dentistry, Ground floor, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  07639270619  
Fax    
Email  yuvasrikpyk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yuvarani K P 
Designation  Postgraduate student 
Affiliation  KAHER’s KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department number 2, Public Health Dentistry, Ground floor, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi


KARNATAKA
590010
India 
Phone  07639270619  
Fax    
Email  yuvasrikpyk@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrRoopali M Sankeshwari 
Designation  Professor 
Affiliation  KAHER’s KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department number 2, Public Health Dentistry, Ground floor, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9844837197  
Fax    
Email  drroopali@kledental-bgm.edu.in  
 
Source of Monetary or Material Support  
Department of Public Health Dentistry, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi-590010, Karnataka, India 
 
Primary Sponsor  
Name  Dr Yuvarani K P 
Address  Department number 2, Public Health Dentistry, Ground floor, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi 590010, Karnataka, India 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
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 Yuvarani K P  KAHER’s KLE Vishwanath Katti Institute of Dental Sciences  Department no:2, Public Health dentistry, Ground floor, JNMC campus, Nehru Nagar, Belagavi 590010, Karnataka, India Belgaum KARNATAKA
Belgaum
KARNATAKA 		 07639270619

yuvasrikpyk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aegle marmelos toothpaste,Spinacia oleracea toothpaste and their combination  To be used as a toothpaste for brushing twice daily, morning and night, 2 minutes for a period of 4 weeks in adults with dentin hypersensitivity. 
Comparator Agent  Sensodyne active repair toothpaste  To be used as a toothpaste for brushing twice daily, morning and night, 2 minutes for a period of 4 weeks in adults with dentin hypersensitivity. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1)Patients in the age group of 20–50 years
2)Patients with a minimum of two hypersensitive teeth which are anterior to molars and demonstrated signs of facial/cervical erosion, abrasion, and/or gingival recession.
3)The study teeth must be caries-free and with no restorations;
4)Patients who haven’t used any desensitizing toothpaste within the last 3 months
5)Patients with either no clinical mobility or grade I mobility will be included.
6)Patients who are willing to be available during the duration of the study and to sign an informed consent form.
 
 
ExclusionCriteria 
Details  1)Patients with gross underlying pathologies.
2)Subjects with any other systemic/psychological conditions.
3)Pregnant and lactating females will be excluded
4)Development alterations like hypoplasia or fluorosis.
5)Use of orthodontic device or appliance
6)Subjects with any history of allergy reactions to herbal medicaments or toothpaste
7)Subjects suffering from a chronic medical disease or conditions which are associated with intermittent episodes or constant daily pain
8)Subjects who are taking certain medications (anti-inflammatory drugs or antibiotics) daily during the previous 7 days;
9)Subjects who are unwilling to complete the treatment protocol.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of dentin hypersensitivity using tactile stimulus and thermal stimulus test which includes air-blast, cold, and application of an acidic solution   2nd week and 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
Visual analog scale and schiff score  2nd week and 4th week 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/05/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The gold standard treatment modality for dentin hypersensitivity has not yet been established. There are two strategies to control the hydrodynamic mechanism of pain for managing DH. Agents that reduce fluid flow within the dentine tubules by occluding the tubules, thereby blocking the stimuli, and those that interrupt the neural response to the stimuli. Oxalates reduce dentinal hypersensitivity by occluding the dentinal tubules and Potassium reduces dentinal hypersensitivity by either occluding the dentinal tubules or desensitization of nerve fibers/blocking the neural transmission. Since Aegle marmelos and Spinacea oleracea contain more potassium with phenols and oxalates respectively, this study emphasizes the herbal desensitizing toothpaste containing Aegle marmelos (Bilwa/Bael) and Spinacea oleracea (Spinach) to reduce the dentin hypersensitivity in the age group of 20-50 years through tactile, thermal test using visual analog scale and schiffs score with the followup evaluation at 2nd and 4th week. 
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