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CTRI Number  CTRI/2018/04/013494 [Registered on: 26/04/2018] Trial Registered Retrospectively
Last Modified On: 23/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Painless Tooth Extraction Jalandhar Bandha : A clinical study 
Scientific Title of Study   A Clinical Study On The Evaluation Of Anaesthetic Effect Of Jalandhar Bandha In Danta Nirharana Kriya (Tooth Extraction) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashutosh Dwivedi 
Designation  M.D. Scholar , Department of Swasthavritta and Yoga 
Affiliation  National Institute Of Ayurveda Jaipur 
Address  Dept. Of Swathavritta and Yoga ,National Institute Of Ayurveda, near Jorawar Singh Gate Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9424096001  
Fax    
Email  drashutosh1984@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  VAIDYA KAMALESH KUMAR SHARMA 
Designation  Professor & H.O.D. Department of Swasthavritta and Yoga 
Affiliation  National Institute Of Ayurveda Jaipur 
Address  Dept. Of Swathavritta and Yoga,National Institute Of Ayurveda, near Jorawar Singh Gate Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9413345633  
Fax    
Email  kksayu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kashinath Samagandi 
Designation  Assistant Professor, Department of Swasthavritta and Yoga 
Affiliation  National Institute Of Ayurveda Jaipur 
Address  Dept. Of Swathavritta and Yoga ,National Institute Of Ayurveda, near Jorawar Singh Gate Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  7877444353  
Fax    
Email  kashisri@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda Jaipur 
 
Primary Sponsor  
Name  National Institute Of Ayurveda 
Address  Near Jorawar Singh Gate, Amer Road Jaipur-302002 
Type of Sponsor  Government medical college 
 
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 Ashutosh Dwivedi  National Institute Of Ayurveda  Room no 12,Danta chikitsa Kaksha Arogya shala ,Madhav vilas Near Jorawar Singh Gate,Amer Road Jaipur
Jaipur
RAJASTHAN 
9424096001

drashutosh1984@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute Of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (3) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, mobile tooth of 1-3 grades.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Extraction of mobile tooth by anesthetising solution injected, and adopting extraction of tooth according to modern method. Wound management: Modern methodology   Extraction of mobile tooth by anesthetising solution(Lignocaine with Adrenalin) injected, and adopting extraction of tooth according to modern method. Wound management: Modern methodology is used to manage the wound.  
Intervention  Extraction of mobile tooth by Jalandhar Bandha technique. Wound management: Ayurvedic methodology  Extraction of mobile tooth by anesthetising the mandible and maxilla by adopting Jalandhar Bandha technique and extraction of tooth according to traditional method. Wound management: Ayurvedic methodology is used to manage the wound with Rakta Stambhaka yoga (Gairika , Triphala, sphatika Bhasma ,Lodhra and Maju phala) followed by dressing with Triphala ,Kasis and Sphatika bhasma  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age between 20 to 70 years.
2. Irrespective of gender, religion and occupations.
3. Samples showing the mobile tooth of 1-3 grades.
4. Diabetic and Hypertensive patients having control in blood sugar level and normal blood pressure respectively. 
 
ExclusionCriteria 
Details  1. Age below 20 years and more than 70 years.
2. Ardita (Facial paralysis), Sandhi shoola , cervical spondilosis ,orthopaedic problems etc which disable to sit in Sukhasana / Padmasana  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Jalandhar Bandha technique may help in inducing the anaesthetic effect and it may help to extract the tooth without pain with minimum gingival bleeding  20 days after first patient registration 
 
Secondary Outcome  
Outcome  TimePoints 
Wound healing and Raktastambhaka(Anti-coagulant) property of Ayurveda Drugs.  30 days after first patient registration 
 
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 1/ Phase 2 
Date of First Enrollment (India)   21/02/2018 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Chala danta (mobile tooth) and Krimi dantha (caries tooth) are commonest disease which affect every individual one or the other day.  Chala Danta, is one of the most common ailments of senile period. Due to looseness of the tooth socket, the tooth becomes mobile. Krimi dantha is also one of the ailments which is caused due to poor oral hygiene. Children and youth are the major sufferer of this condition. Root canal treatment or extraction will be the method of management. Root canal treatment is advised if caries is mild to moderate to save the tooth. It includes anesthesia, drilling, root cap installation, repeated hospital visit etc. If the caries is severe, then extraction is ultimate.  Severe caries tooth and mobile tooth impart difficulties in the process of food consumption concerned to biting, mastication, deglutition & irritation and severe pain which is an indication for tooth extraction. Extraction will be the right choice instead of preserving it. Extraction is an easy method, but people are scared of techniques used for extractions. Usual process of extraction includes anesthetising the gum socket, then widening of the socket followed by extraction. Along with this there are other factors which makes a person unsuitable for the process of extraction, like phobia for pricks, allergy to anesthetising agents, some of the anesthetising agent worsen the condition of hypertension,  if patient is diabetic, his blood sugar must be normal before extraction or otherwise contraindicated for extraction, if the person is on any anticoagulants then there will be delayed blood clotting, if multiple mobile tooth are present , then for every extraction same process will be repeated. These factors pose a great impact on tooth extraction and antibiotic course further causes unnecessary side effects after each extraction.

             Some of the techniques mentioned in Yoga and Ayurveda, can be applied for extraction of the mobile tooth or caries tooth without much complications. Some of the traditional and conventional practitioners of Gujrat, Madhya Pradesh, Maharashtra and Karnataka adopt the technique of Jalandhar Bandha for anesthetise and minimize the bleeding, followed by herbal drugs for the purpose of wound healing.

             Present study is planned to give scientific base for the Jalandhar Bandha technique and herbal drugs for painless tooth extraction without any invasive techniques.

 

 
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