| 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 |
|
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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 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
|
|
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 |
|
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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. |