| CTRI Number |
CTRI/2026/02/103925 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
14/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Conventional Technique of Pain Less Tooth Extraction with Jalandhara Bandha |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL STUDY ON THE ANALGESIC AND HEMODYNAMIC EFFECTS OF JALANDHARA BANDHA DURING DANTOTPATANA |
| 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 Pouse Poulose |
| Designation |
Associate Professor |
| Affiliation |
Netra Chikitsa Ayurved College, Amreli |
| Address |
Ph D Scholar Glocal University Saharanpur Uttar Pradesh Associate Professor Netra Chikitsa Ayurved College Chittal Road Amreli Gujarat 365601 Mirzapur UTTAR PRADESH 247121 India |
| Phone |
9446494897 |
| Fax |
|
| Email |
pousepoulose@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Thomas T |
| Designation |
Professor |
| Affiliation |
Glocal University |
| Address |
Idupadickal
Oyur
Kollam
Kerala Professor and HOD
Department of Shalya Tantra
Kollam KERALA 691510 India |
| Phone |
9447461490 |
| Fax |
|
| Email |
drthomas55@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Thomas T |
| Designation |
Professor |
| Affiliation |
Glocal University |
| Address |
Idupadickal
Oyur
Kollam
Kerala Professor and HOD
Department of Shalya Tantra
Kollam KERALA 691510 India |
| Phone |
9447461490 |
| Fax |
|
| Email |
drthomas55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil, Netra Chikitsa Ayurved College Amreli Gujarat |
|
|
Primary Sponsor
|
| Name |
Pouse Paulose |
| Address |
Associate Professor Dept of Shalya Tantra Netra Chikitsa Ayurved College Amreli Gujarat |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Thomas T |
Glocal University |
MIRZAPUR SAHARANPUR Mirzapur UTTAR PRADESH |
94474 61490
drthomas55@gmail.com |
| Dr Asokan V |
Netra Chikitsa Ayurved College Hospital |
NCT Campus Chittal Road Amreli GUJARAT |
6361740431
drasokan24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K084||Partial loss of teeth. Ayurveda Condition: DANTACALAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Dantotpatana | (Procedure Reference: Ayurveda and Hatha Yoga Literature , Procedure details: Pre-extraction Patient will be thoroughly examined & a decision is made for conservative management or tooth extraction Pre-extraction counselling & training in Jalandhara Bandha for the experimental group will be done If the patients are krisha(lean) durbala (debilitated) or vriddha(aged) sukumara (delicate) special care to be taken The patient should gargle the mouth with luke warm saline water to clean out excess saliva for better grip
Pradhana Karma Patient will be made to sit in sukhasana or siddhasana vajrasana padmasana on a wooden plank of 2 to 3 inch height Patient should be calm, relaxed & focus on throat vishuddhi cakra & hold the knee joints with both hands While doing this inhale a slow & deep breath making elbows straight & raising the shoulders Dental surgeon (researcher) standing behind the patient put a clean cloth on the head of the patient & moving slowly forward & back ward bend the neck towards the chest so that the chin gets locked on sternal or jugular notch
Surgeon then puts pressure on the spine using his or her left knee joint & puts pressure on the trigeminal nerve using left hand Then the patients neck is moved up & down 2 to 3 times & then head is lifted up & tooth is extracted by using appropriate tooth extraction forceps
Control group will receive standard extraction without yoga intervention
Local anaesthesia will not be administered in the intervention group unless requested mid-procedure Rescue intervention
Monitoring of physiological parameters before during & after the procedure
Post Intervention Procedure After teeth extraction check for complete extraction of the desired teeth & look out for any bleeding Standard care after tooth extraction will be adopted in both groups The Jalandhara Bandha will be released after the tooth extraction Appropriate rest care & follow up is advised)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Standard Tooth Extraction | Patients undergoing extraction without Jalandhara Bandha and with standard contemporary tooth extraction |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Individual of either gender aged between 18 to 75 years
Mobile teeth requiring extraction indicated for non-surgical tooth extraction
Willingness to participate and provide informed written consent
No history of systemic disease that would interfere with yoga or dental procedure
|
|
| ExclusionCriteria |
| Details |
History of cervical spine disease or vertigo
Cardiac or respiratory problems that contraindicate breath-holding
Mental health issues that may impair pain perception reporting
Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS SCORE TO ASSESS PAIN AFTER TOOTH EXTRACTION BY JALANDHARA BANDHA
Vitals stable
Without any bleeding or discomfort |
BASE LINE AT THE END OF 7 DAYS 14 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Not feeling of associated complaints of giddiness or neck discomfort
Selfarrest of bleeding & remission of pain if any |
BASE LINE AT THE END OF 7 DAYS 14 DAYS |
|
|
Target Sample Size
|
Total Sample Size="172" Sample Size from India="172"
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 1 |
|
Date of First Enrollment (India)
|
05/03/2026 |
| 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="2" Months="0" 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
|
Introduction Tooth extraction is one of the most common minor surgical procedures associated with pain and anxiety Traditional yogic practices like jalandhara bandha known for their influence on the autonomic nervous system and pain perception offer a promising non-pharmacological alternative to pain relief Dantotpatana tooth extraction is a traditional ayurveda surgical procedure often associated with discomfort and pain The search for non invasive drug free methods of pain control has led to the exploration of yogic practices such as jalandhara bandha throat lock which may modulate autonomic responses and pain perception This study proposes a novel randomized controlled trial for evaluating the efficacy of Jalandhara Bandha as a supportive technique in achieving painless tooth extraction as a viable holistic alternative in dental care to bridge traditional Ayurvedic wisdom with modern dentistry Dental pain is a leading cause of patient anxiety in clinical settings Conventional pain management typically involves local anesthesia which may cause side effects and is contraindicated in certain individuals Jalandhara bandha one of the three classical bandhas in hatha yoga has shown influence over pain modulation by increasing parasympathetic activity and reducing sympathetic tone Jala means network of nerves arteries and veins So locking or blocking of this nerve plexus around neck for painless tooth extraction without use of local anesthesia Advantages of this technique No Allergic Reactions Many patients are allergic to local anesthesia or other medications This integrated approach eliminates the need for any drugs Safe for Diabetics People with high blood sugar often experience side effects from even minor surgeries This method is safer for such patients as it has no adverse effects Faster Healing The procedure promotes faster healing of the gums and does not harm healthy tissues, unlike conventional methods Primary Objective To evaluate the efficacy of jalandhara bandha on hemodynamic parameters in reducing or eliminating the pain perception during dantotpatana non surgical tooth extraction Secondary Objectives To compare VAS pain scores between patients undergoing extraction with and without jalandhara bandha To assess patient satisfaction and psychological comfort using Likert Scale To explore the feasibility of integrating jalandhara bandha yogic practice in minor oral surgical procedures Limitations Subjectivity of Pain Pain perception varies between individuals Training Requirement: Not all patients may be able to perform jalandhara bandha Null Hypothesis The application of Jalandhara bandha has no significant effect on hemodynamic factors and in the reduction or elimination of pain perception during dantotpatana nonsurgical tooth extraction Alternate Hypothesis Jalandhara Bandha has a significant effect on hemodynamic factors and reduces or eliminates pain perception during dantotpatana non-surgical tooth extraction |