FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077448 [Registered on: 28/11/2024] Trial Registered Prospectively
Last Modified On: 16/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   The effect of Ultrasound Therapy on post-operative pain in root canal treated tooth 
Scientific Title of Study   The effect of Low Intensity Pulsed Ultrasound Therapy on post-operative pain in endodontically treated tooth - A Randomized Clinical 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 Deepika H S 
Designation  Post Graduate Student  
Affiliation  Srinivas Institute of Dental Sciences 
Address  Room no. 3, Department of Conservative Dentistry and Endodontics, Srinivas Institute of Dental Sciences, Srinivas Nagar, Mukka, Surathkal, Mangalore, Karnataka

Dakshina Kannada
KARNATAKA
574146
India 
Phone  9448929519  
Fax    
Email  hsdeepikashankar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kishan K V 
Designation  Professor and Head  
Affiliation  Srinivas Institute of Dental Sciences 
Address  Room no. 3, Department of Conservative Dentistry and Endodontics, Srinivas Institute of Dental Sciences, Srinivas Nagar, Mukka, Surathkal, Mangalore, Karnataka

Dakshina Kannada
KARNATAKA
574146
India 
Phone  8141787335  
Fax    
Email  drkishankv@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Kishan K V 
Designation  Professor and Head  
Affiliation  Srinivas Institute of Dental Sciences 
Address  Room no. 3, Department of Conservative Dentistry and Endodontics, Srinivas Institute of Dental Sciences, Srinivas Nagar, Mukka, Surathkal, Mangalore, Karnataka

Dakshina Kannada
KARNATAKA
574146
India 
Phone  8141787335  
Fax    
Email  drkishankv@yahoo.co.in  
 
Source of Monetary or Material Support  
Srinivas Institute of Dental Sciences, Mukka, Surathkal, Mangalore, Karnataka 574146 
 
Primary Sponsor  
Name  Dr Deepika H S 
Address  Room no. 3, Department of Conservative Dentistry and Endodontics, Srinivas Institute of Dental Sciences, Srinivas Nagar, Mukka, Surathkal, Mangalore, Karnataka 
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 Deepika H S  Srinivas Institute of Dental Sciences   Room no. 3, Department of Conservative Dentistry and Endodontics, Srinivas Institute of Dental Sciences, Srinivas Nagar, Mukka, Surathkal, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA 		 9448929519

hsdeepikashankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Srinivas Institute of Dental Sciences Ethical Committee (SIDSEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low intensity pulsed ultrasound therapy  The system consists of two different handpieces for extra oral and intra oral therapy, a unit which displays time, various modes of ultrasound, intensity, frequency. The therapy will be given on 1st, 3rd and 5th day and the study will be completed in 4 to 6 months  
Comparator Agent  Placebo  Without low intensity pulsed ultrasound therapy and the treatment will be completed in 1 week for each sample 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Permanent maxillary anteriors and premolars with symptomatic irreversible pulpitis, non-contributory medical history.
 
 
ExclusionCriteria 
Details  Internal and external resorption, extensive destruction of crown, open apices tooth, antibiotics or analgesics taken in past 3 months, root fracture, perapical lesion of size ≥ 2mm. periodontally compromised tooth, history of previous endodontic treatment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of low intensity pulsed ultrasound therapy on postoperative pain in endodontically treated tooth using visual analogue scale at 6 hour, 24 hour, 48 hour, 72 hour and 5th day. To evaluate the postoperative pain in endodontically treated tooth without ultrasound therapy using visual analogue scale at 6 hour, 24 hour, 48 hour, 72 hour and 5th day. To compare the effect the postoperative pain in endodontically treated tooth with and without the use of low intensity pulsed ultrasound therapy using visual analogue scale at 6 hour, 24 hour, 48 hour, 72 hour and 5th day  6 hour, 24 hour, 48 hour, 72 hour and 5th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   09/12/2024 
Date of Study Completion (India) 19/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 19/04/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This study is a randomized clinical trial comparing the postoperative pain in endodontically treated tooth with and without the use of low intensity pulsed ultrasound therapy that will be conducted in India. The primary outcome is to evaluate the effect of low intensity pulsed ultrasound therapy on postoperative pain in endodontically treated tooth using visual analogue scale at 6 hour, 24 hour, 48 hour, 72  hour and  5th day, to evaluate the postoperative pain in endodontically treated tooth without ultrasound therapy using visual analogue scale at 6 hour, 24 hour, 48 hour, 72  hour and  5th day, to compare the effect the postoperative pain in endodontically treated tooth with and without the use of low intensity pulsed ultrasound therapy using visual analogue scale at 6 hour, 24 hour, 48 hour, 72 hour and 5th day. Participants will be randomly allocated to each group; GROUP 1-With low intensity pulsed ultrasound  therapy (n=30) and GROUP 2–Without  low intensity pulsed ultrasound  therapy. Access opening will be done using Endo access bur and Endo Z bur according to traditional endodontic access cavity preparation. The contents of the canal will be debrided with sterile 15 k file using push pull motion. Working length will be determined 1mm short of the apex using electronic apex locator and will be confirmed by radiograph. Cleaning and shaping will be done by appropriate technique depending on the configuration of the canal. Canals will be irrigated with 2ml of 17% EDTA and final rinse with sterile saline will be done  as per the standard protocol. The teeth will be given calcium hydroxide intracanal dressing and cavit placement will be done. Low intensity ultrasound therapy will be given intraorally for 10-15 mins of time duration as per the group. In group 2, blinding will be done  by giving the placebo effect (keeping the device ON with 0 intensity). Every patient will be given a VAS scale chart to keep track of their pain at the following intervals-6 hour, 24 hours, 48 hours, 72 hours and 5th day. Obturation will be done as per the standard protocol using gutta percha and sealer on third day and second session of Low intensity ultrasound therapy will be given again for 10-15 mins of time duration. The final restoration with the composite resin will be done as a post endodontic restoration on fifth day and third session of Low intensity ultrasound therapy will be given for 10-15 mins of time duration.
 
Close