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CTRI Number  CTRI/2022/03/041260 [Registered on: 22/03/2022] Trial Registered Prospectively
Last Modified On: 16/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison between kinesio taping and intravenous dexamethasone over post operative effect after removal unerupted lower third molar. 
Scientific Title of Study   Comparison between effectiveness of non invasive kinesio taping and intravenous dexamethasone on post operative morbidity after impacted mandibular third molar surgery – A Split mouth study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chithra A 
Designation  Associate professor 
Affiliation  MCODS , Manipal 
Address  Room No. 4, Department of oral and maxillofacial surgery , MCODS, Manipal
Room No. 4, Department of oral and maxillofacial surgery , MCODS, Manipal
Udupi
KARNATAKA
575001
India 
Phone  9481939772  
Fax    
Email  chitra.a@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Chithra A 
Designation  Associate professor 
Affiliation  MCODS , Manipal 
Address  Room No. 4, Department of oral and maxillofacial surgery , MCODS, Manipal
Room No. 4, Department of oral and maxillofacial surgery , MCODS, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9481939772  
Fax    
Email  chitra.a@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Chithra A 
Designation  Associate professor 
Affiliation  MCODS , Manipal 
Address  Room No. 4, Department of oral and maxillofacial surgery , MCODS, Manipal
Room No. 4, Department of oral and maxillofacial surgery , MCODS, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9481939772  
Fax    
Email  chitra.a@manipal.edu  
 
Source of Monetary or Material Support  
Manipal college of dental sciences , Manipal Academy of higher education, Manipal Udupi district - 576104 
 
Primary Sponsor  
Name  Manipal college of dental sciences Manipal 
Address  manipal college of dental sciences , manipal 576104 udupi district 
Type of Sponsor  Research institution and hospital 
 
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 
Abhijith S M  Manipal college of dental sciences, Manipal  room np. 4 Department of oral and maxillofacial surgery MCODS, Manipal
Udupi
KARNATAKA 		 9535060459

maxfacs20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth, ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  intravenous dexamethasone  After randomization in the control group surgical extraction of tooth will be performed on patient under local anesthesia. Immediately after surgical extraction in control group intravenous 8mg dexamethasone administration will be given post operatively. Post operatively routine antibiotics – tablet Augmentin and metronidazole and analgesics – tablet combiflam will be given for the patients as the standard regimen. wound inspection and chlorhexidine irrigation as per our OPD routine standard protocol on post op day 3. Measurements of post-operative edema, trismus and assessment of pain will be done twice postoperatively in OPD on POD-3 and POD-7  
Intervention  kinesio taping  After randomization in the test group surgical extraction of tooth will be performed on patient under local anesthesia. Immediately after surgical extraction of tooth skin will be cleaned and three equal strips of kinesio tape to be applied extending from the supraclavicular to the position of highest swelling. Only kinesio tape will be applied over the surgical site extra orally. Rescue medications will be given to patient of only test group after the procedure and will be advised to take in case of inadequate control of edema and pain. The intervention group will not be receiving intravenous dexamethasone administration. At first visit only one side will be addressed, the other side procedure will be done after healing of previously operated area i.e. approximately after 15 days. Post operatively routine antibiotics – tablet Augmentin and metronidazole and analgesics – tablet combiflam will be given for the patients as the standard regimen. KT is placed along the direction of the lymphatic duct over the sub-mental, submandibular, cervical, pre-auricular, and parotid lymph nodes. All taping procedures will be accomplished by the same operating surgeons. Removal of KT will be done on third postoperative day along with wound inspection and chlorhexidine irrigation as per our OPD routine standard protocol. Measurements of post-operative edema, trismus and assessment of pain will be done twice postoperatively in OPD on POD-3 and POD-7. Duration of application of tape will be 3 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Student population preferred over others.
Patient who have bilateral mandibular third molar impaction with difficulty index greater than 5.
Patients with no systemic illness.
Patients who are willing to get surgery done under local anesthesia in OPD.
Patient who are well oriented to time, space and should be able to give consent.
 
 
ExclusionCriteria 
Details  Patients with a history of systemic illness.
Patients with age < 18years and > 40years
Pregnant patients and lactating women.
Patients with known allergy to drugs.
Patients with history of allergy to tape.
Patients who are not willing to shave facial hair before surgery.
Patients with swelling due to active infection or Pericoronitis
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of kinesio tape in reduction of post-operative edema, trismus and pain when compared with intravenous administration of dexamethasone  Effectiveness of kinesio tape in reduction of post-operative edema, trismus and pain when compared with intravenous administration of dexamethasone.
swelling, trismus and pain will be assessed baseline, post operative day 3 and post operative day 7.  
 
Secondary Outcome  
Outcome  TimePoints 
Disadvantages of kinesio taping from esthetic aspect of the patient and their acceptance of kinesio tape over steroids post operatively  1. post operative day 3
2. post operative day 7 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   01/04/2022 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Evaluation of the patient - Thorough history and clinical examination shall be taken from the patient including details of the associated comorbidities. After thorough Radiographic evaluation and diagnosis difficulty index of the impacted tooth will be assessed bilateral side. Patient will be categorized into test and control group by chit randomization. After randomization in the test group surgical extraction of tooth will be performed on patient under local anaesthesia. Immediately after surgical extraction of tooth skin will be cleaned and three equal strips of kinesio tape to be applied extending from the supraclavicular to the position of highest swelling and in control group intravenous 8mg dexamethasone administration will be given pre operatively as per standard OPD protocol. The test group will not be receiving intravenous dexamethasone administration and only kinesio tape will be applied over the surgical site extra orally. Rescue medications will be given to patient of only test group after the procedure and will be advised to take in case of inadequate control of edema and pain.

At first visit only one side will be addressed, the other side procedure will be done after healing of previously operated area i.e. approximately after 15 days. Post operatively routine antibiotics –  tablet Augmentin and metronidazole and analgesics – tablet combiflam will be given for the patients as the standard regimen.

KT is placed along the direction of the lymphatic duct over the sub-mental, submandibular, cervical, pre-auricular, and parotid lymph nodes. All taping procedures will be accomplished by the same operating surgeons. Removal of KT will be done on third postoperative day along with wound inspection and chlorhexidine irrigation as per our OPD routine standard protocol. Measurements of post-operative edema, trismus and assessment of pain will be done twice postoperatively in OPD on POD-3 and POD-7 in both groups.

 
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