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CTRI Number  CTRI/2024/11/076441 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 27/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Assessing the Effectiveness of Aqua Titan Patch in Reducing Postoperative Complications After Wisdom Tooth Surgery: A Randomized Control Trial 
Scientific Title of Study   EVALUATION OF EFFICACY OF AQUA TITAN PATCH IN POSTOPERATIVE SEQUELAE AFTER IMPACTED MANDIBULAR THIRD MOLAR SURGERY – A RANDOMIZED CONTROL 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 Neha Patel 
Designation  Post graduate student 
Affiliation  Geetanjali Dental and Research Insitute 
Address  Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001

Udaipur
RAJASTHAN
313001
India 
Phone  9265940764  
Fax    
Email  patelnehac44@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shallu Bansal 
Designation  Professor & Head  
Affiliation  Geetanjali Dental and Research Insitute 
Address  Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001

Udaipur
RAJASTHAN
313001
India 
Phone  9116155666  
Fax    
Email  drshallu23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shallu Bansal 
Designation  Professor & Head  
Affiliation  Geetanjali Dental and Research Insitute 
Address  Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001


RAJASTHAN
313001
India 
Phone  9116155666  
Fax    
Email  drshallu23@gmail.com  
 
Source of Monetary or Material Support  
Geetanjali Dental And Research Institute,Geetanjali University, Udaipur 
 
Primary Sponsor  
Name  Geetanjali Dental & Research Institute 
Address  Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001  
Type of Sponsor  Research institution 
 
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 Shallu Bansal  Geetanjali Dental & Research Institute, Udaipur  Geetanjali Dental & Research Institute MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA
Udaipur
RAJASTHAN 
9116155666

drshallu23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human research ethic committee of Geetanjali university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  aqua titan patch  aqua titan patch will be used to rule out the efficacy in post operative pain, swelling and trismus after impacted mandibular third molar surgery 
Comparator Agent  dynaplast as a placebo  Dynaplast as a placebo will be compared with aqua titan patch after impacted mandibular third molar surgery in post operative sequalae.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients between age of 18-45 years of both genders.
2. Patients indicated for surgical removal of impacted mandibular third molar.
3. Healthy patients falling under ASA I and ASA II
4. Subjects able and willing to provide written informed consent and compliant with study procedure.
 
 
ExclusionCriteria 
Details  1. Patients with mouth opening less than 30mm.
2. Patient with allergy with NSAIDS.
3. Patients having history of drug abuse.
4. Patients having any systemic or local immunodeficiency.
5.Patient is under regular analgesics and anti-depressants.
•Having any blood coagulation impairment.
•Presence of any acute oral infection.
•Have been suffering with uncontrolled diabetes or other systemic diseases.
•Having previous history of radiation therapy in the head and neck region.
•Pregnant and nursing women.
•Soft tissue impactions.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain
Swelling
Trismus 
all these parameters will be measured on 1st, 3rd and 7th post operative day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   12/11/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Extraction of mandibular third molar is most accomplished procedure in oral surgery. The prevalence of impacted lower third molar ranges from 16.7% - 68.8%. Indication for third molar surgery includes pericoronitis, periodontal defect on distal aspect of 2nd molar, dental caries, involvement of mandibular 3rd molar in various odontogenic tumors and cyst and 6 months prior to Bilateral sagittal split osteotomy.

 

Pain, oedema, and trismus are the most common post-operative sequalae after surgical removal of the mandibular third molar which may affect the quality of life of the patient. These post-operative sequelae further depend upon the location, depth, tooth angulation, bone density and duration of the surgery. Various studies had been done in literature with various methods to improve the control of pain, oedema, and trismus and to accelerate postoperative recovery period. 

 

These attempts include use of various anesthesia alone and in combinations, corticosteroids, incorporation of drains, platelet rich-plasma, using high or low speed rotatory instruments for osteotomy, cryotherapy, postoperative ice-packs, lasers, and physiotherapy. 

 

Titanium has been reported to have beneficial physiological effects such as anti-inflammatory, anti-tumor, anti-oxidant, and stimulation of nerve cell growth. As per Rowlands et al  the application of aqua titan patch has been advantageous for the repair of muscle-tendon components. Basically, aqua titan is a material compromising microscopic titanium particles dispersed in water, achieved through a processing technology, developed by phiten co. (Kyoto, Japan). Aqua titan can be applied to many products in collaboration with other materials to promote health in daily life and has received attention recently in variety of fields. 

 

Nishiyama et al  reported that aqua titan- permeated patches are beneficial in relieving TMD- related pain in improving TMD-related limitation to daily function by local application to most painful area, including the muscle and joints of patients and advantages for relieving muscle pain.

 

There are ample number of studies in literature regarding the use of NSAIDS, steroids, PRP, PRF, lasers, cryotherapy for the management of post-operative pain, swelling and trismus. As per best  of our knowledge, there is scarcity of literature regarding the use of aqua titanium patch for the management of pain, swelling and trismus after impacted mandibular third molar surgery.

Therefore, the present study will be done to evaluate the efficacy of aqua titanium patch in post- operative sequel after mandibular third molar surgery 
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