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CTRI Number  CTRI/2024/11/076458 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 04/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing pain-killer coated stitches and plain stitches after removal of teeth for pain and healing. 
Scientific Title of Study   A comparative assessment between analgesic and non analgesic coated suture material in evaluation of post extraction pain and healing : A prospective split mouth study 
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 Deeyah Miriam Deepak 
Designation  Post Graduate  
Affiliation  Yenepoya Dental College 
Address  Room number -4 Dept of Oral and Maxillofacial Surgery, 1st floor, Yenepoya Dental College, Yenepoya University, Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7996377624  
Fax    
Email  deeyahmiriamdeepak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jagadish Chandra 
Designation  Head of The Department  
Affiliation  Yenepoya Dental College 
Address  Room number -4 Dept of Oral and Maxillofacial Surgery 1st floor, Yenepoya Dental College, Yenepoya University

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845150871  
Fax    
Email  jagadishmds@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deeyah Miriam Deepak 
Designation  Post Graduate  
Affiliation  Yenepoya Dental College 
Address  Room number -4 Dept of Oral and Maxillofacial Surgery 1st floor, Yenepoya Dental College, Yenepoya University


KARNATAKA
575018
India 
Phone  7996377624  
Fax    
Email  deeyahmiriamdeepak@gmail.com  
 
Source of Monetary or Material Support  
Yenepoya Dental College, University Road Deralakatte Mangalore 575018 
 
Primary Sponsor  
Name  Dr. Deeyah Miriam Deepak 
Address  Marian Aspire Flat no 201 Daddalkad 575006 
Type of Sponsor  Other [Self funded] 
 
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 Deeyah Miriam Deepak  Yenepoya Dental College   Room number -4 Dept of Oral and Maxillofacial Surgery 1st floor, Yenepoya Dental College, Yenepoya University
Dakshina Kannada
KARNATAKA 
7996377624

deeyahmiriamdeepak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee-1, Yenepoya (Deemed to be University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients who are reporting to the Department of oral surgery, Yenepoya dental college for bilateral symmetrical extractions. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Plain vicyrl 3-0  Participants who fit the inclusion and exclusion criteria after screening and after due process of informed consent will be randomised to this group (Group B) and will receive standard of care and in addition suturing of wound will be done with the interventional product (Plain Vicyrl 3–0 ) Follow up will happen after 7 days, 14 days. 
Intervention  Vicyrl 3-0 soaked in ketorolac   Participants who fit the inclusion and exclusion criteria after screening and after due process of informed consent will be randomised to this group (Group A) and will receive standard of care and in addition suturing of wound will be done with the interventional product (Vicyrl 3–0 soaked in ketorolac) Follow up will happen after 7 days, 14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients within the age of 18 – 60 years.
2.Patients with any bilateral symmetrical extractions.
3.Patients who are medically fit for the procedure. 
 
ExclusionCriteria 
Details  1. Patients who are not willing to participate in the study.
2. Pregnant or lactating mothers.
3.Patients with immunocompromised conditions and systemic diseases.
4.Clinical evidence of acute infection, inflammation or any other pathologies like periapical cyst, tumours, fractures etc. around the tooth to be extracted for the study.
5.Patients who are allergic to the analgesic drug. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess pain and healing in post extraction 1 day, 3 days and 7 days.  To assess pain and healing in post extraction 1 day, 3 days and 7 days. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess better quality of life in these patients by fore-said parameters  Follow up of 7 days  
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/11/2024 
Date of Study Completion (India) 30/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   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  

      Wound repair is a well orchestrated and highly coordinated process. Sutures serve to maintain tissue approximation until the wound attains sufficient tensional strength to prevent dehiscence. Correct closure and stabilization of surgical wound margins influence the success of the surgical procedureThe number of tissue layers involved in wound closure, the amount of tension across the sutured wound, the depth at which the suture is placed, the presence of edema, the approximate amount of time the suture must be kept in place, and the inflammatory reactions displayed by the suture material are some of the factors that influence the choice of suture material in the management of surgical wounds
Post extraction pain has often been a nemesis for dental surgeons,with clinicians perpetually striving for an analgesic modality that would provide profound analgesia and would be best tolerated by the patient, hence ensuring patient compliance.
Medications such as NSAIDS are frequently provided to patients experiencing post-surgical pain and are to be taken orally or parentarally.Long term repeated medication administrations are necessary as long term pain lasts until the wounds have nearly healed.
Gastrointestinal disturbances, Electrolytic imbalance, Fluid retention hypertension, Hyperkalemia, Hyponatremia, Reye’s syndrome, Platelet dysfunction and Renal impairment are just a few of the side effects.
Since oral medications must first pass through the liver for metabolism, there will be less bioavailability and due to high plasma concentration which leads to significant adverse effects, local  drug delivery is advantageous for reducing pain at the surgical site.
Ketorolac tromethamine is a pyrrolo -pyrrole non steroidal anti inflammatory drug with potent analgesic, anti inflammatory and antipyretic activity. Mechanism of action of Ketorolac is by inhibiting the cycloxygenase pathway of arachidonic acid metabolism, resulting in a decrease in prostaglandin and thromboxane production.
Therefore, Analgesic-coated suture can be used as a medical aid potentially suitable for local drug delivery to treat post-surgical pain.

      In this study, we will be comparing Analgesic coated suture- Ketorolac tromethamine and Non Analgesic coated suture Vicryl 3-0 post extraction to provide local drug delivery to alleviate pain and assess healing in patients by two interventions.

 

 
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