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CTRI Number  CTRI/2024/02/062384 [Registered on: 07/02/2024] Trial Registered Prospectively
Last Modified On: 10/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two different sutures on postoperative complications following periapical surgeries 
Scientific Title of Study   Comparison of two different sutures on postoperative complications following periapical surgeries: A prospective, randomised controlled 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 Pravin Kumar 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Jodhpur  
Address  Department of Dentistry, Block 2A, OPD Building, All India Institute of Medical Sciences Jodhpur, Rajasthan - 342005, India

Jodhpur
RAJASTHAN
342005
India 
Phone  9818402220  
Fax    
Email  kumarpr@aiimsjodhpur.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pravin Kumar  
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Jodhpur  
Address  Department of Dentistry, Block 2A, OPD Building, All India Institute of Medical Sciences Jodhpur, Rajasthan - 342005, India

Jodhpur
RAJASTHAN
342005
India 
Phone  9818402220  
Fax    
Email  kumarpr@aiimsjodhpur.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Pravin Kumar  
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Jodhpur  
Address  Department of Dentistry, Block 2A, OPD Building, All India Institute of Medical Sciences Jodhpur, Rajasthan - 342005, India

Jodhpur
RAJASTHAN
342005
India 
Phone  9818402220  
Fax    
Email  kumarpr@aiimsjodhpur.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Jodhpur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan-342005  
Type of Sponsor  Government medical college 
 
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 Pravin Kumar  All India Institute of Medical Sciences   Department of Dentistry, Block 2A, Second Floor, OPD Block, AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN 
9818402220

kumarpr@aiimsjodhpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Jodhpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K048||Radicular cyst,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  4-0 Polypropylene (Prolene) Suture  Prolene is produced by chain-growth polymerization of the propylene monomer and is pigmented blue for better visibility. Sutures will remain in place for 5 days 
Intervention  4-0 Polytetrafluoroethylene (PTFE) Suture  PTFE is a monofilament, non-absorbable, extremely soft and smooth material composed of polytetrafluoroethylene. Sutures will remain in place for 5 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All adult patients (18-65 years) presenting with Periapical lesion that requires Apicectomy. 
 
ExclusionCriteria 
Details  1) Patients with uncontrolled systemic diseases,
2) Patients who are not willing to give consent for participation in the study,
3) Extensive lesion that requires intervention under general anesthesia,
4) Lesions of non endodontic origin 
 
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 compare the efficacy of 4-0 prolene (3/8 reverse cutting) versus 4-0 PTFE suture (3/8 reverse cutting) in periapical surgeries in terms of postoperative complications.  Five days Post-operatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the 4-0 prolene (3/8 reverse cutting) versus 4-0 PTFE suture (3/8 reverse cutting) in periapical surgeries in terms of patients as well as surgeon’s satisfaction.  Five Days Post-operatively 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/02/2024 
Date of Study Completion (India) 10/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
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  

Wound closure is a key element for successful healing of surgical sites and aids in reducing postoperative complications like pain, swelling, infection, etc. Literature has advocated use of sutures, surgical clamps, and adhesive agents for securing and stabilizing detached tissues for the subsequent satisfactory healing. Sutures are the most frequently used medical device for wound closure. They support tissue during the early phase of healing until it regains enough tensile strength. Regardless of the suture material origin, its essential role is to support the tissue until continuity of surface and enough tensile strength is regained during the process of wound healing. Good sutures require specific physical characteristics and properties, such as good resistance to traction, dimensional stability, lack of memory, good knot security, and sufficient flexibility to avoid damage to the oral mucosa. At the same time, they must avoid or limit bacterial adhesion and proliferation to those parts exposed to oral fluids, thereby avoiding contamination inside the wound. A good suture material must show a brief exudative phase and must not interfere with cellular proliferation or connective tissue organization. There are many suturing materials now available in the market. These materials are classified as braided multifilament and monofilament or bio absorbable and nonabsorbable. However, the selection of suture material for periapical surgery is often based on surgeons’ choices rather than scientific data and has not been extensively investigated. Hence, we propose a randomized controlled trial to compare efficacy of 4-0 prolene (3/8 reverse cutting) versus 4-0  PTFE suture (3/8 reverse cutting) in periapical surgeries in terms of postoperative complications, along with patient as well as surgeon’s satisfaction.

 
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