| 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
|
|
|
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
|
|
|
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. |