| CTRI Number |
CTRI/2022/09/045786 [Registered on: 22/09/2022] Trial Registered Prospectively |
| Last Modified On: |
04/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of antibacterial effectiveness and suture safety of different suture material in Patients Undergoing endodontic surgery |
|
Scientific Title of Study
|
Microbial Evaluation and Knot Safety of Different Suture Materials in Patients Undergoing Endodontic Microsurgery-A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi |
| Designation |
Postgraduate student |
| Affiliation |
Faculty of Dental Sciences, SGT University |
| Address |
Room no. 5, Department of conservative dentistry and endodontics
Faculty of Dental Sciences, SGT University, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8607050300 |
| Fax |
|
| Email |
prachipunia1410@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandeep S Grewal |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Faculty of Dental Sciences, SGT University |
| Address |
Room no. 5, Department of conservative dentistry and endodontics
Faculty of Dental Sciences, SGT University, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
|
| Fax |
|
| Email |
drmandeepsgrewal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandeep S Grewal |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Faculty of Dental Sciences, SGT University |
| Address |
Room no. 5, Department of conservative dentistry and endodontics
Faculty of Dental Sciences, SGT University, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
|
| Fax |
|
| Email |
drmandeepsgrewal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SGT Dental College, Hospital and Research Center, SGT University, Budhera, Gurugram. |
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
Room no. 5, Department of conservative dentistry and endodontics
Faculty of Dental Sciences, SGT University, Gurugram, Haryana,
India. 122505 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prachi |
Faculty of Dental Sciences, SGT University |
Room no. 5,
Department of
conservative dentistry
and endodontics
Faculty of Dental
Sciences, SGT
University, Gurugram,
Haryana
Gurgaon
HARYANA |
8607050300
prachipunia1410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT UNIVERSITY ETHICAL COMMITTE GURUGRAM,HARYAN A |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, (2) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Polyglactin 910 |
1 group of patient
given polyglactin 910 suture
|
| Intervention |
1.Silk suture
|
1 group of patient given silk suture after endodontic surgery |
| Intervention |
Coated Antibacterial Suture
|
1 group of patients given coated antibacterial suture |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Polypropylene suture |
1 group of patient
given polypropylene suture
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients Age 25 -45 years consenting to the surgical procedure.
2 non-contributory medical history (American Society of Anaesthesiologists class I and class II).
3 Endodontic lesions not responding to conventional root canal treatments.
4 Lesion involving not more than 1-3 roots.
5 Cooperative patients.
|
|
| ExclusionCriteria |
| Details |
1 In patients where tooth is un-restorable, inadequate root length and poor periodontal support.
2 Non-consenting patients and patients younger than 25 years of age.
3 Patients with limited mouth opening.
4 Medical history with the American Society of Anesthesiologists class III-VI.
5 Uncooperative patients.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in total bacterial count.
|
3to 5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
knot safety of different sutures. |
3 to 5 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
26/09/2022 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Once the patient is selected according to the mentioned criteria , patients will be anesthetized, a full thickness flap will be reflected followed by osteotomy. Periapical endodontic surgery will be performed with the aid of an operating microscope followed by flap approximation and suturing of the surgical site. Suture removal will be carried out 3-5 days. On the day of suture removal, all sutures will be assessed under a surgical microscope and a digital camera. Each suture will then be cut and collected using separate sterile forceps and scissors and transferred to the lab and prepared for microbial analysis.
|