| CTRI Number |
CTRI/2023/02/049775 [Registered on: 16/02/2023] Trial Registered Prospectively |
| Last Modified On: |
19/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ASSESSMENT OF HEALING OF PERIAPICAL LESIONS BY SURGICAL AND NON SURGICAL METHODS |
|
Scientific Title of Study
|
COMPARISON OF HEALING IN SURGICAL AND NON SURGICAL MANAGEMENT OF PERIAPICAL LESIONS-A RETROSPECTIVE CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P EDITH SELVA SUDASHINI |
| Designation |
MDS FIRST YEAR |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics,Room Number:6,129 CMH Compound,old Kuvayarpalayam road,East veli street
Madurai
TAMIL NADU
625001
India |
| Phone |
9442893236 |
| Fax |
|
| Email |
edithsudhashini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P EDITH SELVA SUDASHINI |
| Designation |
MDS FIRST YEAR |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics,Room Number:6,129 CMH Compound,old Kuvayarpalayam road,East veli street
Madurai
TAMIL NADU
625001
India |
| Phone |
9442893236 |
| Fax |
|
| Email |
edithsudhashini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
Professor And Head of The Department |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics,Room Number:6,129 CMH Compound,old Kuvayarpalayam road,East veli street
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSI College of Dental Sciences And Research, 129 CMH Compound ,East veli street,Madurai,TamilNadu 625001 |
|
|
Primary Sponsor
|
| Name |
CSI College of Dental Sciences And Research |
| Address |
Room number 6 129,CMH Compound,Old Kuvayarpalayam Road,East veli street,Madurai |
| 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 |
| P EDITH SELVA SUDASHINI |
CSI College of Dental Sciences and Research |
Room number:6
Department of Conservative Dentistry and Endodontics
Madurai
TAMIL NADU |
9442893236
edithsudhashini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE AND INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non-surgical root canal treatment. |
Non-surgical root canal treatment done using biodentine apical plug and thermoplasticized obturation and with follow up of 18 months months |
| Comparator Agent |
Surgical root canal treatment |
surgical root canal treatment followed by root end resection and placement of PRF and bone graft with a follow up of 18 months |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Periodontally healthy teeth.
Teeth with/without previous root canal treatment.
Necrotic maxillary and mandibular incisors, canine,premolars and molars with radiographic evidence of periapical lesion.
Necrotic maxillary incisors
|
|
| ExclusionCriteria |
| Details |
Compromised periodontal status.
Patients with systemic diseases.
Teeth not amenable to postendodontic restoration.
Teeth with evidence of vertical root fracture. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| preoperative and postoperative 3 Dimensional volumetric change of the lesion size assessed using CBCT. |
preoperative and postoperative 3 Dimensional volumetric change of the lesion size assessed using CBCTat 6 months, 12 months and 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of PAI score in baseline and follow up radiograph and CBCT. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2023 |
| Date of Study Completion (India) |
19/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Assessment of outcome healing of periapical lesions treated by Surgical and Non-surgical root canal treatment using 3Dimensional volumetric analysis with duration of follow-up of 18 months
|