| CTRI Number |
CTRI/2026/02/104161 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the reduction in pain and swelling in dental infection causing swelling by using one visit root canal treatment accompanied by drainage of pus through an incision |
|
Scientific Title of Study
|
Assessing the effectiveness of single- visit root canal treatment with incision and drainage as treatment option for acute periapical abscess |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hema Shri P |
| Designation |
Post Graduate student |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Room no:6 , Department of Conservative Dentistry and Endodontics
129, East Veli Street
CSI College of Dental Sciences and Research
Madurai
TAMIL NADU
625001
India |
| Phone |
9043557485 |
| Fax |
|
| Email |
hemajp21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor Department of Conservative Dentistry and Endodontics |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Room no:6 , Department of Conservative Dentistry and Endodontics
129, East Veli Street
CSI College of Dental Sciences and Research
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor Department of Conservative Dentistry and Endodontics |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Room no:6 , Department of Conservative Dentistry and Endodontics
129, East Veli Street
CSI College of Dental Sciences and Research
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hema Shri P |
| Address |
Room no:6 , Department of Conservative Dentistry and Endodontics
129, East Veli Street
CSI College of Dental Sciences and Research
Madurai 625001
Tamil Nadu
India
|
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Hema Shri P |
CSI College Of Dental Sciences and Research |
Room no:6 , Department of Conservative Dentistry and Endodontics ,
129, East Veli Street
CSI College of Dental Sciences and Research
Madurai
TAMIL NADU |
9043557485
hemajp21@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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Single visit root canal treatment with Incision and drainage |
single visit root canal treatment using chlohexidine solution sonic irrigation after biomechanical preparation followed by incision and drainage.
Intervention is done once during the first visit.
Treatment will take an average of 40minutes to 60minutes to get over completely. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who show symptoms of pain and swelling that is persistent for not more than 3days that is associated with a decayed tooth
2.No sinus tract or fistula associated with the swelling
|
|
| ExclusionCriteria |
| Details |
1.Patients who show symptoms of pain and swelling for over few weeks or months that is associated with a decayed tooth
2. Patients who show systemic manifestations like fever , malaise , lymphadenopathy
3.Patients who are immunocompromised |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the pre and post operative pain scores on Visual Analogue Scale
2.Photographs to compare pre and postoperative facial swelling |
24hours , 48hours and 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the healing and prognosis |
36 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
20/03/2026 |
| 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="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study uses single visit root canal treatment with incision and drainage as treatment option for patients presenting with acute periapical abscess. This is to be evaluated using Visual Analogue scale and intraoral and extraoral photographs. |