| CTRI Number |
CTRI/2025/04/084565 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A study to compare efficacy of calcium hydroxide versus non antibiotics as intra canal medicament |
|
Scientific Title of Study
|
Comparative evaluation of anti microbial efficacy and post operative pain after using calcium hydroxide, lignocaine, lignocaine with ibuprofen, lignocaine with diclofenac as intra canal medicament in teeth with symptomatic apical periodontitis - A randomised control 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 |
Uma Bharathi B |
| Designation |
Post graduate student |
| Affiliation |
Tamil Nadu Government Dental college & hospital |
| Address |
Tamil Nadu Government Dental college Hospital
Department of Conservative Dentistry and endodontics
Room no-110
Muthuswamy salai
Near TNPSC building
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
8754186070 |
| Fax |
|
| Email |
umabharathi17@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAMAPRABHA B |
| Designation |
MDS (PROFESSOR) |
| Affiliation |
Tamilnadu government dental college |
| Address |
Tamil Nadu Government Dental College,
Department of Conservative Dentistry and Endodontics,
Room no-110
Muthuswamy salai,
George town,
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9940666344 |
| Fax |
|
| Email |
isharamah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRAMAPRABHA B |
| Designation |
MDS (PROFESSOR) |
| Affiliation |
Tamilnadu government dental college |
| Address |
Tamil Nadu Government Dental College and Hospital,
Department of Conservative Dentistry and Endodontics,
Room no-110
Muthuswamy salai,
George Town,
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9940666344 |
| Fax |
|
| Email |
isharamah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tamil Nadu Government Dental College and Hospital,No.2,Frazer Bridge road,George Town,Chennai-600003 |
|
|
Primary Sponsor
|
| Name |
Uma Bharathi B |
| Address |
Tamil Nadu Government Dental college and Hospital
Muthuswamy salai
Near TNPSC building
Chennai 600003 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DrUma Bharathi B |
Tamil Nadu Goverment Dental College & Hospital |
Department of Conservative dentistry and Endodontics,Room no-110,NO.2,Frazer bridge road,Chennai-600003
Chennai
TAMIL NADU |
8754186070
umabharathi17@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tamil Badu Government Dental College and Hospital Institutional Ethical Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium Hydroxide |
Intra canal medicament for 7 days |
| Intervention |
Lignocaine |
Intra canal medicament for 7 days |
| Intervention |
Lignocaine with Diclofenac |
intra canal medicament for 7 days |
| Intervention |
Lignocaine with Ibuprofen |
Intra canal medicament for 7 days |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with age group 17-45 years of either gender presenting non vital tooth with symptomatic apical periodontitis of maxillary central incisor. 2) Patients with no systemic disease.
3)Periodontally healthy individuals
4)Patients with good oral hygiene.
5)Patients with pre operative pain scores ranging from moderate to severe (4-10) on a Visual Analog Scale
6)Patients willing for voluntary participation & have signed informed Consent. |
|
| ExclusionCriteria |
| Details |
1)Tooth with calcified pulp chambers
2) Open apices
3)Root canal retreatment cases
4) Patients under antibiotic medications
5)Grossly decayed tooth
6)Root resorption
7)Root caries
8)Fractures
9)Previous endodontic treatment
10)Allergic reaction to lignocaine , ibuprofen , diclofenac
11)Patients who have taken analgesic or anti inflammatory drugs within 12 hours pre operatively 12)Patient with contributory medical history
13) Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in intra canal microbial count |
one week for reduction in microbial count
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in post operative pain |
48 hours for post operative pain |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
21/04/2025 |
| 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="6"
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 randomised control trial is to compare calcium hydroxide, lignocaine, lignocaine with diclofenac , lignocaine with ibuprofen as intra canal medicament conducted in TamilNadu Government Dental College and Hospital among 56 patients of age group 17 to 45 years with symptomatic apical periodontitis. The primary outcome should be reduction in microbial count after one week using culture test.Secondary outcome was reduction in post operative pain within 48 hours using Visual Analogue Scale. |