| CTRI Number |
CTRI/2024/12/077596 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study is conducted to compare the differences between calcium hydroxide, triple antibiotic paste and triple antibiotic paste with nanoparticles used during root canal treatment. |
|
Scientific Title of Study
|
Comparative Microbiological Evaluation of Calcium Hydroxide, Triple Antibiotic Paste and Triple Antibiotic Paste with Nano Particles as Intracanal Medicaments in Symptomatic Apical Periodontitis : A Randomized Clinical Study. |
| 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 Vivek hegde |
| Designation |
Professor & H O D Department of Conservative Dentistry & Endodontics |
| Affiliation |
M A Rangoonwala dental college and hospital, pune |
| Address |
Room no.305, department of conservative dentistry and endodontics, M.A. Rangoonwala dental college and hospital azam campus 2390 B K B Hidayatullah road camp pune maharashtra.
Pune
MAHARASHTRA
411001
India |
| Phone |
9822055434 |
| Fax |
|
| Email |
drvivekhegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Hegde |
| Designation |
Professor and H.O.D |
| Affiliation |
M A Rangoonwala dental college and hospital, pune |
| Address |
Room no.305, department of conservative dentistry and endodontics, M.A. Rangoonwala dental college and hospital azam campus 2390 B K B Hidayatullah road camp pune maharashtra.
Pune
MAHARASHTRA
411001
India |
| Phone |
9822055434 |
| Fax |
|
| Email |
drvivekhegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Gaikwad |
| Designation |
Post graduate student |
| Affiliation |
M A Rangoonwala dental college and hospital, pune |
| Address |
Room no.305, department of conservative dentistry and endodontics, M.A. Rangoonwala dental college and hospital azam campus 2390 B K B Hidayatullah road camp pune maharashtra.
Pune
MAHARASHTRA
411001
India |
| Phone |
9822195885 |
| Fax |
|
| Email |
bdsakshay@gmail.com |
|
|
Source of Monetary or Material Support
|
| M A Rangoonwala dental college and hospital room number 305 department of conservative dentistry and endodontics azam campus 2390 B K B Hidayatullah road camp pune. |
|
|
Primary Sponsor
|
| Name |
Dr Vivek Hegde |
| Address |
M A Rangoonwala dental college and hospital room number 305 department of conservative dentistry and endodontics azam campus 2390 B K B Hidayatullah road camp pune. |
| 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 |
| Dr Vivek Hegde |
M A Rangoonwala dental college and hospital |
Room number 305 department of conservative dentistry and Endodontics azam campus 2390 B K B hidayatullah road camp pune.
Pune
MAHARASHTRA |
9822055434
drvivekhegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MCE societys m a rangoonwala dental college ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcium hydroxide |
Calcium hydroxide will be placed after cleaning and shaping of the root canal.
then it will be evaluated microbiologically on 14th day and 28th day. |
| Comparator Agent |
No medicament |
After cleaning and shaping of root canal no medicament will be placed. and will be evaluated microbiologically on 14th day and 28th day. |
| Intervention |
Triple antibiotic paste |
Triple antibiotic paste will be placed after cleaning and shaping of the root canal.
then it will be evaluated microbiologically on 14th day and 28th day. |
| Intervention |
Triple antibiotic paste with nano particles |
Triple antibiotic paste with nano particles will be placed after cleaning and shaping of the root canal.
then it will be evaluated microbiologically on 14th day and 28th day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient with chronic irreversible pulpitis with symptomatic apical periodontitis indicated for endodontic treatment.
Age group 18 and 50.
PAI score less than or equal to 3.
Mandibular premolars with single root and single canal.
patient who is having no necessity of antibiotics in the past 3 months.
the tooth which showed no response to thermal and electric pulp tests.
patients having no significant systemic conditions.
patients who is ready to give written informed consent. |
|
| ExclusionCriteria |
| Details |
Fractured tooth
Root resorption
Retreatment cases
Calcified canals
Tooth with Endo periodontitis lesions
Extra oral sinus tracts |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the antimicrobial efficacy of calcium hydroxide, Triple antibiotic paste and triple antibiotic paste with nanoparticles (chitosan) |
on 14th and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain |
on 24 hours, 72 hours and 7 days |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/01/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Microorganism’s present in the root canal system, causes apical periodontitis. calcium hydroxid and triple antibiotic paste is used as intra canal medicament to disinfect the root canals. this study is to compare efficacy of triple antibiotic paste with nanoparticles (chitosan) as intra canal medicament to that of triple antibiotic paste and calcium hydroxide against bacterias in the root canal system. |