| CTRI Number |
CTRI/2020/03/024319 [Registered on: 27/03/2020] Trial Registered Prospectively |
| Last Modified On: |
23/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
|
Effect of different medicine to be placed inside the tooth canal, on the pain after root canal treatment |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of three intracanal medicaments on post-operative pain- A randomized control trial |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Sharma |
| Designation |
Post graduate student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of conservative dentistry and endodontics, second floor, room number 7. Manav Rachna Dental College, Sector 43,Suraj Kund Badkhal Road, Faridabad
Faridabad
HARYANA
1211004
India |
| Phone |
8544947590 |
| Fax |
|
| Email |
sgarima56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dax Abraham |
| Designation |
Professor and head of the department |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of conservative dentistry and endodontics, second floor, room number 7. Manav Rachna Dental College, Sector 43,Suraj Kund Badkhal Road, Faridabad
Faridabad
HARYANA
1211004
India |
| Phone |
9910433111 |
| Fax |
|
| Email |
daxabraham.mrdc@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dax Abraham |
| Designation |
Professor and head of the department |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of conservative dentistry and endodontics, second floor, room number 7. Manav Rachna Dental College, Sector 43,Suraj Kund Badkhal Road, Faridabad
Yamunanagar
HARYANA
1211004
India |
| Phone |
9910433111 |
| Fax |
|
| Email |
daxabraham.mrdc@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
| Self funded. Materials will be funded by college- Manav Rachna Dental College, Sector 43,Suraj Kund Badkhal Road, Faridabad |
|
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Primary Sponsor
|
| Name |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College, Sector 43,Suraj Kund Badkhal Road, Faridabad |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Garima Sharma |
Manav Rachna Dental College |
Department of conservative dentistry and endodontics. Room no.7, second floor, Manav Rachna Dental College, Sector 43,Suraj Kund Badkhal Road, Faridabad
Faridabad
HARYANA |
8544947590
sgarima56@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human volunteers with mandibular molar teeth where the pulps were necrosed |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention 1-Calcium hydroxide;
Calcium hydroxide 1mg/ml using lentulospiral.
Intervention 2- Double antibiotic paste;
Double antibiotic paste 1mg/ml using syringe
Intervention 3- Chlorhexidine;
Chlorhexidine 3ml using syringe for 7 days in respective groups. |
Calcium hydroxide, double antibiotic paste and chlorhexidine used and placed as intracanal medicament in intervention group |
| Comparator Agent |
No medication used in root canal (Placebo) |
No intracanal medicament will be used in the root canal |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Mandibular molar teeth diagnosed with necrosis and symptomatic apical periodontitis.
-Teeth with mature apices.
-Teeth with multiple root canals.
-Non-use of anti-inflammatory drugs and analgesics within the last 6 hours
|
|
| ExclusionCriteria |
| Details |
-Patients with any systemic disease.
-Mobile teeth.
-Pregnant or lactating women.
-Patients with history of allergy to LA
-Teeth associated with fluctuant facial swelling.
-Teeth with previous RCT.
-Teeth with internal root resorption.
-Teeth with severe damage |
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Post- operative pain |
Post- operative pain will be evaluated after 6,24,48 and 72 hours and consecutively for 4 more days with the help of heft parker scale |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcomes |
No secondary outcomes |
|
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Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/04/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
For many years pain of endodontic origin has been a chief concern to the patients and the clinicians(1). It may occur as a result of several factors, including chemical, mechanical or bacterial irritation to periapical tissues(2). In order to reduce pain, and regarding the recommendation of treating necrotic teeth, intra-canal medicaments can be used between sessions(3). The choice of which intracanal medicament to use rely on having an accurate diagnosis of the condition being treated(4). Calcium hydroxide has been used in dentistry for almost a century(5). It is characterized by its initial bactericidal, bacteriostatic effect and its high ph. It has been suggested that calcium hydroxide has pain preventive characteristics due to antibacterial action or tissue altering effects(2). Its use in root canal treatment as an intracanal medicament has been associated with periradicular healing(5). Chlorhexidine gluconate (CHX) is a broad-spectrum antimicrobial agent that has been advocated as an effective medication in endodontic therapy(6). Chlorhexidine is a cationic bisguanide used in apical periodontitis that seems to act by adsorbing into the cell wall of micro-organism and causing leakage of intracellular components. Its cationic structure provides a unique property named substantivity(7). At low concentration chlorhexidine has bacteriostatic effect and at high concentration it has bactericidal effect because of precipitation and /or coagulation of intracellular components(5). Double antibiotic paste (DAP) is a mixture of metronidazole and ciprofloxacin, which is used as intracanal medication for disinfection of necrotic teeth. It has been reported to be effective at reducing bacterial counts in infected root canals(2). The use of DAP was suggested to overcome the discoloration problem associated with minocycline in triple antibiotic paste. Pre-operative and post-operative pain to be recorded by Heft Parker Visual Analogue scale(8). The aim of the current study is to compare and evaluate the efficacy of three intracanal medicaments on post-operative pain - a randomized control trial. AIM To evaluate and compare the efficacy of three intracanal medicaments on post-operative pain
OBJECTIVE To evaluate and compare the efficacy of three intracanal medicaments on post-operative pain SAMPLE SELECTION Patients with necrosis and symptomatic apical periodontitis on mandibular first or second molars reporting to Department of Conservative Dentistry & Endodontics at Manav Rachna Dental College, Faridabad. Informed Consent will be taken. SAMPLE SIZE- 96 The study shall evaluate the difference of means in experimental groups. Taking alpha and beta errors of 0.05 and 0.20, at least 24 patients are required to detect a 15% difference in the mean pain score of different groups, considering a standard deviation of 18 in mean pain score. Power of study- 80% STUDY DESIGN- Interventional study (Randomized Control Trial) INCLUSION CRITERIA • Mandibular molar teeth diagnosed with necrosis and symptomatic apical periodontitis. • Teeth with mature apices. • Teeth with multiple root canals. • Non-use of anti-inflammatory and analgesics. • Healthy persons with age 18-65 years • The ‘faint, weak or mild’ pre-operative pain corresponding to ≤54 mm on HP-VAS will be taken EXCLUSION CRITERIA • Patients with any systemic disease. • Mobile teeth. • Pregnant or lactating women. • Patients with history of allergy to any of the components. • Teeth associated with fluctuant facial swelling • Teeth with previous RCT. • Teeth with root resorption. • Teeth with severe damage. METHODOLOGY N= 96
(mandibular 1st or second molar, permanent teeth with mature apices) Patients were asked to complete the Heft Parker VAS before local anesthesia Pulp vitality tests performed, and teeth are anaesthetized using LA containing 2% lidocaine with 1:80000 epinephrine Disinfection of surrounding areas will be done and tooth will be isolated with rubber dam Access opening establish patency with 15k file. Occlusion will be relieved and working length is determined with the help of electronic apex locator and periapical radiograph. Root canals are prepared using Niti rotary files. During instrumentation process, each canal is irrigated with 5 ml of 3% sodium hypochlorite and saline using 30-gauge needle placed 0.5 mm short of working length. Patients will be randomly divided into 4 groups. Randomization to be done using online random generator on randomization.com GROUPING GROUP A GROUP B GROUP C GROUP D GROUP A = CALCIUM HYDROXIDE GROUP GROUP B = DOUBLE ANTIBIOTIC PASTE GROUP C = 2% CHLORHEXIDINE GROUP GROUP D = CONTROL GROUP GROUP A-Each canal will be irrigated with 3 ml of 17% EDTA for 1 minute and then 5 ml of 3% sodium hypochlorite for 2 minutes. Canals will be irrigated with 5 ml of saline, dried and medicated with calcium hydroxide paste plugged into the canals by using lentulospiral. GROUP B- Each canal is irrigated with 3 ml of 17% EDTA for 1 minute and then 5 ml of 3% sodium hypochlorite for 2 minutes. Canals will be irrigated with 5 ml of saline, dried and medicated with double antibiotic paste plugged into the canals by using syringe GROUP C- Each canal is irrigated with 3 ml of 17% EDTA for 1 minute and then 5 ml of 3% sodium hypochlorite for 2 minutes. Canals will be irrigated with 5 ml of saline, dried and filled with 2% chlorhexidine gluconate solution using syringe. GROUP D- No dressing. (Control group) In all respective groups, temporary dressing is given, and patient is recalled after 1week. By using Heft Parker VAS post-operative pain will be evaluated at 6, 24, 48, 72 hours and consecutively for 4 more days After 1 week, root canals are obturated using cold lateral condensation technique with gutta percha and AH plus sealer. STATISTICAL ANALYSIS
The data will be statistically analysed using suitable statistical test such as ANOVA test or Kruskal- Wallis test.
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