| CTRI Number |
CTRI/2020/10/028484 [Registered on: 20/10/2020] Trial Registered Prospectively |
| Last Modified On: |
19/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Disinfection of Root canal using Calcium hydroxide and Sodium hypochlorite |
|
Scientific Title of Study
|
Impact of passively placed sodium hypochlorite in a calcium hydroxide dressing on root canal disinfection and periapical tissue response: a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09880626167 |
| Fax |
|
| Email |
drballal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics
Manipal College of Dental Sciences Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09880626167 |
| Fax |
|
| Email |
drballal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics
Manipal College of Dental Sciences Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09880626167 |
| Fax |
|
| Email |
drballal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Manipal college of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences |
| Address |
Dept of Conservative Dentistry and Endodontics |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| University of Zurich |
University of Zurich |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vasudev Ballal |
Manipal College of Dental Sciences |
Department of Conservative Dentistry and Endodontics
Udupi
KARNATAKA |
09880626167
drballal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
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, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
calcium hydroxide |
calcium hydroxide paste placed as intracanal medicament for one week |
| Intervention |
sodium hypochlorite and calcium hydroxie |
Mixture of calcium hydroxide and sodium hypochlorite placed as intracanal medicament for one week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
pulpal diagnosis of necrosis and an apical diagnosis of symptomatic/asymptomatic apical periodontitis |
|
| ExclusionCriteria |
| Details |
(i) a chronic condition requiring the intake of anti-inflammatory/antibiotic drugs, (ii) tooth which cannot be isolated by rubber dam properly, (iii) a non-restorable tooth, or (iv) root canals in which patency for periapical fluid sampling cannot not be achieved |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Microbial samples from root canal |
one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| periapical markers |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
25/10/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Two types of intracanal medicament will be used (NaOCl + calcium hydroxide and calcium hydroxide alone) and the microbial samples and periapical inflammatory markers will be assessed from the teeth with pulpal necrosis. |