CTRI

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CTRI Number

CTRI/2018/05/013657 [Registered on: 03/05/2018] Trial Registered Prospectively

Last Modified On:

28/04/2018

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To See The Occurence Of Pain By Placing Two Different Medicaments Inside the Canal in Patients With Root End Pathology

Scientific Title of Study

EFFECT OF CALCIUM HYDROXIDE AND 2%CHLORHEXIDINE GEL AS INTRACANAL MEDICAMENT ON THE INCIDENCE OF INTER-APPOINTMENT FLAREUP IN CASES WITH PERIAPICAL PATHOLOGY

Trial Acronym

ECACIFP

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	DR P Suneetha
Designation	Post graduate student
Affiliation	Narayana dental college and hospital
Address	Department of conservative dentistry and endodontics. Narayana dental college and hospital,Chintha reddy palem,Nellore 524002, Andhrapradesh, India. Kurnool ANDHRA PRADESH 524002 India
Phone	9493375230
Fax
Email	drsuneetha90@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Suneel kumar Chinni
Designation	Professor
Affiliation	Narayana dental colllege and hospital
Address	Department of conservative dentistry and endodontics. Narayana dental college and hospital,Chintha reddy palem,Nellore 524002, Andhrapradesh, Nellore ANDHRA PRADESH 524002 India
Phone	9966313666
Fax
Email	chinnisk@yahoo.com

Details of Contact Person
Public Query

Name	Dr Lavanya
Designation	Professor
Affiliation	Narayana dental college and hospital
Address	Department of conservative dentistry and endodontics. Narayana dental college and hospital,Chintha reddy palem,Nellore 524002, Andhrapradesh, Nellore ANDHRA PRADESH 524002 India
Phone	9391046354
Fax
Email	drlavanyamds@gmail.com

Source of Monetary or Material Support

Narayana Dental College and Hospital Department of conservative dentistry and endodontics. Narayana dental college and hospital,Chintha reddy palem,Nellore 524002, Andhrapradesh, India.

Primary Sponsor

Name	Narayana dental college and hospital
Address	First floor,room no:6,Department of conservative dentistry and endodontics,Narayana dental college and hospital.
Type of Sponsor	Other [Private dental college and hospital]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
P Suneetha	Narayana dental college and hospital	First floor,room no:4 Department of conservative dentistry and endodontics. Nellore ANDHRA PRADESH	9493375230 drsuneetha90@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Narayana Dental College And Hospital Institutional Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Apical periodontitis with periapical pathology,

Intervention / Comparator Agent

Type	Name	Details
Intervention	2%chlorhexidine gel	An intracanal medicament effectively disinfect the canal
Comparator Agent	Calcium hydroxide paste	routinely used intracanal medicament which effectively disinfect the root canal.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	1.Single and Multi rooted teeth having apical periodontits with periapical radiolucency will be scheduled for initial endodontic treatment. 2.Patient who has the ability to understand the use of pain scales will be provided informed consent for endodontic treatment. Patients with good systemic health.

ExclusionCriteria

Details

1.Patients with sinus tract, or facial cellulitis, root fractures, open apices(below 18yrs).
2.Patient with known allergies or contraindication to opioid or NSAIDs.
3.Patients with known allergy to local anaesthesia,sodium hypochlorite and chlorhexidine.
4.Presence of systemic diseases like
cardiovascular disease,renal disease, and any
bleeding disorders or anti coagulant use with in last month.
5. Pregnant and lactating mothers.
6.Patients with immunocompromised status.
7.Patients who are unable to complete the pain questionnaires.
8.Patients who are not willing to sign consent for
treatment.

Method of Generating Random Sequence

Stratified randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Evaluating interappointment flare-up(sudden onset of pain) by using verbal rating scale.	Evaluating pain on 1,2,3, and 7 day after treatment using verbal rating scale.

Secondary Outcome

Outcome	TimePoints
valuating interappointment flare-up(sudden onset of pain) by using verbal rating scale.	Evaluating pain on 1,2,3, and 7 day after treatment using verbal rating scale.

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
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)

10/05/2018

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="5"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

none yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

This study is randomized clinical trail to evaluate the effect of two intracanal medicament on the incidence of inter appointment flare up by using verbal rating scale, that will be conducted in narayana dental coolege and hospital.