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Post-operative Pain Reduction

Primary Purpose

Effects of the Elements

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Conventional calcium hydroxide paste
Calcium hydroxide nanoparticle
Combined Calcium hydroxide with silver nanoparticle
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effects of the Elements

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Medically free patients.

    • Patient's age between 25-50 years.
    • Sex includes both male and female.
    • Radiographic evidence of a periapical radiolucent lesion associated with tooth.
    • Necrotic pulp as indicated by thermal pulp testing.
    • No history of previous endodontic treatment of the tooth.

Exclusion Criteria:

  • • Teeth with unfavorable conditions for rubber-dam application.

    • Teeth with acute periapical abscesses swelling.
    • Medically compromised patients.
    • Immature teeth with open apices.
    • Multi rooted teeth.
    • Pregnant women.

Sites / Locations

  • Faculty of Dentistry, Minia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional calcium hydroxide paste

Calcium hydroxide nanoparticle

Combined Calcium hydroxide with silver nanoparticle

Arm Description

Application of Conventional calcium hydroxide paste

Application of Calcium hydroxide nanoparticle

Application of Combined Calcium hydroxide with silver nanoparticle

Outcomes

Primary Outcome Measures

change in post operative pain (Visual Analogue Scale)
Numerical (0-10)

Secondary Outcome Measures

Full Information

First Posted
April 6, 2020
Last Updated
April 6, 2020
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04338633
Brief Title
Post-operative Pain Reduction
Official Title
Post-operative Pain Reduction After Application of Three Intracanal Medicament Within Necrotic Root Canals and Pulp
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Recruited patients with necrotic pulp after application of conventional calcium hydroxide paste are assigned to group, Calcium hydroxide nanoparticle group and Combined Calcium hydroxide with silver nanoparticle group and record postoperative pain afterwards.
Detailed Description
The investigator will recruit patients who are found eligible to the criteria, conventional calcium hydroxide paste , Calcium hydroxide nanoparticle and Combined Calcium hydroxide with silver nanoparticle . After 48 hours, patients will be randomly assigned to removal of intracanal medication After the visit, patients will be asked to record post operative pain by Numerical Rating Scale)in a given sheet

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effects of the Elements

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional calcium hydroxide paste
Arm Type
Active Comparator
Arm Description
Application of Conventional calcium hydroxide paste
Arm Title
Calcium hydroxide nanoparticle
Arm Type
Experimental
Arm Description
Application of Calcium hydroxide nanoparticle
Arm Title
Combined Calcium hydroxide with silver nanoparticle
Arm Type
Experimental
Arm Description
Application of Combined Calcium hydroxide with silver nanoparticle
Intervention Type
Drug
Intervention Name(s)
Conventional calcium hydroxide paste
Other Intervention Name(s)
Ultracal
Intervention Description
Conventional calcium hydroxide paste (Ultracal) will be removed in second visit.
Intervention Type
Drug
Intervention Name(s)
Calcium hydroxide nanoparticle
Intervention Description
Calcium hydroxide nanoparticle. manufactured in NanoTech. institute, will be removed in second visit.
Intervention Type
Drug
Intervention Name(s)
Combined Calcium hydroxide with silver nanoparticle
Intervention Description
Combined Calcium hydroxide with silver nanoparticle will be removed in second visit.
Primary Outcome Measure Information:
Title
change in post operative pain (Visual Analogue Scale)
Description
Numerical (0-10)
Time Frame
Intrappointment at 4,24,48,72 and 96 hours ]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Medically free patients. Patient's age between 25-50 years. Sex includes both male and female. Radiographic evidence of a periapical radiolucent lesion associated with tooth. Necrotic pulp as indicated by thermal pulp testing. No history of previous endodontic treatment of the tooth. Exclusion Criteria: • Teeth with unfavorable conditions for rubber-dam application. Teeth with acute periapical abscesses swelling. Medically compromised patients. Immature teeth with open apices. Multi rooted teeth. Pregnant women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Salah Hegazi
Phone
+201224014179
Email
mshegazi2006@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Reham Hassan, Assoc Prof
Phone
+201001542529
Email
reham-hassan@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdy Mohamed Aly, Professor
Organizational Affiliation
Dean of Faculty
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Minia University
City
Minya
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reham Hassan, Assoc Prof
Phone
+201001542529
Email
reham-hassan@live.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23657409
Citation
Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
Results Reference
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Post-operative Pain Reduction

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