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Post-operative Pain Reduction

Sponsor
Minia University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04338633
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
7
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Conventional calcium hydroxide paste
  • Drug: Calcium hydroxide nanoparticle
  • Drug: Combined Calcium hydroxide with silver nanoparticle
 N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
double
Primary Purpose:
Treatment
Official Title:
Post-operative Pain Reduction After Application of Three Intracanal Medicament Within Necrotic Root Canals and Pulp
Anticipated Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2020
Anticipated Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conventional calcium hydroxide paste

Application of Conventional calcium hydroxide paste

Drug: Conventional calcium hydroxide paste
Conventional calcium hydroxide paste (Ultracal) will be removed in second visit.
Other Names:
  • Ultracal

    		•
    Experimental: Calcium hydroxide nanoparticle

    Application of Calcium hydroxide nanoparticle

    Drug: Calcium hydroxide nanoparticle
    Calcium hydroxide nanoparticle. manufactured in NanoTech. institute, will be removed in second visit.
    Experimental: Combined Calcium hydroxide with silver nanoparticle

    Application of Combined Calcium hydroxide with silver nanoparticle

    Drug: Combined Calcium hydroxide with silver nanoparticle
    Combined Calcium hydroxide with silver nanoparticle will be removed in second visit.

    Outcome Measures

    Primary Outcome Measures

    1. change in post operative pain (Visual Analogue Scale) [Intrappointment at 4,24,48,72 and 96 hours ]]

      Numerical (0-10)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry, Minia University Minya Egypt

    Sponsors and Collaborators

    • Minia University

    Investigators

    • Study Director: Magdy Mohamed Aly, Professor, Dean of Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed Salah Mohamed Fahmy, PHD Candidate - Endodontic Department- Faculty of Dentistry, Minia University
    ClinicalTrials.gov Identifier:
    NCT04338633
    Other Study ID Numbers:
    • 314
    First Posted:
    Apr 8, 2020
    Last Update Posted:
    Apr 8, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Calcium, Dietary
    Calcium

    Study Results

    No Results Posted as of Apr 8, 2020