NCT04338633

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

April 6, 2020

Last Update Submit

April 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in post operative pain (Visual Analogue Scale)

    Numerical (0-10)

    Intrappointment at 4,24,48,72 and 96 hours ]

Study Arms (3)

Conventional calcium hydroxide paste

ACTIVE COMPARATOR

Application of Conventional calcium hydroxide paste

Drug: Conventional calcium hydroxide paste

Calcium hydroxide nanoparticle

EXPERIMENTAL

Application of Calcium hydroxide nanoparticle

Drug: Calcium hydroxide nanoparticle

Combined Calcium hydroxide with silver nanoparticle

EXPERIMENTAL

Application of Combined Calcium hydroxide with silver nanoparticle

Drug: Combined Calcium hydroxide with silver nanoparticle

Interventions

Conventional calcium hydroxide paste (Ultracal) will be removed in second visit.

Also known as: Ultracal
Conventional calcium hydroxide paste

Calcium hydroxide nanoparticle. manufactured in NanoTech. institute, will be removed in second visit.

Calcium hydroxide nanoparticle

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

Combined Calcium hydroxide with silver nanoparticle

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Minia University

Minya, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23657409BACKGROUND

MeSH Terms

Interventions

UltraCal XS

Study Officials

  • Magdy Mohamed Aly, Professor

    Dean of Faculty

    STUDY DIRECTOR

Central Study Contacts

Mohamed Salah Hegazi

CONTACT

Reham Hassan, Assoc Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD Candidate - Endodontic Department- Faculty of Dentistry

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 8, 2020

Study Start

April 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations