Clinical Assessment of 3 Differant Obturation Sealers on Postoprative Pain and Swelling

June 13, 2022 updated by: Elsayed Hany Elsayed Attia Elmasry, Cairo University

Assessment of 3 Different Root Canal Obturating Sealers on Postoperative Pain and Swelling in Single Canal Necrotic Teeth With a Single Visit .a Randomized Controlled Trial

aim of the study will be conducted to compare the effect of MTA fill apex sealer and endo sequence bioceramic sealer in obturation on the intenisty of postoperative pain and the incidence of post operative swelling in patient with necrotic teeth .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients requiring root canal treatment of single canal necrotic teeth.
  • Patient from 18 to 60 years old
  • Patients with Asymptomatic apical periodontitis.
  • Teeth presenting with no clinical symptoms and with a periapical score from 2 to 4 according to Orstavik et al

Exclusion Criteria:

  • Teeth with incompletely formed apex

    • Teeth requiring retreatment
    • Patients having complicating systemic disease such as diabetes, malignancy, pregnancy, central nervous system disorders, Cardiovascular system disorders, respiratory disorders, asthma patients, psychiatric disorders, immunocompromised patients
    • Patients taking anti-inflammatory or antibiotics
    • Patients giving history of analgesic or antibiotic intake 1 week before treatment
    • Patients below 18 years of age

  • Patients above 65 years of age

    • Patients having history of peptic ulcer or gastrointestinal bleeding
    • Teeth affected with periodontal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: endo sequence bioceramic sealer
obturation using Endo-sequence BC sealer
Drug: bioceramic sealer
bioceramic based obturating sealer
Other Names:
  • endosequence
Experimental: MTA fill apex calcium silicate base sealer
obturation using calcium-silicates based MTA fill-apex sealer
Drug: MTA
MTA based obturating sealer
Other Names:
  • MTA fill apex
Experimental: AH plus resin sealer
obturation using AH Plus sealer
Drug: resin sealer
resin based obturating sealer
Other Names:
  • AH Plus resin sealer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of post-operative pain
Time Frame: 6 hours
Measurement of post-operative pain by Visual analogue scale
6 hours
Intensity of post-operative pain
Time Frame: 12 hours
Measurement of post-operative pain by Visual analogue scale
12 hours
Intensity of post-operative pain
Time Frame: 24 hours
Measurement of post-operative pain by Visual analogue scale
24 hours
Intensity of post-operative pain
Time Frame: 48 hours
Measurement of post-operative pain by Visual analogue scale
48 hours
Intensity of post-operative pain
Time Frame: 72 hours
Measurement of post-operative pain by Visual analogue scale
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative swelling
Time Frame: 24 hours
Yes or no yes or no
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 30, 2022

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO 23/5/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Necrotic Pulp

Clinical Trials on bioceramic sealer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe