Influence of Intra Canal Medications on Postoperative Flare-up in Endodontic Re-treatment Cases

September 9, 2017 updated by: rayan rabie dahab

Influence of Calcium Hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra Canal Medicaments on Postoperative Flare -up Following Two-Visits Endodontic Retreatment Cases: Single Blinded Randomized Clinical Trial

Is to evaluate the influence of the calcium hydroxide / chlorhexidine combination and calcium hydroxide alone as an intra-canal medication in postoperative flare-up in two visits endodontic retreatment cases

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Problem: patient needs retreatment Intervention: calcium hydroxide chlorhexidine combination as an intra-canal medicament Control: calcium hydroxide alone as an intra-canal medicament Outcome: postoperative flare-up (pain and swelling) Time: after 7 days from 1st visit. population will be examined:

  1. Patients' needs retreatment.
  2. Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
  3. Age range is between 20 and 50 years.
  4. Patients who can understand the categorical tool (points)for measurement
  5. Patients able to sign informed consent.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Patients' needs retreatment.
  • 2. Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
  • 3. Age range is between 20 and 50 years.
  • 4. Patients who can understand the categorical tool (points)for measurement
  • 5. Patients able to sign informed consent.

Exclusion Criteria:

  • 1) Complicating systemic disease
  • 2) Having severe pain and/or acute apical abscesses
  • 3) Being under 18 years of age
  • 4) Using antibiotics or corticosteroids,
  • 5) having multiple teeth that required retreatment to eliminate the possibility of pain referral
  • 6) Having root canals that could not be treated well with initial root canal treatment.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: calcium hydroxide chlorhexidine
intervention: calcium hydroxide chlorhexidine combination an intra-canal medication composed of calcium hydroxide powder and chlorhexidine solution as a combination to be administered as intra-canal paste for decreasing postoperative symptoms
Combination product: calcium hydroxide chlorhexidine combination
Endodontic intra-canal medicament used for decreasing postoperative signs ans symptoms
Other Names:
  • intra-canal medicament combination
Active Comparator: calcium hydroxide
intervention: calcium hydroxide an intra-canal medicament composed of calcium hydroxide paste for decreasing postoperative symptoms and signs .
Other: calcium hydroxide intra-canal medicament
Endodontic intra-canal medicament used for decreasing postoperative signs and symptoms.
Other Names:
  • calcium hydroxide, gold standard intra-canal medicament

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measuring patients postoperative pain and swelling following endodontic re-treatment sessions using Categorical (4 points) unit using questionnaire.
Time Frame: 7 days between the 2 visits ( one week)

postoperative pain and swelling will be measured by:Categorical (4 points). The incidence of postoperative discomfort was recorded and expressed as numbers and percentages

Subjectively into 4 points:

  1. no pain
  2. Mild pain: recognizable but not discomforting pain that required no analgesics.
  3. Moderate pain: discomforting but bearable pain(analgesics if used were effective in relieving pain)
  4. Severe pain: difficult to bear (analgesics were effective in relieving pain). Patients with severe postoperative pain and/or occurrence of swelling were classified as flare-ups.3 Objectively : percussion test
7 days between the 2 visits ( one week)

Collaborators and Investigators

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

Sponsor

rayan rabie dahab

Collaborators

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)

September 1, 2017

Primary Completion (Anticipated)

March 13, 2018

Study Completion (Anticipated)

April 13, 2018

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 9, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2017-02-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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