Effect of Ascorbic Acid Final Flush on Post-operative Pain in Mandibular Molars.

July 27, 2022 updated by: Kariman Mohammed Mohammed Amin Ismaiel, Cairo University

Effect of Ascorbic Acid as a Final Flush on Post-operative Pain After Single Visit Root Canal Treatment for Patients With Symptomatic Irreversible Pulpits Related to Mandibular Molars: Randomized Controlled Trial.

The study is conducted to evaluate the effect of Ascorbic acid as a final flush on post operative pain after single visit root canal treatment in cases with symptomatic irreversible pulpits.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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

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

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients above 18 years old and to 60.
  • Male or female.
  • Patients seeking root canal treatment.
  • mandibular molar teeth with symptomatic irreversible pulpits with preoperative acute or moderate pain with hot and cold stimulation with normal periapical radiographic appearance .
  • healthy patient (ASA I,II).
  • Patient who can understand NRS and sign informed consent.

Exclusion Criteria:

  • Medically compromised patients having significant systemic disorders. (ASA III or IV).
  • History of intolerance to NSAIDS.
  • External root resorption.
  • Internal root resorption.
  • Vertical root fracture.
  • Periapical lesion.
  • Pregnancy.
  • Use of ibuprofen in the last 12 hour.
  • Bleeding disorder.
  • Long term corticosteroid use.
  • Mobility Grade II or III.
  • Pocket depth more than 5mm.
  • Previous root canal therapy.
  • Non-restorability.
  • TMJ problems, bruxism, clenching or traumatic occlusion.
  • Inability to perceive the given instructions.

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: Ascorbic acid
Ascorbic acid IV ampoules 20% as a final flush irrigation 3ml after cleaning and shaping.
Drug: Ascorbic acid
Ascorbic acid IV ampoules (20%).
Other Names:
  • Vitamin C
Placebo Comparator: Saline
A mixture of sodium chloride and water (0.9%) as a final flush irrigation 3 ml after cleaning and shaping.
Other: saline
saline (0.9%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity measured by numerical rating scale where 0= no pain, 1-3= mild pain, 4-6= moderate pain and 7-10= severe pain.
Time Frame: up to 48 hours after root canal treatment.
up to 48 hours after root canal treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
If there are analgesics taken by the patient after root canal treatment and that will be measured by a questionnaire.
Time Frame: up to 48 hours.
up to 48 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)

August 1, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

July 24, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO 3 - 7 - 1

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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