The Effect of Using 70% Ethanol Alcohol as a Root Canal Irrigant on Increasing the Success Rate of Metapex in Pulpectomy Compared to Normal Saline in Primary Molars

July 24, 2021 updated by: Thamar Al-Gannah Samy Rashed, Cairo University

Clinical and Radiographic Evaluation of 70% Ethanol Alcohol Versus Normal Saline as Root Canal Irrigating Solutions in Partial Pulpectomy of Primary Molars With Metapex A Randomized Controlled (Pilot Trial)

The aim of the study is to perform a clinical and radiographic evaluation of 70% Ethanol Alcohol versus Normal Saline as root canal irrigating solutions in partial pulpectomy of primary molars with Metapex.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In permanent dentition, Calcium Hydroxide-Iodoform paste (Metapex) has a high potential in forming a calcific barrier in the pulpal tissue. Yet, in primary dentition Metapex forms a chronic inflammatory reaction to the pulpal tissue leading to its internal and root resorption. Although the high success rate of Metapex in partial pulpectomy, the rapid resorption of Metapex has led to the presence of the hollow tube effect due to voids formation in the canals. However, this will cause early root resorption before the time of exfoliation. Due to its rapid resorption, Metapex is usually recommended to be used in the pulpectomy of teeth near exfoliation in order to avoid the early root resorption of primary dentition in order to avoid the premature loss of the endodontically treated vital primary teeth with Metapex.

Saline solution is the basic irrigating solution in root canal treatments, yet it has no antimicrobial activities and only results in cleaning the root canals. Ethanol irrigation is believed to be an alternative promising replacement in tissue fixation from Formocresol due to the concerns from its carcinogenicity and toxicity. Also, Ethanol has an excellent bactericidal, virucidal, and fungicidal, and most importantly it is one of the volatile liquids.

In this study, the effect of Ethanol Alcohol on increasing the success rate of Metapex in vital pulp therapy will be studied.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

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

4 years to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients medically within normal.
  2. Cooperative patients and cooperative parents.
  3. Children aged 4-7 years old.
  4. Primary mandibular second molar.
  5. Deep carious molars.
  6. A history of spontaneous pain.
  7. Molars with pulp exposure due to caries.
  8. Absences of Internal resorption.
  9. Absences of external pathological resorption.
  10. where the bleeding could not be stopped following removal of the coronal pulp tissue

Exclusion Criteria:

  1. Parents unable to give informed consent.
  2. Necrotic pulp.
  3. Unrestorable Teeth.

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 70% Ethanol
Using 70% Ethanol Alcohol as a root canal irrigating solution before obturating the lower primary second molar with Metapex
Drug: 70% Ethanol Alcohol

Ethanol, also called ethyl alcohol, grain alcohol, or alcohol, a member of a class of organic compounds that are given the general name alcohols.

Ethanol is a commonly used fixative. Fixation of the inner layers of the tissue depends on the ability of the fixative to diffuse into the tissue. Moreover, Ethanol has antibacterial antifungal, and antiviral properties.

70% Ethanol is the safest concentration because the water that has been mixed into the ethanol slows the drying time, creating a longer contact time. Ethanol needs to have a contact time of at least 10 seconds to kill Staphylococcus aureus and Streptococcus pyogenes. At a 10 second drying time.
NO_INTERVENTION: Normal Saline
Irrigating the canals with Normal Saline before obturating the lower primary second molar with Metapex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
Time Frame: Patients will be assessed at 12 months follow ups
Assessment through Visual Analog Scale , A score from (0-10) 0 is means no pain and 10 is the maximum level of pain.
Patients will be assessed at 12 months follow ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic evaluation of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
Time Frame: Patients will be assessed at 12 months follow ups
Assessment through Visual interpretation of digital radiograph
Patients will be assessed at 12 months follow ups

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

December 12, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (ACTUAL)

December 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 24, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12021 (DAIDS-ES Registry Number)

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

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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