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

NCT04669392 | Unknown Early Phase 1 DMC

• 1 other identifier: 12021
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pulpitis - Irreversible; Resorption, Root; Abscess Bone; Mobility, Tooth; Pain

Keywords

Metapex; Primary dentition

Outcome Measures

Primary Outcomes (1)

• Postoperative pain of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.

  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 Outcomes (1)

• Radiographic evaluation of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.

  Patients will be assessed at 12 months follow ups

Study Arms (2)

70% Ethanol

EXPERIMENTAL

Using 70% Ethanol Alcohol as a root canal irrigating solution before obturating the lower primary second molar with Metapex

Drug: 70% Ethanol Alcohol

Normal Saline

NO INTERVENTION

Irrigating the canals with Normal Saline before obturating the lower primary second molar with Metapex

Interventions

70% Ethanol Alcohol DRUG

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.

70% Ethanol

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Parents unable to give informed consent.
• Necrotic pulp.
• Unrestorable Teeth.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (5)

• Brand, C. & At, D. M. E. Guidelines for Disinfection and Sterilization in Healthcare Facilities , 2008 ( Centers for Disease Control ). 2008, (2008).

  BACKGROUND

• Nurko C, Ranly DM, Garcia-Godoy F, Lakshmyya KN. Resorption of a calcium hydroxide/iodoform paste (Vitapex) in root canal therapy for primary teeth: a case report. Pediatr Dent. 2000 Nov-Dec;22(6):517-20.

  PMID: 11132515 RESULT

• Al-Ostwani AO, Al-Monaqel BM, Al-Tinawi MK. A clinical and radiographic study of four different root canal fillings in primary molars. J Indian Soc Pedod Prev Dent. 2016 Jan-Mar;34(1):55-9. doi: 10.4103/0970-4388.175515.

  PMID: 26838149 RESULT

• Thiruvenkadam G, Asokan S, John B, Priya PG. Effect of 95% Ethanol as a Final Irrigant before Root Canal Obturation in Primary Teeth: An in vitro Study. Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):21-4. doi: 10.5005/jp-journals-10005-1327. Epub 2016 Apr 22.

  PMID: 27274150 RESULT

• Panzacchi S, Gnudi F, Mandrioli D, Montella R, Strollo V, Merrick BA, Belpoggi F, Tibaldi E. Effects of short and long-term alcohol-based fixation on Sprague-Dawley rat tissue morphology, protein and nucleic acid preservation. Acta Histochem. 2019 Aug;121(6):750-760. doi: 10.1016/j.acthis.2019.05.011. Epub 2019 Jul 3.

  PMID: 31277893 RESULT

MeSH Terms

Conditions

Root Resorption; Tooth Mobility; Pain

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Tooth Resorption; Tooth Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Thamat Al-Gannah SM Rashed, Bachelor's degree of dentistry

CONTACT

00201111760022; ThamarAlGannah.Mohamed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thamar Al-Gannah Samy Mohamed Rashed

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: December 16, 2020
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: July 29, 2021

Record last verified: 2021-07