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

Pain Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04669392
• Other study ID #: 12021
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: Thamat Al-Gannah SM Rashed, Bachelor's degree of dentistry
• Phone: 00201111760022
• Email: ThamarAlGannah.Mohamed[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (5)

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. — View Citation

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

Nurko C, Ranly DM, García-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. — View Citation

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 — View Citation

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 — View Citation

Outcome

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