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
Primary Purpose
Pulpitis - Irreversible, Resorption, Root, Abscess Bone
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
70% Ethanol Alcohol
Sponsored by
About this trial
This is an interventional prevention trial for Pulpitis - Irreversible focused on measuring Metapex, Primary dentition
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Parents unable to give informed consent.
- Necrotic pulp.
- Unrestorable Teeth.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
70% Ethanol
Normal Saline
Arm Description
Using 70% Ethanol Alcohol as a root canal irrigating solution before obturating the lower primary second molar with Metapex
Irrigating the canals with Normal Saline before obturating the lower primary second molar with Metapex
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04669392
Brief Title
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
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible, Resorption, Root, Abscess Bone, Mobility, Tooth, Pain
Keywords
Metapex, Primary dentition
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
70% Ethanol
Arm Type
Experimental
Arm Description
Using 70% Ethanol Alcohol as a root canal irrigating solution before obturating the lower primary second molar with Metapex
Arm Title
Normal Saline
Arm Type
No Intervention
Arm Description
Irrigating the canals with Normal Saline before obturating the lower primary second molar with Metapex
Intervention Type
Drug
Intervention Name(s)
70% Ethanol Alcohol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
Description
Assessment through Visual Analog Scale , A score from (0-10) 0 is means no pain and 10 is the maximum level of pain.
Time Frame
Patients will be assessed at 12 months follow ups
Secondary Outcome Measure Information:
Title
Radiographic evaluation of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
Description
Assessment through Visual interpretation of digital radiograph
Time Frame
Patients will be assessed at 12 months follow ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Parents unable to give informed consent.
Necrotic pulp.
Unrestorable Teeth.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thamat Al-Gannah SM Rashed, Bachelor's degree of dentistry
Phone
00201111760022
Email
ThamarAlGannah.Mohamed@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
Brand, C. & At, D. M. E. Guidelines for Disinfection and Sterilization in Healthcare Facilities , 2008 ( Centers for Disease Control ). 2008, (2008).
Results Reference
background
PubMed Identifier
11132515
Citation
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.
Results Reference
result
PubMed Identifier
26838149
Citation
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.
Results Reference
result
PubMed Identifier
27274150
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.
Results Reference
result
PubMed Identifier
31277893
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(6):750-760. doi: 10.1016/j.acthis.2019.05.011. Epub 2019 Jul 3.
Results Reference
result
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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
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