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

Early Phase 1

• Conditions: Mobility, Tooth; Pain; Resorption, Root; Pulpitis - Irreversible; Abscess Bone
• Interventions: Drug: 70% Ethanol Alcohol

• Registration Number: NCT04669392
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2020-12-12
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-16
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-24
• Last Update Posted: 2021-07-29
• Study Start: 2021-12-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postoperative pain 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	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

Name	Time	Method
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	Assessment through Visual interpretation of digital radiograph