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

Cairo University (CU)

Status and phase: Unknown; Early Phase 1

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

Treatments: Drug: 70% Ethanol Alcohol

Study type: Interventional

Funder types: Other

Identifiers

NCT04669392

12021 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

70% Ethanol

Experimental group

Description:

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

Treatment:

Drug: 70% Ethanol Alcohol

Normal Saline

No Intervention group

Description:

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